search
Back to results

GEM 1.5 mg b.i.d. to 4.5 mg b.i.d. Versus Lorazepam in GAD (0777-026)

Primary Purpose

Anxiety Disorder

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
MK0777
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorder

Eligibility Criteria

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

Inclusion Criteria:

  • Have been diagnosed with Generalized Anxiety Disorder
  • Women of childbearing potential must use a double-barrier methods of contraception and must have a negative blood pregnancy test at the beginning of the study

Exclusion Criteria:

  • History of drug or alcohol abuse
  • Have previously participated in another study using MK0777

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 17, 2007
    Last Updated
    October 30, 2015
    Sponsor
    Merck Sharp & Dohme LLC
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00546624
    Brief Title
    GEM 1.5 mg b.i.d. to 4.5 mg b.i.d. Versus Lorazepam in GAD (0777-026)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    November 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
    This study will determine the effectiveness of MK0777 GEM versus Lorazepam in the treatment of patients with generalized anxiety disorder. This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anxiety Disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    38 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    MK0777

    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: Have been diagnosed with Generalized Anxiety Disorder Women of childbearing potential must use a double-barrier methods of contraception and must have a negative blood pregnancy test at the beginning of the study Exclusion Criteria: History of drug or alcohol abuse Have previously participated in another study using MK0777
    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

    GEM 1.5 mg b.i.d. to 4.5 mg b.i.d. Versus Lorazepam in GAD (0777-026)

    We'll reach out to this number within 24 hrs