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| Sponsor: | Depomed |
|---|---|
| Information provided by (Responsible Party): | Depomed |
| ClinicalTrials.gov Identifier: | NCT00777023 |
Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Hot Flashes |
Drug: Gabapentin Extended-Release (G-ER) 1200 mg Drug: Gabapentin Extended-Release (G-ER) 1800 mg Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety and Efficacy of Gabapentin Extended Release (G-ER) Tablets in the Treatment of Vasomotor Symptoms in Postmenopausal Women |
Mean change from baseline in average daily severity score of moderate or severe hot flashes at stable dose week (SDW) 4 of treatment relative to placebo; last observation carried forward (LOCF) analysis.
Severity of hot flashes is scored on a scale of 1 to 3 where 1=mild, 2=moderate, 3=severe.
Mean change from baseline in average daily severity score of moderate or severe hot flashes at stable dose week (SDW) 12 of treatment relative to placebo; last observation carried forward (LOCF) analysis.
Severity of hot flashes is scored on a scale of 1 to 3 where 1=mild, 2=moderate, 3=severe.
| Enrollment: | 565 |
| Study Start Date: | October 2008 |
| Study Completion Date: | October 2009 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: G-ER 1200 mg
Gabapentin extended-release (G-ER) 1200 mg
|
Drug: Gabapentin Extended-Release (G-ER) 1200 mg
G-ER 1200 mg daily dosage given as two 600-mg tablets.
Other Name: Gabapentin
|
|
Experimental: G-ER 1800 mg
Gabapentin extended-release (G-ER) 1800 mg
|
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.
Other Name: Gabapentin
|
|
Placebo Comparator: Sugar Pill
Placebo 1200 mg or 1800 mg
|
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).
Other Name: Placebo; sugar pill
|
The primary study objective is to assess the efficacy of G-ER dosed in either of the following regimens:
G-ER 1200mg daily (single evening dose)
G-ER 1800mg daily (dosed asymmetrically; 600mg AM/1200mg 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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Other Inclusions apply.
Exclusion Criteria:
Other Exclusions apply.
Contacts and Locations
Show 45 Study Locations
More Information
| Responsible Party: | Depomed |
| ClinicalTrials.gov Identifier: | NCT00777023 History of Changes |
| Other Study ID Numbers: | BREEZE 2, 81-0059 |
| Study First Received: | October 21, 2008 |
| Results First Received: | January 16, 2012 |
| Last Updated: | February 21, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
Hot Flashes Hot Flushes Postmenopausal symptoms Vasomotor symptoms |
|
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