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

Hot Flashes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00511953
• Other study ID #: 81-0056
• Status: Completed
• Phase: Phase 2
• First received: August 2, 2007
• Last updated: June 6, 2011
• Start date: June 2007
• Est. completion date: February 2008

Study information

• Verified date: June 2011
• Source: Depomed
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: February 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Hot Flashes

Intervention

Drug:
• Gabapentin Extended Release tablets
1800mg
• Gabapentin
1800mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Depomed

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24hrs	Yes
Secondary	CGIC and PGIC evaluated prior to the start of 24- hour blood samples at week 6 and week 12 visits.	Efficacy variables	12 wks	Yes