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

PHASE3CompletedINTERVENTIONAL
Enrollment

541

Participants

Timeline

Start Date

September 30, 2008

Primary Completion Date

August 31, 2009

Study Completion Date

October 31, 2009

Conditions
Hot Flashes
Interventions
DRUG

Gabapentin Extended-Release (G-ER) 1200 mg

G-ER 1200 mg daily dosage given as two 600-mg tablets.

DRUG

Gabapentin Extended-Release (G-ER) 1800 mg

G-ER 1800 mg daily dosage given as one 600-mg tablet in the morning and two 600-mg tablets in the evening.

DRUG

Placebo

Matching placebo dosages of 1200 mg daily (two 600-mg tablets) and 1800 mg daily (one 600-mg tablet in the morning and two 600-mg tablets in the evening).

Trial Locations (45)

Unknown

Birmingham

Montgomery

Tempe

Tucson

Berkely

La Mesa

San Diego

Santa Rosa

Denver

Lakewood

Waterbury

Washington D.C.

Clearwater

Jacksonville

New Port Richey

Orlando

St. Petersburg

Tampa

Atlanta

Sandy Springs

Savannah

Chicago

Madisonville

Fall River

Edina

St Louis

Billings

Las Vegas

Moorestown

Raleigh

Wilmington

Fargo

Columbus

Pittsburgh

West Reading

Columbia

Hilton Head Island

Nashville

Dallas

Houston

San Antonio

Salt Lake City

Bellevue

Renton

Spokane

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Depomed

INDUSTRY

NCT00755417 - Study of Gabapentin Extended Release (G-ER) in the Treatment of Vasomotor (Hot Flashes/Hot Flushes) Symptoms in Postmenopausal Women | Biotech Hunter | Biotech Hunter