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

Phase 2

Completed

• Conditions: Hot Flashes
• Interventions: Drug: Gabapentin Extended Release tablets; Drug: Gabapentin

• Registration Number: NCT00511953
• Lead Sponsor: Depomed

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.

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-08-02
• Study First Submitted QC: 2007-08-02
• Study First Posted: 2007-08-06
• Primary Completion: 2007-12
• Study Completion: 2008-02
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-06
• Last Update Posted: 2011-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 108

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Gabapentin ER	Gabapentin Extended Release tablets	Active drug, Gabapentin extended release
Gabapentin ER	Gabapentin	Active drug, Gabapentin extended release
Sugar Pill	Gabapentin Extended Release tablets	Comparator arm is Placebo
Sugar Pill	Gabapentin	Comparator arm is Placebo

Primary Outcome Measures

Name	Time	Method
Frequency of moderate to severe hot flashes reported during the corresponding 24- hour blood samples collection period	24hrs	PD end points are considered as primary outcomes of this study

Secondary Outcome Measures

Name	Time	Method
CGIC and PGIC evaluated prior to the start of 24- hour blood samples at week 6 and week 12 visits.	12 wks	Efficacy variables