Clinical trial NCT01080300: Breeze3:Study of Gabapentin Extended Release in the Treatment of Vasomotor Symptoms(Hot Flashes)in Postmenopausal Women
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hot Flashes
Keywords: Hot Flushes
Vasomotor Symptoms
Menopausal Hot Flashes
Lead sponsor: Depomed
Sponsor class: INDUSTRY
First posted: 2010-03-04
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 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.
timeFrame: Baseline, Week 4, and Week 12
measure: 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.
timeFrame: Baseline, Week 4, and Week 12
Secondary outcomes:
measure: 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.
timeFrame: Baseline, Week 24
measure: 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.
timeFrame: Baseline, Week 24
measure: Patient Global Impression of Change (PGIC) Scales at Weeks 12 and 24 of the Efficacy Treatment Period.
timeFrame: Week 12 and Week 24
measure: Clinical Global Impression of Change (CGIC) Scales at Weeks 12 and 24 of the Efficacy Treatment Period.
timeFrame: Week 12 and Week 24
measure: Percent of Patients With 75% or Greater Reduction in Average Daily Frequency of Moderate to Severe Hot Flashes
timeFrame: Baseline, Week 12, and Week 24
measure: Percent of Patients With 75% or Greater Reduction in Average Daily Severity Score of Moderate to Severe Hot Flashes
timeFrame: Baseline, Week 12, and Week 24
measure: Change From Baseline to Weeks 4, Week 12, and Week 24 in Average Daily Sleep Interference Score.
timeFrame: Baseline, Week 4, Week 12, and Week 24
measure: 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.
timeFrame: Baseline, Week 4, Week 12, and Week 24
measure: 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.
timeFrame: Baseline, Week 4, Week 12, and Week 24
measure: Safety of G-ER Measuring Columbia-Suicide Severity Rating Scale (C-SSRS).
timeFrame: Week 4, Week 12, Week 24/Early Termination, Week 28
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Mobile
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Scottsdale
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Berkeley
country: United States
state: California
city: Roseville
country: United States
state: California
city: San Diego
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Danbury
country: United States
state: Connecticut
city: Milford
country: United States
state: Connecticut
city: Brooksville
country: United States
state: Florida
city: Clearwater
country: United States
state: Florida
city: DeLand
country: United States
state: Florida
city: Gainesville
country: United States
state: Florida
city: Naples
country: United States
state: Florida
city: New Port Richey
country: United States
state: Florida
city: North Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Decatur
country: United States
state: Georgia
city: Idaho Falls
country: United States
state: Idaho
city: Indianapolis
country: United States
state: Indiana
city: South Bend
country: United States
state: Indiana
city: Overland Park
country: United States
state: Kansas
city: Louisville
country: United States
state: Kentucky
city: New Orleans
country: United States
state: Louisiana
city: Paw Paw
country: United States
state: Michigan
city: Brooklyn Center
country: United States
state: Minnesota
city: Las Vegas
country: United States
state: Nevada
city: Reno
country: United States
state: Nevada
city: Moorestown
country: United States
state: New Jersey
city: Plainsboro
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Charlotte
country: United States
state: North Carolina
city: New Bern
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Bismarck
country: United States
state: North Dakota
city: Fargo
country: United States
state: North Dakota
city: Akron
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Kettering
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Eugene
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: West Reading
country: United States
state: Pennsylvania
city: Wexford
country: United States
state: Pennsylvania
city: Warwick
country: United States
state: Rhode Island
city: Anderson
country: United States
state: South Carolina
city: Columbia
country: United States
state: South Carolina
city: Goose Creek
country: United States
state: South Carolina
city: Greer
country: United States
state: South Carolina
city: Rapid City
country: United States
state: South Dakota
city: Chattanooga
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Lake Jackson
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Charlottesville
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
Study officials:
affiliation: Depomed
name: Rekha Sathyanarayana
role: STUDY_DIRECTOR
References:
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.