Phase 3 N=595 Randomized Quadruple-blind Treatment

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

Hot Flashes

Bottom Line

View on ClinicalTrials.gov: NCT01080300 ↗

Enrolled (actual)

595

Serious AEs

1.8%

Results posted

Mar 2014

Primary outcome: 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. — -6.72; -5.01; -7.64; -6.50 hot flashes — p=0.0003

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Gabapentin Extended Release (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Depomed
Primary completion: Sep 2011

Outcome Measures

Outcome	Result	p-value
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.	-6.72; -5.01; -7.64; -6.50	0.0003 sig
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.	-0.42; -0.22; -0.65; -0.46	<0.0001 sig
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.	-8.99; -7.91	0.1510
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.	-0.86; -0.64	0.0004 sig
SECONDARY Patient Global Impression of Change (PGIC) Scales at Weeks 12 and 24 of the Efficacy Treatment Period.	173; 130; 156; 114	0.0008 sig
SECONDARY Clinical Global Impression of Change (CGIC) Scales at Weeks 12 and 24 of the Efficacy Treatment Period.	173; 122; 159; 124	<0.0001 sig
SECONDARY Percent of Patients With 75% or Greater Reduction in Average Daily Frequency of Moderate to Severe Hot Flashes	125; 101; 146; 122	0.0609
SECONDARY Percent of Patients With 75% or Greater Reduction in Average Daily Severity Score of Moderate to Severe Hot Flashes	48; 36; 62; 48	0.1825
SECONDARY Change From Baseline to Weeks 4, Week 12, and Week 24 in Average Daily Sleep Interference Score.	-2.67; -1.31; -3.09; -2.17; -3.15; -2.20	<0.0001 sig
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.	-6.47; -4.13; -7.02; -5.17; -6.71; -4.95	<0.0001 sig
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.	-0.91; -0.71; -1.01; -0.87; -1.01; -0.96	0.0137 sig
SECONDARY Safety of G-ER Measuring Columbia-Suicide Severity Rating Scale (C-SSRS).	0; 0; 260; 257; 1; 0	—

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

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01080300). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.