Not Signed In -
Nalmefene |
Revex |
Clinical Trial: Nalmefene Gambling Study
This study is currently recruiting patients.
Verified by Somaxon Pharmaceuticals August 2005
|
Purpose
To determine if nalmefene is safe and effective in the treatment of pathological gambling.
| Condition | Intervention | Phase |
|---|---|---|
| Pathological Gambling | Drug: nalmefene HCl | Phase II Phase III |
MedlinePlus related topics: Mental Health
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of Nalmefene HCl in the Treatment of Pathological Gambling
Further Study Details:
Primary Outcomes: Assess efficacy in treatment of pathological gambling
Secondary Outcomes: Evaluate safety and tolerability in treatment of pathological gambling.
Expected Total Enrollment: 225
Secondary Outcomes: Evaluate safety and tolerability in treatment of pathological gambling.
Expected Total Enrollment: 225
Study start: August 2005; Expected completion: September 2006
Last follow-up: May 2006; Data entry closure: July 2006
Randomized, double-blind, placebo-controlled, parallel-group, multi-centered, outpatient study to assess the efficacy, safety and tolerability of two doses of nalmefene in patients with current diagnosis of pathological gambling.
Eligibility
Ages Eligible for Study: 18 Years - 70 Years, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Current diagnosis of pathological gambling as defined by DSM-IV-TR
Exclusion Criteria:
-
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00132119
Philip Jochelson, MD 858-509-3670 Ext. 113 pjochelson@somaxon.com
California
Somaxon Phamaceuticals, San Diego, California, 92054, United States; Recruiting
Doranne Frano 858-509-3670 Ext. 103 dfrano@somaxon.com
Study chairs or principal investigators
Philip Jochelson, MD, Study Director, Somaxon Pharmaceuticals CMO
More Information
Study ID Numbers: SP-N0406
Last Updated: August 18, 2005
Record first received: August 17, 2005
ClinicalTrials.gov Identifier: NCT00132119
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-23
Last Updated: August 18, 2005
Record first received: August 17, 2005
ClinicalTrials.gov Identifier: NCT00132119
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-23
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