Study of Gabapentin Extended Release (G-ER) in the Treatment of Vasomotor (Hot Flashes/Hot Flushes) Symptoms in Postmenopausal Women
This study has been completed.
Sponsor:
Depomed
Information provided by (Responsible Party):
Depomed
ClinicalTrials.gov Identifier:
NCT00755417
First received: September 17, 2008
Last updated: February 3, 2012
Last verified: February 2012
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Tracking Information | |
---|---|
First Received Date ICMJE | September 17, 2008 |
Last Updated Date | February 3, 2012 |
Start Date ICMJE | September 2008 |
Primary Completion Date | August 2009 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE |
|
Original Primary Outcome Measures ICMJE |
Reduction of frequency and severity of hot flashes after 24 weeks of treatment with a stable dose relative to placebo, compared with the baseline week. [ Time Frame: At 4 and 12 weeks of treatment ] [ Designated as safety issue: No ] |
Change History | Complete list of historical versions of study NCT00755417 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE | |
Original Secondary Outcome Measures ICMJE | |
Current Other Outcome Measures ICMJE | |
Original Other Outcome Measures ICMJE | |
Descriptive Information | |
Brief Title ICMJE | Study of Gabapentin Extended Release (G-ER) in the Treatment of Vasomotor (Hot Flashes/Hot Flushes) Symptoms in Postmenopausal Women |
Official Title ICMJE | 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 |
Brief 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. |
Detailed Description | The primary study objective is to assess the efficacy of G-ER dosed in either of the following regimens:
|
Study Type ICMJE | Interventional |
Study Phase | Phase 3 |
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
Condition ICMJE | Hot Flashes |
Intervention ICMJE |
|
Study Arm (s) |
|
Publications * | |
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|
Recruitment Information | |
Recruitment Status ICMJE | Completed |
Enrollment ICMJE | 541 |
Completion Date | October 2009 |
Primary Completion Date | August 2009 (final data collection date for primary outcome measure) |
Eligibility Criteria ICMJE | Inclusion Criteria:
Other Inclusions apply. Exclusion Criteria:
Other Exclusions apply. |
Gender | Female |
Ages | 18 Years to 70 Years |
Accepts Healthy Volunteers | No |
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
Location Countries ICMJE | United States |
Administrative Information | |
NCT Number ICMJE | NCT00755417 |
Other Study ID Numbers ICMJE | BREEZE 1, 81-0058 |
Has Data Monitoring Committee | No |
Responsible Party | Depomed |
Study Sponsor ICMJE | Depomed |
Collaborators ICMJE | |
Investigators ICMJE | |
Information Provided By | Depomed |
Verification Date | February 2012 |
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |