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A Study Evaluating Desvenlafaxine Sustained Release (DVS SR) in Adult Female Outpatients With Fibromyalgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00696787
Recruitment Status : Terminated
First Posted : June 13, 2008
Results First Posted : February 23, 2010
Last Update Posted : February 25, 2013
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Fibromyalgia
Interventions Drug: Desvenlafaxine Sustained Release (DVS SR)
Drug: Lyrica® (Pregabalin)
Drug: Placebo
Enrollment 125
Recruitment Details Subjects were recruited in the United States from June 2006 to November 2008.
Pre-assignment Details After a 7 to 30 day screening period, eligible subjects entered a 7 day single blind placebo run-in period during which placebo responses were assessed.
Arm/Group Title Placebo DVS SR Pregabalin
Hide Arm/Group Description In the first stage, subjects were randomly assigned to receive placebo. Study was stopped after stage 1 by sponsor. In the first stage, subjects were randomly assigned to receive DVS SR 200 mg/day. Study was stopped after stage 1 by sponsor. In the first stage, subjects were randomly assigned to receive Pregabalin 450 mg/day. Study was stopped after stage 1 by sponsor.
Period Title: Overall Study
Started 40 42 43
Completed 25 22 17
Not Completed 15 20 26
Reason Not Completed
Adverse Event             1             0             6
Discontinuation by Sponsor             9             13             14
Lack of Efficacy             0             1             0
Lost to Follow-up             4             0             3
Withdrawal by Subject             0             3             2
Failed to return             1             3             1
Arm/Group Title Placebo DVS SR Pregabalin Total
Hide Arm/Group Description In the first stage, subjects were randomly assigned to receive placebo. Study was stopped after stage 1 by sponsor. In the first stage, subjects were randomly assigned to receive DVS SR 200 mg/day. Study was stopped after stage 1 by sponsor. In the first stage, subjects were randomly assigned to receive Pregabalin 450 mg/day. Study was stopped after stage 1 by sponsor. Total of all reporting groups
Overall Number of Baseline Participants 40 42 43 125
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 42 participants 43 participants 125 participants
46.90  (12.65) 47.83  (10.53) 45.42  (12.11) 46.70  (11.74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 42 participants 43 participants 125 participants
Female
40
 100.0%
42
 100.0%
43
 100.0%
125
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Change From Baseline on the Numeric Rating Scale (NRS)
Hide Description The primary efficacy variable was the change from baseline on the NRS. The primary time point was the average pain score during the last data-analysis-interval of week 8. The baseline score was the average of the NRS scores across the last 7 days of the screening period (just prior to the start of the placebo run-in). The primary efficacy variable was the pain severity score measured on an 11 point NRS on which 0=no pain and 10=worst possible pain.
Time Frame Baseline and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The Modified Intent to Treat (MITT) population included all randomized subjects who had taken at least one dose of double-blind test article, who had a baseline primary efficacy evaluation, and who had at least one primary efficacy evaluation on double-blind therapy.
Arm/Group Title Placebo DVS SR Pregabalin
Hide Arm/Group Description:
In the first stage, subjects were randomly assigned to receive placebo. Study was stopped after stage 1 by sponsor.
In the first stage, subjects were randomly assigned to receive DVS SR 200 mg/day. Study was stopped after stage 1 by sponsor.
In the first stage, subjects were randomly assigned to receive Pregabalin 450 mg/day. Study was stopped after stage 1 by sponsor.
Overall Number of Participants Analyzed 40 42 43
Mean (Standard Error)
Unit of Measure: units on scale
-1.98  (0.37) -1.60  (0.37) -1.70  (0.38)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.471
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean
Estimated Value -0.38
Confidence Interval (2-Sided) 95%
-1.42 to 0.66
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.604
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean
Estimated Value -0.28
Confidence Interval (2-Sided) 95%
-1.33 to 0.77
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline on the Numeric Rating Scale (NRS) in the Treatment of Pain Associated With Fibromyalgia in Adult Female Outpatients
Hide Description The efficacy variable was the change from baseline on the numeric rating scale (NRS). The time point was the average pain score during the last data-analysis-interval of week 8, data analysis interval. The baseline score was the average of the NRS scores across the last 7 days of the screening period (just prior to the start of the placebo run-in). The efficacy variable was the pain severity score measured on an 11 point NRS on which 0=no pain and 10=worst possible pain.
Time Frame Baseline and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects who had taken at least one dose of double-blind test article, had a baseline primary efficacy evaluation, and had at least one primary efficacy evaluation on double-blind therapy. Subjects who did not complete the study due to its discontinuation were excluded.
Arm/Group Title Placebo DVS SR Pregabalin
Hide Arm/Group Description:
In the first stage, subjects were randomly assigned to receive placebo. Study was stopped after stage 1 by sponsor.
In the first stage, subjects were randomly assigned to receive DVS SR 200 mg/day. Study was stopped after stage 1 by sponsor.
In the first stage, subjects were randomly assigned to receive Pregabalin 450 mg/day. Study was stopped after stage 1 by sponsor.
Overall Number of Participants Analyzed 31 29 29
Mean (Standard Error)
Unit of Measure: units on scale
-2.00  (0.37) -1.64  (0.39) -1.45  (0.40)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.510
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean
Estimated Value -0.35
Confidence Interval (2-Sided) 95%
-1.42 to 0.71
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.317
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean
Estimated Value -0.55
Confidence Interval (2-Sided) 95%
-1.64 to 0.54
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo DVS SR Pregabalin
Hide Arm/Group Description In the first stage, subjects were randomly assigned to receive placebo. Study was stopped after stage 1 by sponsor. In the first stage, subjects were randomly assigned to receive DVS SR 200 mg/day. Study was stopped after stage 1 by sponsor. In the first stage, subjects were randomly assigned to receive Pregabalin 450 mg/day. Study was stopped after stage 1 by sponsor.
All-Cause Mortality
Placebo DVS SR Pregabalin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo DVS SR Pregabalin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/42 (0.00%)   1/43 (2.33%) 
Reproductive system and breast disorders       
Pregnancy and spontaneous abortion *  0/40 (0.00%)  0/42 (0.00%)  1/43 (2.33%) 
*
Indicates events were collected by non-systematic assessment
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 Pregabalin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   25/40 (62.50%)   25/42 (59.52%)   32/43 (74.42%) 
Eye disorders       
Eye disorders general *  1/40 (2.50%)  0/42 (0.00%)  3/43 (6.98%) 
Gastrointestinal disorders       
Constipation *  1/40 (2.50%)  5/42 (11.90%)  1/43 (2.33%) 
Diarrhoea *  2/40 (5.00%)  1/42 (2.38%)  1/43 (2.33%) 
Dry mouth *  2/40 (5.00%)  2/42 (4.76%)  2/43 (4.65%) 
Nausea *  4/40 (10.00%)  6/42 (14.29%)  3/43 (6.98%) 
Vomiting *  3/40 (7.50%)  2/42 (4.76%)  0/43 (0.00%) 
General disorders       
Fatigue *  0/40 (0.00%)  1/42 (2.38%)  3/43 (6.98%) 
Infections and infestations       
Upper respiratory tract infection *  2/40 (5.00%)  1/42 (2.38%)  5/43 (11.63%) 
Injury, poisoning and procedural complications       
Injury, poisoning and procedural complications general *  2/40 (5.00%)  1/42 (2.38%)  3/43 (6.98%) 
Metabolism and nutrition disorders       
Metabolism and nutrition disorders general *  1/40 (2.50%)  2/42 (4.76%)  3/43 (6.98%) 
Musculoskeletal and connective tissue disorders       
Arthralgia *  2/40 (5.00%)  1/42 (2.38%)  0/43 (0.00%) 
Myalgia *  2/40 (5.00%)  0/42 (0.00%)  0/43 (0.00%) 
Nervous system disorders       
Dizziness *  1/40 (2.50%)  2/42 (4.76%)  16/43 (37.21%) 
Headache *  4/40 (10.00%)  2/42 (4.76%)  5/43 (11.63%) 
Migraine *  2/40 (5.00%)  0/42 (0.00%)  1/43 (2.33%) 
Somnolence *  4/40 (10.00%)  2/42 (4.76%)  6/43 (13.95%) 
Psychiatric disorders       
Insomnia *  4/40 (10.00%)  1/42 (2.38%)  0/43 (0.00%) 
Reproductive system and breast disorders       
Reproductive system and breast disorders general *  2/40 (5.00%)  0/42 (0.00%)  0/43 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Respiratory, thoracic and mediastinal disorders general *  3/40 (7.50%)  2/42 (4.76%)  1/43 (2.33%) 
Skin and subcutaneous tissue disorders       
Skin and subcutaneous tissue disorders general *  0/40 (0.00%)  5/42 (11.90%)  3/43 (6.98%) 
*
Indicates events were collected by non-systematic assessment
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.
The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: U. S. Contact Center
Organization: Wyeth
EMail: clintrialresults@wyeth.com
Layout table for additonal information
Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00696787     History of Changes
Other Study ID Numbers: 3151A4-2003
First Submitted: June 11, 2008
First Posted: June 13, 2008
Results First Submitted: January 29, 2010
Results First Posted: February 23, 2010
Last Update Posted: February 25, 2013