Treatment of Patients With Anxiety Disorder (0777-022)

Generalized Anxiety Disorder Clinical Trial

Official title:

A Double-Blind, Mulitcenter, Placebo-Controlled, Flexible-Dose Replicate Study of MK0777 Gel Extrusion Module (GEM) 3 mg B.I.D. to 8 mg B.I.D. in the Treatment of Outpatients With Generalized Anxiety Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00539578
• Other study ID #: 0777-022
• Secondary ID: MK0777-0222007_6
• Status: Completed
• Phase: Phase 2
• First received: October 1, 2007
• 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 purpose of the study is to examine the safety and efficacy of MK0777 during treatment for Generalized Anxiety Disorder.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• 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 and Female patients ages 18 to 70

Exclusion Criteria:

• Women who are breastfeeding or pregnant

• Positive result at prestudy on urine drug screen for illicit drugs

• History of alcohol or drug abuse

Study Design

Allocation: Randomized, Endpoint Classification: Safety/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
Duration of Treatment: 4 weeks
• Comparator: placebo (unspecified)
Duration of Treatment: 4 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.