Breeze3:Study of Gabapentin Extended Release in the Treatment of Vasomotor Symptoms(Hot Flashes)in Postmenopausal Women
- Registration Number
- NCT01080300
- Lead Sponsor
- Depomed
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 600
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Gabapentin Extended Release Gabapentin Extended Release Active treatment Placebo Placebo Placebo
- Primary Outcome Measures
Name Time Method 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. Baseline, Week 4, and Week 12 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.
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. Baseline, Week 4, and Week 12 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.
- Secondary Outcome Measures
Name Time Method 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. Baseline, Week 24 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.
Clinical Global Impression of Change (CGIC) Scales at Weeks 12 and 24 of the Efficacy Treatment Period. Week 12 and Week 24 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".
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. Baseline, Week 4, Week 12, and Week 24 Sleep Interference Score Range: Minimum value = 0, maximum value = 10 Lower scores indicate better outcome (ie, less interference)
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. Baseline, Week 24 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.
Patient Global Impression of Change (PGIC) Scales at Weeks 12 and 24 of the Efficacy Treatment Period. Week 12 and Week 24 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".
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. Baseline, Week 4, Week 12, and Week 24 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)Safety of G-ER Measuring Columbia-Suicide Severity Rating Scale (C-SSRS). Week 4, Week 12, Week 24/Early Termination, Week 28 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.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. Baseline, Week 4, Week 12, and Week 24 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)).