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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Depomed
ClinicalTrials.gov Identifier:
NCT01080300
First received: March 2, 2010
Last updated: February 7, 2014
Last verified: November 2011
  Purpose

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


Condition Intervention Phase
Hot Flashes
Drug: Gabapentin Extended Release
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Depomed:

Primary Outcome Measures:
  • Evaluate Efficacy of 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. [ Time Frame: Baseline, Week 4, and Week 12 ] [ Designated as safety issue: No ]
    To assess the efficacy of 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.

  • Evaluate Efficacy of 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. [ Time Frame: Baseline, Week 4, and Week 12 ] [ Designated as safety issue: No ]
    To assess the efficacy of 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:
  • Evaluate Safety of G-ER [ Time Frame: 6mt treatment, 1mt f/u ] [ Designated as safety issue: Yes ]
    Evaluate safety of G-ER,change from average daily frequency & severity score of HFs from baseline to end point(wk 24),assess sleep interference, depression,suicidal ideation, quality of life, patient and investigator global impression of change


Enrollment: 600
Study Start Date: August 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gabapentin Extended Release
Active treatment
Drug: Gabapentin Extended Release
Gabapentin ER 1800mg daily
Placebo
Placebo
Drug: Placebo
Sugar pill

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01080300

  Show 66 Study Locations
Sponsors and Collaborators
Depomed
Investigators
Study Director: Rekha Sathyanarayana Depomed
  More Information

No publications provided by Depomed

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Depomed
ClinicalTrials.gov Identifier: NCT01080300     History of Changes
Other Study ID Numbers: 81-0064
Study First Received: March 2, 2010
Results First Received: November 13, 2013
Last Updated: February 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Depomed:
Hot Flushes
Vasomotor Symptoms
Menopausal Hot Flashes

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents

ClinicalTrials.gov processed this record on September 30, 2014