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

NCT01080300 | Completed Phase 3 Results

• 1 other identifier: 81-0064
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 66

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

Conditions

Hot Flashes

Keywords

Hot Flushes; Vasomotor Symptoms; Menopausal Hot Flashes

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• 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 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

• Patient Global Impression of Change (PGIC) Scales at Weeks 12 and 24 of the Efficacy Treatment Period.

  Week 12 and Week 24

• Clinical Global Impression of Change (CGIC) Scales at Weeks 12 and 24 of the Efficacy Treatment Period.

  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

Study Arms (2)

Gabapentin Extended Release

EXPERIMENTAL

Active treatment

Drug: Gabapentin Extended Release

Placebo

OTHER

Placebo

Drug: Placebo

Interventions

Gabapentin Extended Release DRUG

Gabapentin ER 1800mg daily

Gabapentin Extended Release

Placebo DRUG

Sugar pill

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Depomed: lead

Study Sites (66)

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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

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Danbury, Connecticut, United States

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Milford, Connecticut, United States

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Brooksville, Florida, United States

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Clearwater, Florida, United States

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DeLand, Florida, United States

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Gainesville, Florida, United States

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Naples, Florida, United States

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New Port Richey, Florida, United States

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North Miami, Florida, United States

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Orlando, Florida, United States

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Decatur, Georgia, United States

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Idaho Falls, Idaho, United States

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Indianapolis, Indiana, United States

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South Bend, Indiana, United States

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Overland Park, Kansas, United States

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Louisville, Kentucky, United States

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New Orleans, Louisiana, United States

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Paw Paw, Michigan, United States

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Brooklyn Center, Minnesota, United States

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Las Vegas, Nevada, United States

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Reno, Nevada, United States

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Moorestown, New Jersey, United States

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Plainsboro, New Jersey, United States

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Albuquerque, New Mexico, United States

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Charlotte, North Carolina, United States

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New Bern, North Carolina, United States

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Raleigh, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Bismarck, North Dakota, United States

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Fargo, North Dakota, United States

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Akron, Ohio, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Kettering, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Eugene, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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West Reading, Pennsylvania, United States

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Wexford, Pennsylvania, United States

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Warwick, Rhode Island, United States

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Anderson, South Carolina, United States

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Columbia, South Carolina, United States

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Goose Creek, South Carolina, United States

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Greer, South Carolina, United States

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Rapid City, South Dakota, United States

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Chattanooga, Tennessee, United States

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Nashville, Tennessee, United States

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Dallas, Texas, United States

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Lake Jackson, Texas, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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Charlottesville, Virginia, United States

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Richmond, Virginia, United States

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Seattle, Washington, United States

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Related Publications (1)

• 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.

  PMID: 24149930 DERIVED

MeSH Terms

Conditions

Hot Flashes

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Head of R&D
• Organization: Depomed

msweeney@depomed.com

510-744-8000

Study Officials

• Rekha Sathyanarayana

  Depomed

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2010
• First Posted: March 4, 2010
• Study Start: August 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: May 1, 2020
• Results First Posted: March 26, 2014

Record last verified: 2020-04

Locations

US (66)