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:	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 Drug: Gabapentin	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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 Gabapentin enacarbil

U.S. FDA Resources

Further study details as provided by Depomed:

Primary Outcome Measures:

Frequency of moderate to severe hot flashes reported during the corresponding 24- hour blood samples collection period [ Time Frame: 24hrs ] [ Designated as safety issue: Yes ]
PD end points are considered as primary outcomes of this study

Secondary Outcome Measures:

CGIC and PGIC evaluated prior to the start of 24- hour blood samples at week 6 and week 12 visits. [ Time Frame: 12 wks ] [ Designated as safety issue: Yes ]
Efficacy variables

Estimated Enrollment:	108
Study Start Date:	June 2007
Study Completion Date:	February 2008
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Gabapentin ER Active drug, Gabapentin extended release	Drug: Gabapentin Extended Release tablets 1800mg Drug: Gabapentin 1800mg
Placebo Comparator: Sugar Pill Comparator arm is Placebo	Drug: Gabapentin Extended Release tablets 1800mg Drug: Gabapentin 1800mg

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

Responsible Party:	Rekha Sathyanarayana, Depomed
ClinicalTrials.gov Identifier:	NCT00511953 History of Changes
Other Study ID Numbers:	81-0056
Study First Received:	August 2, 2007
Last Updated:	June 6, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Depomed:

Hot flashes
Hot flushes
Postmenopausal symptoms

Additional relevant MeSH terms:

Hot Flashes
Signs and Symptoms
Gabapentin
Gamma-Aminobutyric Acid
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
GABA Agents

ClinicalTrials.gov processed this record on February 09, 2012