Clinical trial NCT00511953: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hot Flashes
Keywords: Hot flashes
Hot flushes
Postmenopausal symptoms
Lead sponsor: Depomed
Sponsor class: INDUSTRY
First posted: 2007-08-06
Enrollment: 108
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Frequency of moderate to severe hot flashes reported during the corresponding 24- hour blood samples collection period
timeFrame: 24hrs
Secondary outcomes:
measure: CGIC and PGIC evaluated prior to the start of 24- hour blood samples at week 6 and week 12 visits.
timeFrame: 12 wks
Other outcomes:
Locations:
city: Burbank
country: United States
state: California
city: DeLand
country: United States
state: Florida
city: Port Orange
country: United States
state: Florida
city: Shawnee
country: United States
state: Kansas
city: Baltimore
country: United States
state: Maryland
city: Hackensack
country: United States
state: New Jersey
city: Greenville
country: United States
state: South Carolina
city: San Antonio
country: United States
state: Texas
Study officials:
References:
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.