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Study of Gabapentin Extended Release (G-ER)in the Treatment of Vasomotor (Hot Flashes/Hot Flushes) Symptoms in Postmenopausal Women.

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: NCT00777023
Recruitment Status : Completed
First Posted : October 22, 2008
Results First Posted : February 17, 2012
Last Update Posted : February 22, 2012
Sponsor:
Information provided by (Responsible Party):
Depomed

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Hot Flashes
Interventions Drug: Gabapentin Extended-Release (G-ER) 1200 mg
Drug: Gabapentin Extended-Release (G-ER) 1800 mg
Drug: Placebo
Enrollment 565
Recruitment Details  
Pre-assignment Details A total of 565 patients were randomly assigned to treatment: 190 in G-ER 1800 mg group, 192 in G-ER 1200 mg group, and 183 in placebo group. Of these 565 patients, 559 patients (190 in G-ER 1800 mg group, 186 in 1200 mg group, and 183 in placebo group) received study treatment and were included in intent to treat (ITT) and safety populations.
Arm/Group Title G-ER 1200 mg G-ER 1800 mg Sugar Pill
Hide Arm/Group Description Gabapentin extended-release (G-ER) 1200 mg Gabapentin extended-release (G-ER) 1800 mg Placebo 1200 mg or 1800 mg
Period Title: Overall Study
Started 186 [1] 190 [2] 183 [3]
Completed 151 149 146
Not Completed 35 41 37
Reason Not Completed
Adverse Event             15             21             8
Lack of Efficacy             1             0             14
Protocol Violation             2             1             1
Lost to Follow-up             2             3             3
Death             0             1             0
Withdrawal by Subject             7             7             8
Missing data             1             1             0
Reasons not specified             4             4             2
Last dose date unknown             3             3             1
[1]
192 patients were randomized, but only 186 received study treatment.
[2]
190 patients were randomized, and 190 received study treatment.
[3]
183 patients were randomized, and 183 received study treatment.
Arm/Group Title G-ER 1200 mg G-ER 1800 mg Sugar Pill Total
Hide Arm/Group Description Gabapentin extended-release (G-ER) 1200 mg Gabapentin extended-release (G-ER) 1800 mg Placebo 1200 mg or 1800 mg Total of all reporting groups
Overall Number of Baseline Participants 186 190 183 559
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 186 participants 190 participants 183 participants 559 participants
53.1  (7.0) 53.6  (6.1) 52.9  (6.0) 53.2  (6.4)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 186 participants 190 participants 183 participants 559 participants
<65 years 175 181 177 533
>=65 years 11 9 6 26
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 186 participants 190 participants 183 participants 559 participants
Female
186
 100.0%
190
 100.0%
183
 100.0%
559
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Frequency of hot flashes   [1] 
Mean (Standard Deviation)
Unit of measure:  Hot flashes
Number Analyzed 186 participants 190 participants 183 participants 559 participants
Mild 1.1  (2.0) 1.0  (2.0) 1.7  (2.9) 1.2  (2.3)
Moderate 6.1  (5.8) 5.4  (4.0) 6.2  (5.1) 5.9  (5.0)
Severe 6.7  (5.1) 6.9  (5.5) 6.6  (4.9) 6.8  (5.2)
[1]
Measure Description: Number of hot flashes in a 24-hour period.
1.Primary Outcome
Title Change From Baseline in Average Daily Frequency of Moderate or Severe Hot Flashes After 4 Weeks of Treatment
Hide Description Mean change from baseline in average daily number of moderate or severe hot flashes at stable dose week (SDW) 4 of treatment relative to placebo; last observation carried forward (LOCF) analysis
Time Frame At baseline and 4 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat population
Arm/Group Title G-ER 1200 mg G-ER 1800 mg Sugar Pill
Hide Arm/Group Description:
Gabapentin extended-release (G-ER) 1200 mg
Gabapentin extended-release (G-ER) 1800 mg
Placebo 1200 mg or 1800 mg
Overall Number of Participants Analyzed 186 190 183
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Hot flashes
-7.0
(-7.77 to -6.19)
-6.9
(-7.68 to -6.08)
-5.4
(-6.18 to -4.46)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection G-ER 1200 mg, Sugar Pill
Comments Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily number of moderate or severe hot flashes at SDW 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0024
Comments P value for pairwise test of difference of least square mean change from baseline between G-ER 1200 mg and placebo groups based on F test of type III analysis.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.61
Confidence Interval (2-Sided) 97.5%
-2.80 to -0.42
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.53
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection G-ER 1800 mg, Sugar Pill
Comments Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily number of moderate or severe hot flashes at SDW 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0040
Comments P value for pairwise test of difference of least square mean change from baseline between G-ER 1800 mg and placebo groups based on F test of type III analysis.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.51
Confidence Interval (2-Sided) 97.5%
-2.69 to -0.33
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.52
Estimation Comments [Not Specified]
2.Primary Outcome
Title Change From Baseline in Average Daily Frequency of Moderate or Severe Hot Flashes After 12 Weeks of Treatment
Hide Description Mean change from baseline in average daily number of moderate or severe hot flashes at stable dose week (SDW) 12 of treatment relative to placebo; last observation carried forward (LOCF) analysis
Time Frame At baseline and 12 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population
Arm/Group Title G-ER 1200 mg G-ER 1800 mg Sugar Pill
Hide Arm/Group Description:
Gabapentin extended-release (G-ER) 1200 mg
Gabapentin extended-release (G-ER) 1800 mg
Placebo 1200 mg or 1800 mg
Overall Number of Participants Analyzed 186 190 183
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Hot flashes
-7.7
(-8.50 to -6.97)
-7.3
(-8.06 to -6.52)
-6.2
(-6.96 to -5.38)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection G-ER 1200 mg, Sugar Pill
Comments Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily number of moderate or severe hot flashes at SDW 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0024
Comments P value for pairwise test of difference of least square mean change from baseline between G-ER 1200 mg and placebo groups based on F test of type III analysis.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.56
Confidence Interval (2-Sided) 97.5%
-2.72 to -0.41
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.51
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection G-ER 1800 mg, Sugar Pill
Comments Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily number of moderate or severe hot flashes at SDW 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0281
Comments P value for pairwise test of difference of least square mean change from baseline between G-ER 1800 mg and placebo groups based on F test of type III analysis.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.12
Confidence Interval (2-Sided) 97.5%
-2.26 to 0.02
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.51
Estimation Comments [Not Specified]
3.Primary Outcome
Title Change From Baseline in Average Daily Severity Score of Moderate or Severe Hot Flashes After 4 Weeks of Treatment
Hide Description

Mean change from baseline in average daily severity score of moderate or severe hot flashes at stable dose week (SDW) 4 of treatment relative to placebo; last observation carried forward (LOCF) analysis.

Severity of hot flashes is scored on a scale of 1 to 3 where 1=mild, 2=moderate, 3=severe.

Time Frame At baseline and 4 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population
Arm/Group Title G-ER 1200 mg G-ER 1800 mg Sugar Pill
Hide Arm/Group Description:
Gabapentin extended-release (G-ER) 1200 mg
Gabapentin extended-release (G-ER) 1800 mg
Placebo 1200 mg or 1800 mg
Overall Number of Participants Analyzed 186 190 183
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
-0.5
(-0.63 to -0.40)
-0.6
(-0.76 to -0.53)
-0.4
(-0.49 to -0.25)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection G-ER 1200 mg, Sugar Pill
Comments Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate or severe hot flashes at SDW 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0608
Comments P value for pairwise test of difference of least square mean change from baseline between G-ER 1200 mg and placebo groups based on F test of type III analysis.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.15
Confidence Interval (2-Sided) 97.5%
-0.32 to -0.03
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.08
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection G-ER 1800 mg, Sugar Pill
Comments Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate or severe hot flashes at SDW 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments P value for pairwise test of difference of least square mean change from baseline between G-ER 1800 mg and placebo groups based on F test of type III analysis.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.28
Confidence Interval (2-Sided) 97.5%
-0.45 to -0.11
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.08
Estimation Comments [Not Specified]
4.Primary Outcome
Title Change From Baseline in Average Daily Severity Score of Moderate or Severe Hot Flashes After 12 Weeks of Treatment
Hide Description

Mean change from baseline in average daily severity score of moderate or severe hot flashes at stable dose week (SDW) 12 of treatment relative to placebo; last observation carried forward (LOCF) analysis.

Severity of hot flashes is scored on a scale of 1 to 3 where 1=mild, 2=moderate, 3=severe.

Time Frame At baseline and 12 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population
Arm/Group Title G-ER 1200 mg G-ER 1800 mg Sugar Pill
Hide Arm/Group Description:
Gabapentin extended-release (G-ER) 1200 mg
Gabapentin extended-release (G-ER) 1800 mg
Placebo 1200 mg or 1800 mg
Overall Number of Participants Analyzed 186 190 183
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
-0.8
(-0.90 to -0.61)
-0.8
(-0.97 to -0.68)
-0.5
(-0.69 to -0.39)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection G-ER 1200 mg, Sugar Pill
Comments Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate or severe hot flashes at SDW 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0280
Comments P value for pairwise test of difference of least square mean change from baseline between G-ER 1200 mg and placebo groups based on F test of type III analysis.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.21
Confidence Interval (2-Sided) 97.5%
-0.43 to 0.00
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection G-ER 1800 mg, Sugar Pill
Comments Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate or severe hot flashes at SDW 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0026
Comments P value for pairwise test of difference of least square mean change from baseline between G-ER 1800 mg and placebo groups based on F test of type III analysis.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.29
Confidence Interval (2-Sided) 97.5%
-0.51 to -0.07
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.10
Estimation Comments [Not Specified]
Time Frame Adverse events collected for total of 13 weeks: from baseline to end of stable dosing week (SDW) 12 (treatment Week 13; end-of-treatment period).
Adverse Event Reporting Description Adverse event collection began at baseline and continued through Week 14 follow-up phone call; serious adverse events followed for 30 days after study completion.
 
Arm/Group Title G-ER 1200 mg G-ER 1800 mg Sugar Pill
Hide Arm/Group Description Gabapentin extended-release (G-ER) 1200 mg Gabapentin extended-release (G-ER) 1800 mg Placebo 1200 mg or 1800 mg
All-Cause Mortality
G-ER 1200 mg G-ER 1800 mg Sugar Pill
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
G-ER 1200 mg G-ER 1800 mg Sugar Pill
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/186 (1.08%)      2/190 (1.05%)      2/183 (1.09%)    
General disorders       
Chest pain  1  0/186 (0.00%)  0 1/190 (0.53%)  1 0/183 (0.00%)  0
Injury, poisoning and procedural complications       
Overdose; attempted suicide  1  1/186 (0.54%)  1 0/190 (0.00%)  0 0/183 (0.00%)  0
Accidental overdose  1  0/186 (0.00%)  0 1/190 (0.53%)  1 0/183 (0.00%)  0
Road traffic accident  1  0/186 (0.00%)  0 0/190 (0.00%)  0 1/183 (0.55%)  1
Meniscus lesion  1  0/186 (0.00%)  0 0/190 (0.00%)  0 1/183 (0.55%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Ovarian cancer  1  1/186 (0.54%)  1 0/190 (0.00%)  0 0/183 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (9.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
G-ER 1200 mg G-ER 1800 mg Sugar Pill
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   70/186 (37.63%)      83/190 (43.68%)      29/183 (15.85%)    
Gastrointestinal disorders       
Nausea  1  6/186 (3.23%)  6 14/190 (7.37%)  14 3/183 (1.64%)  3
Nervous system disorders       
Dizziness  1  32/186 (17.20%)  32 36/190 (18.95%)  36 5/183 (2.73%)  5
Headache  1  9/186 (4.84%)  9 14/190 (7.37%)  14 14/183 (7.65%)  14
Somnolence  1  13/186 (6.99%)  13 16/190 (8.42%)  16 6/183 (3.28%)  6
Sedation  1  10/186 (5.38%)  10 3/190 (1.58%)  3 1/183 (0.55%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (9.0)
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 PI agrees that the sponsor shall have the right to the first publication of the results of the study which is intended to be a joint, multi-center publication. Following the first publication, the PI may publish data or results from the study, provide however PI submits the proposed publication to sponsor for review at least 60 days prior to the date of the proposed publication. Sponsor may remove any information that is considered confidential and/or proprietary other than study data.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Head of R&D
Organization: Depomed
Phone: 650-462-5900 ext 108
EMail: msweeney@depomed.com
Layout table for additonal information
Responsible Party: Depomed
ClinicalTrials.gov Identifier: NCT00777023    
Other Study ID Numbers: BREEZE 2
81-0059
First Submitted: October 21, 2008
First Posted: October 22, 2008
Results First Submitted: January 16, 2012
Results First Posted: February 17, 2012
Last Update Posted: February 22, 2012