A Study of MK0777 Gel Extrusion Module (GEM) in the Treatment of Outpatients With Generalized Anxiety Disorder

This study has been completed.

First Received: June 22, 2008 Last Updated: June 23, 2008 History of Changes

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00703833

Purpose

The study will look at the effectiveness of MK0777 in patients with Generalized Anxiety Disorder.

Condition	Intervention	Phase
Generalized Anxiety Disorder	Drug: MK0777 Drug: Placebo (unspecified)	Phase II

MedlinePlus related topics: Anxiety

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Double-Blind, Multicenter, Placebo-Controlled Study of MK0777 Gel Extrusion Module (GEM) 1.5 mg b.i.d. in the Treatment of Outpatients With Generalized Anxiety Disorder

Further study details as provided by Merck:

Primary Outcome Measures:

Measure the reduction of anxiety [ Time Frame: after 4 weeks and at end of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety and efficacy [ Time Frame: throughout study and at end of study ] [ Designated as safety issue: Yes ]

Enrollment:	51
Primary Completion Date:	October 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Drug	Drug: MK0777 Days 1-3 3mg MK0777, Days 4-7 6 mg MK0777, Days 8-28 3, 6 or 9 mg MK0777
2: Placebo Comparator Placebo	Drug: Placebo (unspecified) matching placebo

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00703833

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2007_630, MK0777-019
Study First Received:	June 22, 2008
Last Updated:	June 23, 2008
ClinicalTrials.gov Identifier:	NCT00703833 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Anxiety Disorders
Mental Disorders

Additional relevant MeSH terms:

Pathologic Processes
Disease
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 07, 2009