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

This study has been completed.

First Received: August 2, 2007 Last Updated: July 1, 2008 History of Changes

Sponsor:	Depomed
Information provided by:	Depomed
ClinicalTrials.gov Identifier:	NCT00511953

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 Extended Release tablets	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Pharmacokinetics/Dynamics Study
Official Title:	A Phase 2, Multicenter, Randomized, Double-Blind, Placebo Controlled Study of the Pharmacokinetics (PK) and Pharmacodynamics (PD) 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

U.S. FDA Resources

Further study details as provided by Depomed:

Estimated Enrollment:	108
Study Start Date:	May 2007

Detailed Description:

The primary objective of this clinical trial is to determine the optimal dose of Gabapentin ER in reducing the number and severity of hot flashes in postmenopausal women. Patients will be randomly assigned to Gabapentin ER or placebo, with a 1 in 4 chance of getting placebo. The total study investigational treatment duration after screening and baseline will be 13 weeks. The primary endpoint of the trial is to compare the number and severity of hot flashes during the investigational treatment compared to baseline. Sleep quality will also be evaluated.

Eligibility

Ages Eligible for Study:	18 Years and older
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.
Patient must be willing to commit to 3 (optionally 4) overnight stays at the study site that will include frequent blood sampling.

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: NCT00511953

Locations

United States, California

Burbank, California, United States
United States, Florida

DeLand, Florida, United States

Port Orange, Florida, United States
United States, Kansas

Shawnee, Kansas, United States
United States, Maryland

Baltimore, Maryland, United States
United States, New Jersey

Hackensack, New Jersey, United States
United States, South Carolina

Greenville, South Carolina, United States
United States, Texas

San Antonio, Texas, United States

Sponsors and Collaborators

Depomed

More Information

No publications provided

Study ID Numbers:	81-0056
Study First Received:	August 2, 2007
Last Updated:	July 1, 2008
ClinicalTrials.gov Identifier:	NCT00511953 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Depomed:

Hot flashes
Hot flushes
Postmenopausal symptoms

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Gabapentin
Physiological Effects of Drugs
Hot Flashes
Psychotropic Drugs
Antiparkinson Agents
Calcium Channel Blockers
Excitatory Amino Acid Agents
Membrane Transport Modulators
Signs and Symptoms
Sensory System Agents

Therapeutic Uses
Analgesics
Excitatory Amino Acid Antagonists
Tranquilizing Agents
Central Nervous System Depressants
Cardiovascular Agents
Antimanic Agents
Pharmacologic Actions
Anti-Anxiety Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on February 08, 2010