search
Back to results

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

Primary Purpose

Hot Flashes

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Gabapentin Extended Release tablets
Gabapentin
Sponsored by
Depomed
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hot Flashes focused on measuring Hot flashes, Hot flushes, Postmenopausal symptoms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Gabapentin ER

Sugar Pill

Arm Description

Active drug, Gabapentin extended release

Comparator arm is Placebo

Outcomes

Primary Outcome Measures

Frequency of moderate to severe hot flashes reported during the corresponding 24- hour blood samples collection period
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.
Efficacy variables

Full Information

First Posted
August 2, 2007
Last Updated
June 6, 2011
Sponsor
Depomed
search

1. Study Identification

Unique Protocol Identification Number
NCT00511953
Brief Title
Study of Gabapentin Extended Release (G-ER) in the Treatment of Vasomotor (Hot Flashes/Hot Flushes) Symptoms in Postmenopausal Women
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Depomed

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hot Flashes
Keywords
Hot flashes, Hot flushes, Postmenopausal symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gabapentin ER
Arm Type
Active Comparator
Arm Description
Active drug, Gabapentin extended release
Arm Title
Sugar Pill
Arm Type
Placebo Comparator
Arm Description
Comparator arm is Placebo
Intervention Type
Drug
Intervention Name(s)
Gabapentin Extended Release tablets
Intervention Description
1800mg
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Intervention Description
1800mg
Primary Outcome Measure Information:
Title
Frequency of moderate to severe hot flashes reported during the corresponding 24- hour blood samples collection period
Description
PD end points are considered as primary outcomes of this study
Time Frame
24hrs
Secondary Outcome Measure Information:
Title
CGIC and PGIC evaluated prior to the start of 24- hour blood samples at week 6 and week 12 visits.
Description
Efficacy variables
Time Frame
12 wks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
City
Burbank
State/Province
California
Country
United States
City
DeLand
State/Province
Florida
Country
United States
City
Port Orange
State/Province
Florida
Country
United States
City
Shawnee
State/Province
Kansas
Country
United States
City
Baltimore
State/Province
Maryland
Country
United States
City
Hackensack
State/Province
New Jersey
Country
United States
City
Greenville
State/Province
South Carolina
Country
United States
City
San Antonio
State/Province
Texas
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22775354
Citation
Cowles VE, Gordi T, Hou SY. Steady-state pharmacokinetics of gabapentin after administration of a novel gastroretentive extended-release formulation in postmenopausal women with vasomotor symptoms. Clin Drug Investig. 2012 Sep 1;32(9):593-601. doi: 10.1007/BF03261914.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs