Breeze3:Study of Gabapentin Extended Release in the Treatment of Vasomotor Symptoms(Hot Flashes)in Postmenopausal Women
This study has been completed.
Sponsor:
Depomed
Information provided by (Responsible Party):
Depomed
ClinicalTrials.gov Identifier:
NCT01080300
First received: March 2, 2010
Last updated: November 1, 2011
Last verified: November 2011
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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 |
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 at Weeks 4 & 12 of the efficacy treatment period, compared with baseline. [ Time Frame: 6mt treatment, 1 mt f/u ] [ 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 & severity score of moderate to severe HFs in post menopausal women at weeks 4 & 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: Gabapentin Extended Release
Gabapentin ER 1800mg daily
|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01080300
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Hide Study LocationsLocations
| United States, Alabama | |
| Birmingham, Alabama, United States | |
| Mobile, Alabama, United States | |
| United States, Arizona | |
| Phoenix, Arizona, United States | |
| Scottsdale, Arizona, United States | |
| Tucson, Arizona, United States | |
| United States, Arkansas | |
| Little Rock, Arkansas, United States | |
| United States, California | |
| Berkeley, California, United States | |
| Roseville, California, United States | |
| San Diego, California, United States | |
| United States, Colorado | |
| Denver, Colorado, United States | |
| United States, Connecticut | |
| Danbury, Connecticut, United States | |
| Milford, Connecticut, United States | |
| 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 | |
| United States, Georgia | |
| Decatur, Georgia, United States | |
| United States, Idaho | |
| Idaho Falls, Idaho, United States | |
| United States, Indiana | |
| Indianapolis, Indiana, United States | |
| South Bend, Indiana, United States | |
| United States, Kansas | |
| Overland Park, Kansas, United States | |
| United States, Kentucky | |
| Louisville, Kentucky, United States | |
| United States, Louisiana | |
| New Orleans, Louisiana, United States | |
| United States, Michigan | |
| Paw Paw, Michigan, United States | |
| United States, Minnesota | |
| Brooklyn Center, Minnesota, United States | |
| United States, Nevada | |
| Las Vegas, Nevada, United States | |
| Reno, Nevada, United States | |
| United States, New Jersey | |
| Moorestown, New Jersey, United States | |
| Plainsboro, New Jersey, United States | |
| United States, New Mexico | |
| Albuquerque, New Mexico, United States | |
| 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 | |
| United States, North Dakota | |
| Bismarck, North Dakota, United States | |
| Fargo, North Dakota, United States | |
| United States, Ohio | |
| Akron, Ohio, United States | |
| Cincinnati, Ohio, United States | |
| Cleveland, Ohio, United States | |
| Columbus, Ohio, United States | |
| Kettering, Ohio, United States | |
| United States, Oklahoma | |
| Oklahoma City, Oklahoma, United States | |
| United States, Oregon | |
| Eugene, Oregon, United States | |
| United States, Pennsylvania | |
| Philadelphia, Pennsylvania, United States | |
| Pittsburgh, Pennsylvania, United States | |
| West Reading, Pennsylvania, United States | |
| Wexford, Pennsylvania, United States | |
| United States, Rhode Island | |
| Warwick, Rhode Island, United States | |
| 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 | |
| United States, South Dakota | |
| Rapid City, South Dakota, United States | |
| United States, Tennessee | |
| Chattanooga, Tennessee, United States | |
| Nashville, Tennessee, United States | |
| United States, Texas | |
| Dallas, Texas, United States | |
| Lake Jackson, Texas, United States | |
| San Antonio, Texas, United States | |
| United States, Utah | |
| Salt Lake City, Utah, United States | |
| United States, Virginia | |
| Charlottesville, Virginia, United States | |
| Richmond, Virginia, United States | |
| United States, Washington | |
| Seattle, Washington, United States | |
Sponsors and Collaborators
Depomed
Investigators
| Study Director: | Rekha Sathyanarayana | Depomed |
More Information
No publications provided
| Responsible Party: | Depomed |
| ClinicalTrials.gov Identifier: | NCT01080300 History of Changes |
| Other Study ID Numbers: | 81-0064 |
| Study First Received: | March 2, 2010 |
| Last Updated: | November 1, 2011 |
| 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 May 16, 2013