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

Generalized Anxiety Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00703833
• Other study ID #: 0777-019
• Secondary ID: MK0777-0192007_6
• Status: Completed
• Phase: Phase 2
• First received: June 22, 2008
• Last updated: October 30, 2015
• Start date: September 2002
• Est. completion date: February 2003

Study information

• Verified date: October 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: February 2003
• Est. primary completion date: February 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety Disorder

Intervention

Drug:
• MK0777
Days 1-3 3mg MK0777, Days 4-7 6 mg MK0777, Days 8-28 3, 6 or 9 mg MK0777
• Placebo (unspecified)
matching placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure the reduction of anxiety		after 4 weeks and at end of study	No
Secondary	Safety and efficacy		throughout study and at end of study	Yes