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

October 30, 2015 updated by: Merck Sharp & Dohme LLC

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 2
Placebo
Drug: Placebo (unspecified)
matching placebo
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measure the reduction of anxiety
Time Frame: after 4 weeks and at end of study
after 4 weeks and at end of study

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety and efficacy
Time Frame: throughout study and at end of study
throughout study and at end of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Primary Completion (ACTUAL)

February 1, 2003

Study Completion (ACTUAL)

February 1, 2003

Study Registration Dates

First Submitted

June 22, 2008

First Submitted That Met QC Criteria

June 23, 2008

First Posted (ESTIMATE)

June 24, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

November 1, 2015

Last Update Submitted That Met QC Criteria

October 30, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0777-019
  • MK0777-019
  • 2007_630

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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