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

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

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

Study Overview

• Status: Completed
• Conditions: Hot Flashes
• Intervention / Treatment: Drug: Placebo; Drug: Gabapentin Extended Release

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.

• Study Type: Interventional
• Enrollment (Actual): 600
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States
    • Mobile, Alabama, United States
  • Arizona
    • Phoenix, Arizona, United States
    • Scottsdale, Arizona, United States
    • Tucson, Arizona, United States
  • Arkansas
    • Little Rock, Arkansas, United States
  • California
    • Berkeley, California, United States
    • Roseville, California, United States
    • San Diego, California, United States
  • Colorado
    • Denver, Colorado, United States
  • Connecticut
    • Danbury, Connecticut, United States
    • Milford, Connecticut, United States
  • Florida
    • Brooksville, Florida, United States
    • Clearwater, Florida, United States
    • DeLand, Florida, United States
    • Gainesville, Florida, United States
    • Naples, Florida, United States
    • New Port Richey, Florida, United States
    • North Miami, Florida, United States
    • Orlando, Florida, United States
  • Georgia
    • Decatur, Georgia, United States
  • Idaho
    • Idaho Falls, Idaho, United States
  • Indiana
    • Indianapolis, Indiana, United States
    • South Bend, Indiana, United States
  • Kansas
    • Overland Park, Kansas, United States
  • Kentucky
    • Louisville, Kentucky, United States
  • Louisiana
    • New Orleans, Louisiana, United States
  • Michigan
    • Paw Paw, Michigan, United States
  • Minnesota
    • Brooklyn Center, Minnesota, United States
  • Nevada
    • Las Vegas, Nevada, United States
    • Reno, Nevada, United States
  • New Jersey
    • Moorestown, New Jersey, United States
    • Plainsboro, New Jersey, United States
  • New Mexico
    • Albuquerque, New Mexico, United States
  • North Carolina
    • Charlotte, North Carolina, United States
    • New Bern, North Carolina, United States
    • Raleigh, North Carolina, United States
    • Winston-Salem, North Carolina, United States
  • North Dakota
    • Bismarck, North Dakota, United States
    • Fargo, North Dakota, United States
  • Ohio
    • Akron, Ohio, United States
    • Cincinnati, Ohio, United States
    • Cleveland, Ohio, United States
    • Columbus, Ohio, United States
    • Kettering, Ohio, United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States
  • Oregon
    • Eugene, Oregon, United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States
    • Pittsburgh, Pennsylvania, United States
    • West Reading, Pennsylvania, United States
    • Wexford, Pennsylvania, United States
  • Rhode Island
    • Warwick, Rhode Island, United States
  • South Carolina
    • Anderson, South Carolina, United States
    • Columbia, South Carolina, United States
    • Goose Creek, South Carolina, United States
    • Greer, South Carolina, United States
  • South Dakota
    • Rapid City, South Dakota, United States
  • Tennessee
    • Chattanooga, Tennessee, United States
    • Nashville, Tennessee, United States
  • Texas
    • Dallas, Texas, United States
    • Lake Jackson, Texas, United States
    • San Antonio, Texas, United States
  • Utah
    • Salt Lake City, Utah, United States
  • Virginia
    • Charlottesville, Virginia, United States
    • Richmond, Virginia, United States
  • Washington
    • Seattle, Washington, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Placebo	Drug: Placebo; Sugar pill
Experimental: Gabapentin Extended Release; Active treatment	Drug: Gabapentin Extended Release; Gabapentin ER 1800mg daily

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Depomed
• Investigators: Study Director: Rekha Sathyanarayana, Depomed

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: March 2, 2010
• First Submitted That Met QC Criteria: March 3, 2010
• First Posted (Estimate): March 4, 2010

Study Record Updates

• Last Update Posted (Actual): May 1, 2020
• Last Update Submitted That Met QC Criteria: April 21, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Vasomotor Symptoms; Hot Flushes; Menopausal Hot Flashes
• Additional Relevant MeSH Terms: Hot Flashes; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Tranquilizing Agents; Psychotropic Drugs; Anti-Anxiety Agents; Anticonvulsants; Antimanic Agents; Gabapentin
• Other Study ID Numbers: 81-0064