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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Disease
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014