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

Hot Flashes Clinical Trial

— Breeze3  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01080300
• Other study ID #: 81-0064
• Status: Completed
• Phase: Phase 3
• Start date: August 2010
• Est. completion date: September 2011

Study information

• Verified date: April 2020
• Source: Depomed
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hot Flashes

Intervention

Drug:
• Gabapentin Extended Release
Gabapentin ER 1800mg daily
• Placebo
Sugar pill

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Depomed

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Percent of Patients With 75% or Greater Reduction in Average Daily Frequency of Moderate to Severe Hot Flashes		Baseline, Week 12, and Week 24
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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