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:
Depomed
ClinicalTrials.gov Identifier:
NCT00511953
First received: August 2, 2007
Last updated: June 6, 2011
Last verified: June 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 tablets Drug: Gabapentin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Depomed:
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
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
| Estimated Enrollment: | 108 |
| Study Start Date: | June 2007 |
| Study Completion Date: | February 2008 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Gabapentin ER
Active drug, Gabapentin extended release
|
Drug: Gabapentin Extended Release tablets
1800mg
Drug: Gabapentin
1800mg
|
|
Placebo Comparator: Sugar Pill
Comparator arm is Placebo
|
Drug: Gabapentin Extended Release tablets
1800mg
Drug: Gabapentin
1800mg
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Generally healthy, postmenopausal women who seek treatment for hot flashes.
- Patients using hormone replacement therapy (HRT) must be willing to discontinue treatment.
- Patients must be experiencing at least 7 moderate to severe hot flashes per day.
- 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:
- Patients with hypersensitivity to gabapentin.
- Patients with severe chronic diarrhea, chronic constipation, uncontrolled irritable bowel syndrome (IBS) or unexplained weight loss.
- Patients treated with estrogen pellets or injectable progestin drug therapy within 6 months.
Other exclusions apply.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00511953
Locations
| United States, California | |
| Burbank, California, United States | |
| United States, Florida | |
| DeLand, Florida, United States | |
| 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 | |
Sponsors and Collaborators
Depomed
More Information
No publications provided by Depomed
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Rekha Sathyanarayana, Depomed |
| ClinicalTrials.gov Identifier: | NCT00511953 History of Changes |
| Other Study ID Numbers: | 81-0056 |
| Study First Received: | August 2, 2007 |
| Last Updated: | June 6, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Depomed:
|
Hot flashes Hot flushes Postmenopausal symptoms |
Additional relevant MeSH terms:
|
Hot Flashes Signs and Symptoms Gabapentin Gamma-Aminobutyric Acid Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anticonvulsants Antiparkinson Agents Anti-Dyskinesia Agents |
Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Antimanic Agents GABA Agents |
ClinicalTrials.gov processed this record on May 23, 2013