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A Study of MK0777 Gel Extrusion Module (GEM) in the Treatment of Outpatients With Generalized Anxiety Disorder (0777-019)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00703833
First Posted: June 24, 2008
Last Update Posted: November 2, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]

Secondary Outcome Measures:
  • Safety and efficacy [ Time Frame: throughout study and at end of study ]

Enrollment: 51
Study Start Date: September 2002
Study Completion Date: February 2003
Primary Completion Date: February 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
Placebo Comparator: 2
Placebo
Drug: Placebo (unspecified)
matching placebo

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00703833


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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00703833     History of Changes
Other Study ID Numbers: 0777-019
MK0777-019
2007_630
First Submitted: June 22, 2008
First Posted: June 24, 2008
Last Update Posted: November 2, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Disease
Anxiety Disorders
Pathologic Processes
Mental Disorders