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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
600
Gabapentin ER 1800mg daily
Sugar pill
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.
Time frame: 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.
Time frame: Baseline, Week 4, and Week 12
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.
Time frame: 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.
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Birmingham, Alabama, United States
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Mobile, Alabama, United States
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Phoenix, Arizona, United States
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Scottsdale, Arizona, United States
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Tucson, Arizona, United States
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Little Rock, Arkansas, United States
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Berkeley, California, United States
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Roseville, California, United States
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San Diego, California, United States
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Denver, Colorado, United States
...and 56 more locations
Time frame: 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".
Time frame: 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".
Time frame: Week 12 and Week 24
Percent of Patients With 75% or Greater Reduction in Average Daily Frequency of Moderate to Severe Hot Flashes
Time frame: 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
Time frame: 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)
Time frame: 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)).
Time frame: 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)
Time frame: 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.
Time frame: Week 4, Week 12, Week 24/Early Termination, Week 28