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Treatment of Patients With Anxiety Disorder (0777-022)

Primary Purpose

Generalized Anxiety Disorder

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
MK0777
Comparator: placebo (unspecified)
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 1, 2007
    Last Updated
    October 30, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00539578
    Brief Title
    Treatment of Patients With Anxiety Disorder (0777-022)
    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
    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 purpose of the study is to examine the safety and efficacy of MK0777 during treatment for 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
    270 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    MK0777
    Intervention Description
    Duration of Treatment: 4 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: placebo (unspecified)
    Intervention Description
    Duration of Treatment: 4 weeks

    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 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
    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

    Treatment of Patients With Anxiety Disorder (0777-022)

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