An Investigational Study of MK0928 in Adult Outpatients With Insomnia (0928-014)(COMPLETED)

January 13, 2015 updated by: H. Lundbeck A/S

A Double-Blind, Randomized, Multicenter, Placebo-Controlled, Parallel-Group Efficacy Study of MK0928 15 mg and 10 mg in the Treatment of Adult Outpatients With Primary Insomnia

The purpose of this study is to evaluate the safety and effectiveness of MK0928 for insomnia (a sleep disorder).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

900

Phase

  • Phase 3

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 64 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult outpatients who are between the ages of 18 and 64

Exclusion Criteria:

  • Adults who do not have a diagnosis of insomnia (a sleep disorder)

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patient-reported amount of sleep and time to fall asleep at night after 3 months
Time Frame: After 3 months
After 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient-reported awakenings at night
Time Frame: After 3 months
After 3 months
Sleep quality
Time Frame: After 3 months
After 3 months
Functioning after 3 months
Time Frame: After 3 months
After 3 months

Collaborators and Investigators

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

Sponsor

H. Lundbeck A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2005

Study Completion (ACTUAL)

October 1, 2006

Study Registration Dates

First Submitted

February 15, 2005

First Submitted That Met QC Criteria

February 15, 2005

First Posted (ESTIMATE)

February 16, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

January 14, 2015

Last Update Submitted That Met QC Criteria

January 13, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0928-014
  • MK0928-014
  • 2005_002

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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