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

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00703833
First received: June 22, 2008
Last updated: November 2, 2009
Last verified: November 2009
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or Female
  • Current diagnosis of Generalized Anxiety Disorder
  • Age 18 - 70

Exclusion Criteria:

  • Women who are pregnant, or breast-feeding
  • Use of illicit drugs
  • History of drug or alcohol dependence
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00703833

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00703833     History of Changes
Other Study ID Numbers: 2007_630, MK0777-019
Study First Received: June 22, 2008
Last Updated: November 2, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 15, 2014