Back to resultsA Study of MK0777 Gel Extrusion Module (GEM) in the Treatment of Outpatients With Generalized Anxiety Disorder (0777-019)
Primary Purpose
Generalized Anxiety Disorder
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
MK0777
Placebo (unspecified)
Sponsored by
About this trial
This is an interventional treatment trial for Generalized Anxiety Disorder
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Drug
Placebo
Outcomes
Primary Outcome Measures
Measure the reduction of anxiety
Secondary Outcome Measures
Safety and efficacy
Full Information
NCT ID
NCT00703833
First Posted
June 22, 2008
Last Updated
October 30, 2015
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00703833
Brief Title
A Study of MK0777 Gel Extrusion Module (GEM) in the Treatment of Outpatients With Generalized Anxiety Disorder (0777-019)
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
February 2003 (Actual)
Study Completion Date
February 2003 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief Summary
The study will look at the effectiveness of MK0777 in patients with Generalized Anxiety Disorder.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Drug
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
MK0777
Intervention Description
Days 1-3 3mg MK0777, Days 4-7 6 mg MK0777, Days 8-28 3, 6 or 9 mg MK0777
Intervention Type
Drug
Intervention Name(s)
Placebo (unspecified)
Intervention Description
matching placebo
Primary Outcome Measure Information:
Title
Measure the reduction of anxiety
Time Frame
after 4 weeks and at end of study
Secondary Outcome Measure Information:
Title
Safety and efficacy
Time Frame
throughout study and at end of study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Study of MK0777 Gel Extrusion Module (GEM) in the Treatment of Outpatients With Generalized Anxiety Disorder (0777-019)
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