Study of Gabapentin Extended Release (G-ER) in the Treatment of Vasomotor (Hot Flashes/Hot Flushes) Symptoms in Postmenopausal Women
Overview[ - collapse ][ - ]
| 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 | Hot Flashes |
| Intervention | Drug: Gabapentin Extended Release tablets Drug: Gabapentin |
| Phase | Phase 2 |
| Sponsor | Depomed |
| Responsible Party | Depomed |
| ClinicalTrials.gov Identifier | NCT00511953 |
| First Received | August 2, 2007 |
| Last Updated | June 6, 2011 |
| Last verified | June 2011 |
Tracking Information[ + expand ][ + ]
| First Received Date | August 2, 2007 |
|---|---|
| Last Updated Date | June 6, 2011 |
| Start Date | June 2007 |
| Estimated Primary Completion Date | February 2008 |
| Current Primary Outcome Measures | Frequency of moderate to severe hot flashes reported during the corresponding 24- hour blood samples collection period [Time Frame: 24hrs] [Designated as safety issue: Yes]PD end points are considered as primary outcomes of this study |
| Current Secondary Outcome Measures | CGIC and PGIC evaluated prior to the start of 24- hour blood samples at week 6 and week 12 visits. [Time Frame: 12 wks] [Designated as safety issue: Yes]Efficacy variables |
Descriptive Information[ + expand ][ + ]
| Brief Title | 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 |
| 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. |
| Study Type | Interventional |
| Study Phase | Phase 2 |
| Study Design | Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
| Condition | Hot Flashes |
| Intervention | Drug: Gabapentin Extended Release tablets 1800mg Drug: Gabapentin 1800mg |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 108 |
| Estimated Completion Date | February 2008 |
| Estimated Primary Completion Date | December 2007 |
| 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. |
| Gender | Female |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00511953 |
|---|---|
| Other Study ID Numbers | 81-0056 |
| Has Data Monitoring Committee | No |
| Information Provided By | Depomed |
| Study Sponsor | Depomed |
| Collaborators | Not Provided |
| Investigators | Not Provided |
| Verification Date | June 2011 |
Locations[ + expand ][ + ]
| United States, California | Burbank, California, United States |
|---|---|
| United States, Florida | DeLand, Florida, United States |
| United States, Florida | Port Orange, Florida, United States |
| United States, Kansas | Shawnee, Kansas, United States |
| United States, Maryland | Baltimore, Maryland, United States |
| United States, New Jersey | Hackensack, New Jersey, United States |
| United States, South Carolina | Greenville, South Carolina, United States |
| United States, Texas | San Antonio, Texas, United States |