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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.
Sponsor:
Information provided by:
Depomed
ClinicalTrials.gov Identifier:
NCT00511953
First received: August 2, 2007
Last updated: June 6, 2011
Last verified: June 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 in postmenopausal women.


Condition Intervention Phase
Hot Flashes
Drug: Gabapentin Extended Release tablets
Drug: Gabapentin
Phase 2

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:


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:

  1. Generally healthy, postmenopausal women who seek treatment for hot flashes.
  2. Patients using hormone replacement therapy (HRT) must be willing to discontinue treatment.
  3. Patients must be experiencing at least 7 moderate to severe hot flashes per day.
  4. 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:

  1. Patients with hypersensitivity to gabapentin.
  2. Patients with severe chronic diarrhea, chronic constipation, uncontrolled irritable bowel syndrome (IBS) or unexplained weight loss.
  3. Patients treated with estrogen pellets or injectable progestin drug therapy within 6 months.

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: 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 by Depomed

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Anti-Anxiety Agents
Anti-Dyskinesia Agents
Anticonvulsants
Antimanic Agents
Antiparkinson Agents
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
GABA Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 25, 2014