Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00511953
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2007-08-02
Brief Title:
Study of Gabapentin Extended Release G-ER in the Treatment of Vasomotor Hot FlashesHot Flushes Symptoms in Postmenopausal Women
Sponsor:
Depomed
Organization:
Depomed
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2011-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Depomeds 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None