Back to resultsBreeze3:Study of Gabapentin Extended Release in the Treatment of Vasomotor Symptoms(Hot Flashes)in Postmenopausal Women (Breeze3)
Primary Purpose
Hot Flashes
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Gabapentin Extended Release
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hot Flashes focused on measuring Hot Flushes, Vasomotor Symptoms, Menopausal Hot Flashes
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Gabapentin Extended Release
Placebo
Arm Description
Active treatment
Placebo
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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".
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".
Percent of Patients With 75% or Greater Reduction in Average Daily Frequency of Moderate to Severe Hot Flashes
Percent of Patients With 75% or Greater Reduction in Average Daily Severity Score of Moderate to Severe Hot Flashes
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)
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)).
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)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01080300
Brief Title
Breeze3:Study of Gabapentin Extended Release in the Treatment of Vasomotor Symptoms(Hot Flashes)in Postmenopausal Women
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Depomed
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hot Flashes
Keywords
Hot Flushes, Vasomotor Symptoms, Menopausal Hot Flashes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
600 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gabapentin Extended Release
Arm Type
Experimental
Arm Description
Active treatment
Arm Title
Placebo
Arm Type
Other
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Gabapentin Extended Release
Intervention Description
Gabapentin ER 1800mg daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Sugar pill
Primary Outcome Measure Information:
Title
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.
Description
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
Title
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.
Description
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
Secondary Outcome Measure Information:
Title
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.
Description
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
Title
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.
Description
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.
Time Frame
Baseline, Week 24
Title
Patient Global Impression of Change (PGIC) Scales at Weeks 12 and 24 of the Efficacy Treatment Period.
Description
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
Title
Clinical Global Impression of Change (CGIC) Scales at Weeks 12 and 24 of the Efficacy Treatment Period.
Description
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
Title
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
Title
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
Title
Change From Baseline to Weeks 4, Week 12, and Week 24 in Average Daily Sleep Interference Score.
Description
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
Title
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.
Description
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
Title
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.
Description
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
Title
Safety of G-ER Measuring Columbia-Suicide Severity Rating Scale (C-SSRS).
Description
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rekha Sathyanarayana
Organizational Affiliation
Depomed
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
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United States
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Mobile
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Alabama
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United States
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Phoenix
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Arizona
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Scottsdale
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Tucson
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Little Rock
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Berkeley
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Roseville
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San Diego
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Denver
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Colorado
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Danbury
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Connecticut
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Milford
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Connecticut
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Brooksville
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Florida
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Clearwater
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DeLand
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Gainesville
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Naples
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New Port Richey
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North Miami
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Orlando
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Decatur
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Georgia
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Idaho Falls
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Idaho
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Indianapolis
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Indiana
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South Bend
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Indiana
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Overland Park
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Louisville
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Kentucky
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New Orleans
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Louisiana
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Paw Paw
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Michigan
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Brooklyn Center
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Minnesota
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Las Vegas
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Nevada
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Reno
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Nevada
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Moorestown
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New Jersey
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Plainsboro
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New Jersey
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Albuquerque
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New Mexico
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Charlotte
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North Carolina
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New Bern
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Raleigh
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North Carolina
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Winston-Salem
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North Carolina
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Bismarck
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North Dakota
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United States
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Fargo
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North Dakota
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Akron
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Ohio
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United States
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Cincinnati
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Ohio
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United States
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Cleveland
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Ohio
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United States
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Columbus
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Ohio
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United States
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Kettering
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Ohio
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Oklahoma City
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Oklahoma
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Eugene
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Oregon
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United States
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Philadelphia
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Pennsylvania
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United States
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Pittsburgh
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Pennsylvania
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United States
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West Reading
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Pennsylvania
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United States
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Wexford
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Pennsylvania
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United States
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Warwick
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Rhode Island
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United States
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Anderson
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South Carolina
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United States
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Columbia
State/Province
South Carolina
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United States
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Goose Creek
State/Province
South Carolina
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United States
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Greer
State/Province
South Carolina
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Rapid City
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South Dakota
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United States
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Chattanooga
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Tennessee
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United States
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Nashville
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Tennessee
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Dallas
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Texas
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Lake Jackson
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Texas
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San Antonio
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Texas
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Salt Lake City
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Utah
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Charlottesville
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Virginia
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United States
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Richmond
State/Province
Virginia
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United States
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Seattle
State/Province
Washington
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24149930
Citation
Pinkerton JV, Kagan R, Portman D, Sathyanarayana R, Sweeney M; Breeze 3 Investigators. Phase 3 randomized controlled study of gastroretentive gabapentin for the treatment of moderate-to-severe hot flashes in menopause. Menopause. 2014 Jun;21(6):567-73. doi: 10.1097/GME.0b013e3182a7c073.
Results Reference
derived
Learn more about this trial
Breeze3:Study of Gabapentin Extended Release in the Treatment of Vasomotor Symptoms(Hot Flashes)in Postmenopausal Women
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