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Clinical Trial Summary

Depomed's Gabapentin Extended Release (G-ER) is an investigational, extended release formulation of gabapentin that is being studied for the treatment of hot flashes in postmenopausal women.


Clinical Trial Description

The primary study objective is to assess the efficacy of G-ER dosed in either of the following regimens:

- G-ER 1200 mg daily (single evening dose)

- G-ER 1800 mg daily (dosed asymmetrically; 600 mg in AM/1200 mg in PM) compared to placebo in reducing the average daily frequency and severity score of moderate to severe hot flashes in postmenopausal women after 4 weeks and 12 weeks of treatment with a stable dose, compared with the baseline week. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00755417
Study type Interventional
Source Depomed
Contact
Status Completed
Phase Phase 3
Start date September 2008
Completion date October 2009

See also
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