Breeze3:Study of Gabapentin Extended Release in the Treatment of Vasomotor Symptoms(Hot Flashes)in Postmenopausal Women

Study Overview
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Brief Summary
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Depomed's Gabapentin Extended Release is an investigational, extended release formulation of Gabapentin that is being studied for the treatment of Hot Flashes/Hot Flushes in postmenopausal women

Detailed Description
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The primary study objective is to assess the efficacy of G-ER dosed at 1800mg daily (600mg AM, 1200mg PM), compared to placebo in reducing the average daily frequency and severity score of moderate to severe hot flashes in postmenopausal women at weeks 4 & 12 of the efficacy treatment period, compared with baseline.

Official Title
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A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety and Efficacy of Gabapentin Extended Release (G-ER_ Tablets in the Treatment of Vasomotor Symptoms in Postmenopausal Women

Conditions
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Hot Flashes

Intervention / Treatment
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* Drug: Gabapentin Extended Release
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Generally healthy, postmenopausal women who seek treatment for hot flashes Patients using hormone replacement therapy(HRT) must be willing to discontinue treatment Patients must be experiencing moderate to severe hot flashes Patients must be able to sign the informed consent Patients must be able to enter simple commands and complete questionnaires on the frequency and severity of their hot flashes using an electronic diary Other inclusions apply. Exclusion Criteria: Patients with hypersensitivity to Gabapentin Patients with severe chronic diarrhea, chronic constipation, uncontrolled irritable bowel syndrome (IBS) or unexplained weight loss Patients treated with estrogen pellets or injectable progestin drug therapy within 6 months. Patients currently treated with Gabapentin or Pregabalin for any indication, including vasomotor symptoms Other exclusions apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gabapentin Extended Release<br>Active treatment | Drug: Gabapentin Extended Release<br>* Gabapentin ER 1800mg daily<br>|
| Other: Placebo<br>Placebo | Drug: Placebo<br>* Sugar pill<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| G-ER at 1800mg Daily Compared With Placebo in Reducing the Average Daily Frequency of Moderate to Severe Hot Flashes at Weeks 4 & 12 of the Efficacy Treatment Period, Compared With Baseline. | G-ER dosed at 1800mg daily(600mg AM, 1200mg PM), compared with placebo in reducing the average daily frequency of moderate to severe hot flashes in post menopausal women at Week 4 of the efficacy treatment period compared with Baseline and at Week 12 of the efficacy treatment period compared with Baseline. | Baseline, Week 4, and Week 12 | 
| G-ER at 1800mg Daily Compared With Placebo in Reducing the Average Daily Severity Score of Moderate to Severe Hot Flashes at Weeks 4 & 12 of the Efficacy Treatment Period, Compared With Baseline. | G-ER dosed at 1800mg daily(600mg AM, 1200mg PM), compared with placebo in reducing the average daily severity score of moderate to severe hot flashes in post menopausal women (score defined as Mild (1), Moderate (2), and Severe (3)) at Week 4 of the efficacy treatment period compared with Baseline and at Week 12 of the efficacy treatment period compared with Baseline. | Baseline, Week 4, and Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| G-ER at 1800mg Daily Compared With Placebo in Reducing the Average Daily Frequency of Moderate to Severe Hot Flashes at Week 24 of the Efficacy Treatment Period, Compared With Baseline. | G-ER dosed at 1800mg daily(600mg AM, 1200mg PM), compared with placebo in reducing the average daily frequency of moderate to severe hot flashes in post menopausal women at Week 24 of the efficacy treatment period compared with Baseline. | Baseline, Week 24 | 
| G-ER at 1800mg Daily Compared With Placebo in Reducing the Average Daily Severity Score of Moderate to Severe Hot Flashes at Week 24 of the Efficacy Treatment Period, Compared With Baseline. | G-ER dosed at 1800mg daily(600mg AM, 1200mg PM), compared with placebo in reducing the average daily severity score of moderate to severe hot flashes in post menopausal women (score defined as Mild (1), Moderate (2), and Severe (3)) at Week 24 of the efficacy treatment period compared with Baseline. | Baseline, Week 24 | 
| Patient Global Impression of Change (PGIC) Scales at Weeks 12 and 24 of the Efficacy Treatment Period. | Proportion of patients who were categorized as very much or much improved for PGIC at Week 12 and Week 24. Scale range is 6 categories: minimum value = very much worse to maximum value = very much improved. | Week 12 and Week 24 | 
| Clinical Global Impression of Change (CGIC) Scales at Weeks 12 and 24 of the Efficacy Treatment Period. | Proportion of patients who were categorized as very much or much improved in CGIC at Week 12 and Week 24. Scale range is 6 categories: minimum value = very much worse to maximum value = very much improved. | Week 12 and Week 24 | 
| Percent of Patients With 75% or Greater Reduction in Average Daily Frequency of Moderate to Severe Hot Flashes |  | Baseline, Week 12, and Week 24 | 
| Percent of Patients With 75% or Greater Reduction in Average Daily Severity Score of Moderate to Severe Hot Flashes |  | Baseline, Week 12, and Week 24 | 
| Change From Baseline to Weeks 4, Week 12, and Week 24 in Average Daily Sleep Interference Score. | Sleep Interference Score Range: Minimum value = 0, maximum value = 10 Lower scores indicate better outcome (ie, less interference) | Baseline, Week 4, Week 12, and Week 24 | 
| Changes From Baseline in Sleep Quality Scores, Measured by the Insomnia Severity Index (ISI) to Week 4, Week 12, and Week 24 of the Efficacy Treatment Period. | Insomnia Severity Index (ISI) scored on 4-point Likert-scales ('0' not at all - '4' extremely) for 7 sub-categories. Final score is sum of each sub-category generating a total sleep quality score (0-28). Minimum value = 0, maximum value = 28 (Lower scores indicate better outcome (ie, less severity)). | Baseline, Week 4, Week 12, and Week 24 | 
| Changes From Baseline in Quality of Life Scores, Measured by the Menopause-Specific Quality of Life Questionnaire (MENQOL) to Weeks, 4, 12, 24 of the Efficacy Treatment Period. | 4 sub-categories each scored individually: Minimum value = 1, maximum value = 8. Overall summary score was mean of the 4 sub-category scores (minimum = 1 and maximum = 8). Lower scores indicate better outcome (ie, less severity) | Baseline, Week 4, Week 12, and Week 24 | 
| Safety of G-ER Measuring Columbia-Suicide Severity Rating Scale (C-SSRS). | Columbia-Suicide Severity Rating Scale (C-SSRS). Subjects were classified as 0=no suicidal ideation or 1=suicidal ideation. Outcome Measure is number of participants with or without suicidal ideation. Higher counts without suicidal ideation = better outcome. | Week 4, Week 12, Week 24/Early Termination, Week 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hot Flushes, Vasomotor Symptoms, Menopausal Hot Flashes