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Efficacy and Safety of MK0928 for Insomnia in Adults (0928-003)(COMPLETED)

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ClinicalTrials.gov Identifier: NCT00095069
Recruitment Status : Completed
First Posted : November 1, 2004
Last Update Posted : January 14, 2015
Sponsor:
Information provided by:
H. Lundbeck A/S

Brief Summary:
The purpose of this trial is to study the safety and effectiveness of MK0928 for adults with insomnia.

Condition or disease Intervention/treatment Phase
Insomnia Drug: MK0928, gaboxadol / Duration of Treatment - 1 year Drug: Comparator: placebo / Duration of Treatment -1 year Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Multicenter, Placebo-Controlled, Parallel-Groups Efficacy and Safety Extension Study of MK0928 in the Treatment of Adult Outpatients With Primary Insomnia
Study Start Date : October 2004
Actual Primary Completion Date : February 2007
Actual Study Completion Date : February 2007



Primary Outcome Measures :
  1. Patient-reported amount of sleep and time to fall sleep at night after three months

Secondary Outcome Measures :
  1. Patient-reported awakenings at night
  2. Sleep quality
  3. Functioning after 3 months


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of insomnia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00095069


Sponsors and Collaborators
H. Lundbeck A/S
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00095069     History of Changes
Other Study ID Numbers: 0928-003
MK0928-003
2004_086
First Posted: November 1, 2004    Key Record Dates
Last Update Posted: January 14, 2015
Last Verified: January 2015

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Gaboxadol
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action