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Trial record 39 of 89 for:    DESVENLAFAXINE

Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) In The Treatment Of Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT00384033
Recruitment Status : Completed
First Posted : October 4, 2006
Results First Posted : March 15, 2012
Last Update Posted : March 15, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Depressive Disorder, Major
Interventions Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR)
Drug: Placebo
Drug: Duloxetine 60 mg/day
Enrollment 638
Recruitment Details Study was conducted from 27 September 2006 to 28 September 2007 in United States (US) only.
Pre-assignment Details A total of 925 participants were screened for this study and 638 participants were randomized. The remaining 287 participants were not randomized due to screen failures.
Arm/Group Title Placebo DVS SR 50 mg DVS SR 100 mg Duloxetine 60 mg
Hide Arm/Group Description Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week). DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week). DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week). Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
Period Title: Overall Study
Started 164 155 160 159
Treated 161 148 150 157
Completed 123 120 117 119
Not Completed 41 35 43 40
Reason Not Completed
Adverse Event             10             8             11             20
Failed to return             1             3             2             2
Physician Decision             1             0             0             0
Lost to Follow-up             6             12             7             7
Other             2             0             0             0
Protocol Violation             5             0             5             6
Withdrawal by Subject             6             2             5             2
Lack of Efficacy             7             3             3             1
Randomized but not treated             3             7             10             2
Arm/Group Title Placebo DVS SR 50 mg DVS SR 100 mg Duloxetine 60 mg Total
Hide Arm/Group Description Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week). DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week). DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week). Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week). Total of all reporting groups
Overall Number of Baseline Participants 161 148 150 157 616
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 161 participants 148 participants 150 participants 157 participants 616 participants
39.24  (12.74) 40.67  (13.20) 38.77  (12.07) 38.94  (12.01) 39.39  (12.50)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 161 participants 148 participants 150 participants 157 participants 616 participants
Female
94
  58.4%
102
  68.9%
99
  66.0%
104
  66.2%
399
  64.8%
Male
67
  41.6%
46
  31.1%
51
  34.0%
53
  33.8%
217
  35.2%
Hamilton psychiatric scale for depression-17 item (HAM-D17) total score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a Scale
Number Analyzed 161 participants 148 participants 150 participants 157 participants 616 participants
23.86  (2.68) 23.49  (2.52) 23.49  (2.55) 22.99  (2.45) 23.46  (2.57)
[1]
Measure Description: HAM-D17: a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0 = none/absent and 4 = most severe, for a maximum total score of 50. N=160 for placebo treatment group.
Clinical global impressions scale-severity (CGI-S) score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a Scale
Number Analyzed 161 participants 148 participants 150 participants 157 participants 616 participants
4.39  (0.54) 4.29  (0.48) 4.31  (0.49) 4.28  (0.46) 4.32  (0.50)
[1]
Measure Description: CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill participants). Higher score = more affected. N=160 for placebo treatment group.
1.Primary Outcome
Title Change From Baseline in HAM-D17 Total Score at Week 8 or Final On-therapy (FOT) Evaluation
Hide Description HAM-D17: a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0 = none/absent and 4 = most severe, for a maximum total score of 50.
Time Frame Baseline and Week 8 or FOT
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication.
Arm/Group Title Placebo DVS SR 50 mg DVS SR 100 mg Duloxetine 60 mg
Hide Arm/Group Description:
Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
Overall Number of Participants Analyzed 160 148 150 157
Mean (Standard Error)
Unit of Measure: Units on a Scale
-8.68  (0.58) -9.75  (0.60) -10.5  (0.60) -10.3  (0.60)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments For DVS SR 50 mg, HAM-D17 total score was evaluated using analysis of covariance (ANCOVA) with treatment and site as factors and baseline HAM-D17 score as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.198
Comments The analysis was done at a significance level of alpha = 0.05, 2-sided. Global F-test was used to adjust for multiplicity. If global F-test was significant at 0.05 level, pair wise analysis was interpreted without any further p-value adjustment.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.10
Confidence Interval (2-Sided) 95%
-0.60 to 2.70
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 100 mg
Comments For DVS SR 100 mg, HAM-D17 total score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D17 score as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.028
Comments The analysis was done at a significance level of alpha = 0.05, 2-sided. Global F-test was used to adjust for multiplicity. If global F-test was significant at 0.05 level, pair wise analysis was interpreted without any further p-value adjustment.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.80
Confidence Interval (2-Sided) 95%
0.20 to 3.40
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 60 mg
Comments For Duloxetine 60 mg, HAM-D17 total score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D17 score as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.047
Comments The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.70
Confidence Interval (2-Sided) 95%
0.00 to 3.40
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With Categorical Scores on CGI-Improvement (CGI-I) Score at Week 8 or FOT Evaluation
Hide Description CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale relative to the baseline assessment. Higher score = more affected.
Time Frame Week 8 or FOT
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication.
Arm/Group Title Placebo DVS SR 50 mg DVS SR 100 mg Duloxetine 60 mg
Hide Arm/Group Description:
Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
Overall Number of Participants Analyzed 160 148 150 157
Measure Type: Number
Unit of Measure: Participants
1 = Very much improved 31 27 45 45
2 = Much improved 32 38 37 35
3 = Minimally improved 35 47 28 37
4 = No change 57 34 37 37
5 = Minimally worse 5 2 2 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments For DVS SR 50 mg, CGI-I was evaluated using Cochran-Mantel-Haenszel (CMH) test with treatment as a factor and controlling for center.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.110
Comments The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 100 mg
Comments For DVS SR 100 mg, CGI-I was evaluated using CMH test with treatment as a factor and controlling for center.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 60 mg
Comments For Duloxetine 60 mg, CGI-I was evaluated using CMH test with treatment as a factor and controlling for center.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Mean CGI-S Score at Week 8 or FOT Evaluation
Hide Description CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill participants). Higher score = more affected.
Time Frame Baseline and Week 8 or FOT
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication.
Arm/Group Title Placebo DVS SR 50 mg DVS SR 100 mg Duloxetine 60 mg
Hide Arm/Group Description:
Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
Overall Number of Participants Analyzed 160 148 150 157
Mean (Standard Error)
Unit of Measure: Units on a Scale
-1.10  (0.09) -1.25  (0.10) -1.44  (0.10) -1.41  (0.10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments For DVS SR 50 mg, CGI-S was evaluated using ANCOVA with treatment and site as factors and baseline CGI-S score as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.248
Comments The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.20
Confidence Interval (2-Sided) 95%
-0.10 to 0.40
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 100 mg
Comments For DVS SR 100 mg, CGI-S was evaluated using ANCOVA with treatment and site as factors and baseline CGI-S score as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.30
Confidence Interval (2-Sided) 95%
0.10 to 0.60
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 60 mg
Comments For Duloxetine 60 mg, CGI-S was evaluated using ANCOVA with treatment and site as factors and baseline CGI-S score as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.026
Comments The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.30
Confidence Interval (2-Sided) 95%
0.00 to 0.60
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score at Week 8 or FOT Evaluation
Hide Description MADRS measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
Time Frame Baseline and Week 8 or FOT
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication.
Arm/Group Title Placebo DVS SR 50 mg DVS SR 100 mg Duloxetine 60 mg
Hide Arm/Group Description:
Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
Overall Number of Participants Analyzed 160 148 150 157
Mean (Standard Error)
Unit of Measure: Units on a Scale
Baseline 31.10 [1]   (NA) 30.10 [2]   (NA) 30.70 [2]   (NA) 30.80 [2]   (NA)
Change at Week 8 or FOT -11.00  (0.82) -12.70  (0.85) -14.40  (0.84) -14.40  (0.87)
[1]
Standard error (SE) for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.
[2]
SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments For DVS SR 50 mg, MADRS total score was evaluated using ANCOVA with treatment and site as factors and baseline MADRS score as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.149
Comments The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.70
Confidence Interval (2-Sided) 95%
-0.60 to 4.00
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 100 mg
Comments For DVS SR 100 mg, MADRS total score was evaluated using ANCOVA with treatment and site as factors and baseline MADRS score as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.30
Confidence Interval (2-Sided) 95%
1.10 to 5.60
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 60 mg
Comments For Duloxetine 60 mg, MADRS total score was evaluated using ANCOVA with treatment and site as factors and baseline MADRS score as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.40
Confidence Interval (2-Sided) 95%
1.10 to 5.80
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in the Lassitude Item of the MADRS Scale at Week 8 or FOT Evaluation
Hide Description Lassitude item of MADRS represents a difficulty in getting started or slowness in initiating and performing everyday activities. It is rated on a scale of 0-6: 0 = hardly any difficulty in getting started/no sluggishness; 2 = difficulties in starting activities; 4 = difficulties in starting simple routine activities which are carried out with effort; 6 = complete lassitude/unable to do anything without help.
Time Frame Baseline and Week 8 or FOT
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication.
Arm/Group Title Placebo DVS SR 50 mg DVS SR 100 mg Duloxetine 60 mg
Hide Arm/Group Description:
Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
Overall Number of Participants Analyzed 160 148 150 157
Mean (Standard Error)
Unit of Measure: Units on a Scale
Baseline 3.49 [1]   (NA) 3.53 [1]   (NA) 3.70 [1]   (NA) 3.50 [1]   (NA)
Change at Week 8 or FOT -1.27  (0.12) -1.39  (0.13) -1.54  (0.13) -1.26  (0.12)
[1]
SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments For DVS SR 50 mg, lassitude item of the MADRS score was evaluated using ANCOVA with treatment and site as factors and baseline lassitude item of the MADRS score as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.473
Comments The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.12
Confidence Interval (2-Sided) 95%
-0.22 to 0.46
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 100 mg
Comments For DVS SR 100 mg, lassitude item of the MADRS score was evaluated using ANCOVA with treatment and site as factors and baseline lassitude item of the MADRS score as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.119
Comments The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.27
Confidence Interval (2-Sided) 95%
-0.07 to 0.61
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 60 mg
Comments For Duloxetine 60 mg, lassitude item of the MADRS score was evaluated using ANCOVA with treatment and site as factors and baseline lassitude item of the MADRS score as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.710
Comments The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.06
Confidence Interval (2-Sided) 95%
-0.27 to 0.40
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in HAM-D6 Total Score at Week 8 or FOT Evaluation
Hide Description HAM-D6: a standardized, clinician-administered rating scale that assesses 6 items characteristically associated with major depression and is a subset of HAM-D17. HAM-D6 score ranges from 0-22. The scale uses HAM-D17 items: 1, 2, 7, 8, 10 and 13. Item 13 is scored 0-2 (0=none and 2=severe) and all others are scored 0-4 (0=none/absent and 4=most severe).
Time Frame Baseline and Week 8 or FOT
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication.
Arm/Group Title Placebo DVS SR 50 mg DVS SR 100 mg Duloxetine 60 mg
Hide Arm/Group Description:
Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
Overall Number of Participants Analyzed 160 148 150 157
Mean (Standard Error)
Unit of Measure: Units on a Scale
Baseline 13.00 [1]   (NA) 12.80 [1]   (NA) 12.90 [1]   (NA) 12.90 [1]   (NA)
Change at Week 8 or FOT -4.82  (0.33) -5.41  (0.35) -6.15  (0.34) -5.91  (0.36)
[1]
SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments For DVS SR 50 mg, HAM-D6 score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D6 score as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.215
Comments The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.60
Confidence Interval (2-Sided) 95%
-0.30 to 1.50
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 100 mg
Comments For DVS SR 100 mg, HAM-D6 score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D6 score as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.30
Confidence Interval (2-Sided) 95%
0.40 to 2.30
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 60 mg
Comments For Duloxetine 60 mg, HAM-D6 score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D6 score as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.024
Comments The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.1
Confidence Interval (2-Sided) 95%
0.20 to 2.10
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in the HAM-D Energy Subscale Score at Week 8 or FOT Evaluation
Hide Description HAM-D energy subscale is a subset of the HAM-D17 that assesses 4 items associated with major depression. The scale uses HAM- D17 items 1, 7, 8 and 14. Item 14 is scored 0 to 2 (0=none/absent to 2=most severe) and all others are scored 0 to 4 (0=none/absent to 4=most severe).
Time Frame Baseline and Week 8 or FOT
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication.
Arm/Group Title Placebo DVS SR 50 mg DVS SR 100 mg Duloxetine 60 mg
Hide Arm/Group Description:
Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
Overall Number of Participants Analyzed 160 148 150 157
Mean (Standard Error)
Unit of Measure: Units on a Scale
Baseline 8.38 [1]   (NA) 8.43 [1]   (NA) 8.51 [1]   (NA) 8.38 [1]   (NA)
Change at Week 8 or FOT -3.13  (0.23) -3.66  (0.23) -3.92  (0.23) -3.80  (0.24)
[1]
SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments For DVS SR 50 mg, HAM-D energy subscale score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D energy score as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.100
Comments The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.53
Confidence Interval (2-Sided) 95%
-0.10 to 1.17
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 100 mg
Comments For DVS SR 100 mg, HAM-D energy subscale score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D energy score as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
Comments The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.79
Confidence Interval (2-Sided) 95%
0.16 to 1.42
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 60 mg
Comments For Duloxetine 60 mg, HAM-D energy subscale score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D energy score as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.032
Comments The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.72
Confidence Interval (2-Sided) 95%
0.06 to 1.38
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in Covi Anxiety Scale at Week 8 or FOT Evaluation
Hide Description COVI anxiety scale measures the severity of anxiety symptoms on 3 items: verbal report, behavior and somatic complaints. Each dimension is assessed using a 5-point scale: 1 = not at all, 2 = somewhat, 3 = moderately, 4 = considerably, to 5 = Very much. Worst value is 15 and best value is 3.
Time Frame Baseline and Week 8 or FOT
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication.
Arm/Group Title Placebo DVS SR 50 mg DVS SR 100 mg Duloxetine 60 mg
Hide Arm/Group Description:
Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
Overall Number of Participants Analyzed 160 148 150 157
Mean (Standard Error)
Unit of Measure: Units on a Scale
Baseline 6.50 [1]   (NA) 6.30 [1]   (NA) 6.30 [1]   (NA) 6.30 [1]   (NA)
Change at Week 8 or FOT -1.02  (0.12) -1.15  (0.13) -1.35  (0.13) -1.47  (0.13)
[1]
SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments For DVS SR 50 mg, Covi anxiety scale was evaluated using ANCOVA with treatment and site as factors and baseline Covi anxiety score as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.445
Comments The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.10
Confidence Interval (2-Sided) 95%
-0.20 to 0.50
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 100 mg
Comments For DVS SR 100 mg, Covi anxiety scale was evaluated using ANCOVA with treatment and site as factors and baseline Covi anxiety score as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.056
Comments The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.30
Confidence Interval (2-Sided) 95%
-0.00 to 0.70
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 60 mg
Comments For Duloxetine 60 mg, Covi anxiety scale was evaluated using ANCOVA with treatment and site as factors and baseline Covi anxiety score as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.50
Confidence Interval (2-Sided) 95%
0.10 to 0.90
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline in Visual Analog Scale-Pain Intensity (VAS-PI) Overall and Subcomponent Score at Week 8 or FOT Evaluation
Hide Description VAS-PI scale assesses intensity of back pain, chest pain, arms, legs or joint pain as well as overall pain intensity where 100 mm line (VAS) is marked by participant and intensity of pain ranges from 0 millimetre (mm) = no pain to 100 mm = worst possible pain. There were separate 0 to 100 mm VAS lines for each subcomponent of VAS-PI.
Time Frame Baseline and Week 8 or FOT
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication.
Arm/Group Title Placebo DVS SR 50 mg DVS SR 100 mg Duloxetine 60 mg
Hide Arm/Group Description:
Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
Overall Number of Participants Analyzed 160 148 150 157
Mean (Standard Error)
Unit of Measure: mm
Overall pain (Baseline) 26.30 [1]   (NA) 30.80 [1]   (NA) 25.90 [1]   (NA) 26.10 [1]   (NA)
Stomach pain (Baseline) 16.70 [1]   (NA) 19.40 [1]   (NA) 17.00 [1]   (NA) 14.00 [1]   (NA)
Back pain (Baseline) 25.90 [1]   (NA) 32.90 [1]   (NA) 28.30 [1]   (NA) 25.50 [1]   (NA)
Chest pain (Baseline) 9.40 [1]   (NA) 10.90 [1]   (NA) 10.40 [1]   (NA) 6.60 [1]   (NA)
Arms, legs or joint pain (Baseline) 25.80 [1]   (NA) 29.10 [1]   (NA) 28.70 [1]   (NA) 22.40 [1]   (NA)
Overall pain (Change at Week 8 or FOT) -5.61  (1.57) -9.08  (1.64) -10.30  (1.63) -8.84  (1.74)
Stomach pain (Change at Week 8 or FOT) -1.86  (1.62) -4.98  (1.69) -6.42  (1.68) -4.38  (1.58)
Back pain (Change at Week 8 or FOT) -7.04  (1.67) -10.70  (1.74) -12.80  (1.73) -9.33  (1.83)
Chest pain (Change at Week 8 or FOT) -1.95  (1.12) -3.34  (1.17) -3.90  (1.16) -1.67  (1.21)
Arms, legs or joint pain (Change at Week 8 or FOT) -6.99  (1.70) -8.98  (1.76) -11.90  (1.76) -8.35  (1.64)
[1]
SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments For DVS SR 50 mg, overall VAS-PI score was evaluated using ANCOVA with treatment and site as factors and baseline VAS-PI score as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.124
Comments The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.50
Confidence Interval (2-Sided) 95%
-0.90 to 7.90
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 100 mg
Comments For DVS SR 100 mg, overall VAS-PI score was evaluated using ANCOVA with treatment and site as factors and baseline VAS-PI score as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.035
Comments The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.7
Confidence Interval (2-Sided) 95%
0.30 to 9.10
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 60 mg
Comments For Duloxetine 60 mg, overall VAS-PI score was evaluated using ANCOVA with treatment and site as factors and baseline VAS-PI score as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.093
Comments The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 4.10
Confidence Interval (2-Sided) 95%
-0.70 to 8.80
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments For DVS SR 50 mg, stomach pain score was evaluated using ANCOVA with treatment and site as factors and baseline stomach pain score as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.177
Comments The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.10
Confidence Interval (2-Sided) 95%
-1.40 to 7.70
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 100 mg
Comments For DVS SR 100 mg, stomach pain score was evaluated using ANCOVA with treatment and site as factors and baseline stomach pain score as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.048
Comments The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.60
Confidence Interval (2-Sided) 95%
0.10 to 9.10
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 60 mg
Comments For Duloxetine 60 mg, stomach pain score was evaluated using ANCOVA with treatment and site as factors and baseline stomach pain score as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.088
Comments The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.80
Confidence Interval (2-Sided) 95%
-0.50 to 8.10
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments For DVS SR 50 mg, back pain score was evaluated using ANCOVA with treatment and site as factors and baseline back pain score as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.122
Comments The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.70
Confidence Interval (2-Sided) 95%
-1.00 to 8.40
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 100 mg
Comments For DVS SR 100 mg, back pain score was evaluated using ANCOVA with treatment and site as factors and baseline back pain score as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.015
Comments The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 5.80
Confidence Interval (2-Sided) 95%
1.10 to 10.50
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 60 mg
Comments For Duloxetine 60 mg, back pain score was evaluated using ANCOVA with treatment and site as factors and baseline back pain score as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.103
Comments The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.20
Confidence Interval (2-Sided) 95%
-0.80 to 9.20
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments For DVS SR 50 mg, chest pain score was evaluated using ANCOVA with treatment and site as factors and baseline chest pain score as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.384
Comments The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.40
Confidence Interval (2-Sided) 95%
-1.70 to 4.50
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 100 mg
Comments For DVS SR 100 mg, chest pain score was evaluated using ANCOVA with treatment and site as factors and baseline chest pain score as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.221
Comments The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.00
Confidence Interval (2-Sided) 95%
-1.20 to 5.10
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 60 mg
Comments For Duloxetine 60 mg, chest pain score was evaluated using ANCOVA with treatment and site as factors and baseline chest pain score as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.411
Comments The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.40
Confidence Interval (2-Sided) 95%
-1.90 to 4.70
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments For DVS SR 50 mg, arms, legs, joint pain score was evaluated using ANCOVA with treatment and site as factors and baseline arms, legs, pain score as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.412
Comments The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.00
Confidence Interval (2-Sided) 95%
-2.80 to 6.70
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 100 mg
Comments For DVS SR 100 mg, arms, legs, joint pain score was evaluated using ANCOVA with treatment and site as factors and baseline arms, legs, pain score as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.042
Comments The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.90
Confidence Interval (2-Sided) 95%
0.20 to 9.60
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 60 mg
Comments For Duloxetine 60 mg, arms, legs, joint pain score was evaluated using ANCOVA with treatment and site as factors and baseline arms, legs, pain score as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.155
Comments The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.30
Confidence Interval (2-Sided) 95%
-1.20 to 7.80
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Placebo DVS SR 50 mg DVS SR 100 mg Duloxetine 60 mg
Hide Arm/Group Description Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week). DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week). DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week). Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
All-Cause Mortality
Placebo DVS SR 50 mg DVS SR 100 mg Duloxetine 60 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo DVS SR 50 mg DVS SR 100 mg Duloxetine 60 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/161 (1.24%)   2/148 (1.35%)   2/150 (1.33%)   1/157 (0.64%) 
Gastrointestinal disorders         
Gastrointestinal hemorrhage * 1  0/161 (0.00%)  0/148 (0.00%)  1/150 (0.67%)  0/157 (0.00%) 
General disorders         
Accidental injury * 1  1/161 (0.62%)  1/148 (0.68%)  0/150 (0.00%)  0/157 (0.00%) 
Suicide attempt * 1  0/161 (0.00%)  0/148 (0.00%)  0/150 (0.00%)  1/157 (0.64%) 
Nervous system disorders         
Suicidal ideation * 1  0/161 (0.00%)  1/148 (0.68%)  0/150 (0.00%)  0/157 (0.00%) 
Renal and urinary disorders         
Menorrhagia * 1  0/161 (0.00%)  0/148 (0.00%)  1/150 (0.67%)  0/157 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Asthma * 1  1/161 (0.62%)  0/148 (0.00%)  0/150 (0.00%)  0/157 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, COSTART
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo DVS SR 50 mg DVS SR 100 mg Duloxetine 60 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   129/161 (80.12%)   134/148 (90.54%)   134/150 (89.33%)   141/157 (89.81%) 
Gastrointestinal disorders         
Anorexia * 1  7/161 (4.35%)  14/148 (9.46%)  14/150 (9.33%)  29/157 (18.47%) 
Constipation * 1  5/161 (3.11%)  9/148 (6.08%)  10/150 (6.67%)  17/157 (10.83%) 
Diarrhea * 1  22/161 (13.66%)  18/148 (12.16%)  24/150 (16.00%)  26/157 (16.56%) 
Dry mouth * 1  25/161 (15.53%)  26/148 (17.57%)  31/150 (20.67%)  33/157 (21.02%) 
Dyspepsia * 1  9/161 (5.59%)  8/148 (5.41%)  10/150 (6.67%)  7/157 (4.46%) 
Nausea * 1  22/161 (13.66%)  36/148 (24.32%)  40/150 (26.67%)  52/157 (33.12%) 
Vomitting * 1  4/161 (2.48%)  3/148 (2.03%)  11/150 (7.33%)  14/157 (8.92%) 
General disorders         
Abdominal pain * 1  12/161 (7.45%)  8/148 (5.41%)  8/150 (5.33%)  15/157 (9.55%) 
Asthenia * 1  9/161 (5.59%)  15/148 (10.14%)  19/150 (12.67%)  21/157 (13.38%) 
Back pain * 1  10/161 (6.21%)  3/148 (2.03%)  0/150 (0.00%)  5/157 (3.18%) 
Flu syndrome * 1  8/161 (4.97%)  7/148 (4.73%)  12/150 (8.00%)  5/157 (3.18%) 
Headache * 1  38/161 (23.60%)  27/148 (18.24%)  28/150 (18.67%)  30/157 (19.11%) 
Infection * 1  7/161 (4.35%)  10/148 (6.76%)  15/150 (10.00%)  6/157 (3.82%) 
Pain * 1  9/161 (5.59%)  3/148 (2.03%)  4/150 (2.67%)  4/157 (2.55%) 
Withdrawal syndrome * 1  24/161 (14.91%)  42/148 (28.38%)  42/150 (28.00%)  49/157 (31.21%) 
Abnormal vision * 1  2/161 (1.24%)  8/148 (5.41%)  9/150 (6.00%)  4/157 (2.55%) 
Musculoskeletal and connective tissue disorders         
Myalgia * 1  9/161 (5.59%)  6/148 (4.05%)  6/150 (4.00%)  5/157 (3.18%) 
Nervous system disorders         
Abnormal dreams * 1  3/161 (1.86%)  5/148 (3.38%)  5/150 (3.33%)  12/157 (7.64%) 
Anxiety * 1  11/161 (6.83%)  4/148 (2.70%)  2/150 (1.33%)  4/157 (2.55%) 
Dizziness * 1  15/161 (9.32%)  15/148 (10.14%)  26/150 (17.33%)  27/157 (17.20%) 
Insomnia * 1  9/161 (5.59%)  23/148 (15.54%)  28/150 (18.67%)  37/157 (23.57%) 
Somnolence * 1  12/161 (7.45%)  16/148 (10.81%)  18/150 (12.00%)  33/157 (21.02%) 
Respiratory, thoracic and mediastinal disorders         
Upper respiratory infection * 1  20/161 (12.42%)  24/148 (16.22%)  20/150 (13.33%)  25/157 (15.92%) 
Skin and subcutaneous tissue disorders         
Sweating * 1  4/161 (2.48%)  9/148 (6.08%)  9/150 (6.00%)  19/157 (12.10%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, COSTART
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00384033     History of Changes
Other Study ID Numbers: 3151A1-335
First Submitted: October 2, 2006
First Posted: October 4, 2006
Results First Submitted: February 9, 2012
Results First Posted: March 15, 2012
Last Update Posted: March 15, 2012