Study of Gabapentin Extended Release (G-ER)in the Treatment of Vasomotor (Hot Flashes/Hot Flushes) Symptoms in Postmenopausal Women. - Full Text View

Sponsor:	Depomed
Information provided by:	Depomed
ClinicalTrials.gov Identifier:	NCT00777023

Purpose

Depomed's Gabapentin Extended Release is an investigational, extended release formulation of gabapentin that is being studied for the treatment of hot flashes in postmenopausal women

Condition	Intervention	Phase
Hot Flashes	Drug: Gabapentin	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator) 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:

Drug Information available for: Gabapentin Gabapentin enacarbil

U.S. FDA Resources

Further study details as provided by Depomed:

Primary Outcome Measures:

Reduction of frequency and severity of hot flashes after 12 weeks of treatment with a stable dose relative to placebo, compared with the baseline week. [ Time Frame: At 4 and 12 weeks of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	540
Study Start Date:	October 2008
Study Completion Date:	October 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: Gabapentin
Experimental: 2	Drug: Gabapentin

Detailed Description:

The primary study objective is to assess the efficacy of G-ER dosed in either of the following regimens:

G-ER 1200mg daily (single evening dose)

G-ER 1800mg daily (dosed asymmetrically; 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 after 4 weeks and 12 weeks of treatment with a stable dose, compared with the baseline week.

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 at least 7 moderate to severe hot flashes per day.

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.

Other Exclusions apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00777023

Locations

United States, Alabama

Birmingham, Alabama, United States
United States, Arizona

Scottsdale, Arizona, United States
United States, Connecticut

Danbury, Connecticut, United States

Milford, Connecticut, United States
United States, Florida

Gainsville, Florida, United States

Pinellas Park, Florida, United States
United States, Georgia

Atlanta, Georgia, United States
United States, Indiana

Indianapolis, Indiana, United States
United States, Ohio

Cincinnati, Ohio, United States

Cleaveland, Ohio, United States
United States, Oregon

Medford, Oregon, United States
United States, Pennsylvania

Jenkintown, Pennsylvania, United States
United States, Texas

Dallas, Texas, United States
United States, Utah

West Jordan, Utah, United States

Sponsors and Collaborators

Depomed

More Information

No publications provided

Responsible Party:	Clinical Operations, Depomed
ClinicalTrials.gov Identifier:	NCT00777023 History of Changes
Other Study ID Numbers:	BREEZE 2, 81-0059
Study First Received:	October 21, 2008
Last Updated:	November 2, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Depomed:

Hot Flashes
Hot Flushes
Postmenopausal symptoms
Vasomotor symptoms

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 February 09, 2012