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Sleep Laboratory Study of MK0928 in Adult Patients With Primary Insomnia (0928-041)(TERMINATED)

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ClinicalTrials.gov Identifier: NCT00266357
Recruitment Status : Terminated
First Posted : December 16, 2005
Last Update Posted : January 14, 2015
Sponsor:
Information provided by:
H. Lundbeck A/S

Brief Summary:
A study to evaluate the efficacy, safety and tolerability of MK-0928 in Primary Insomnia.

Condition or disease Intervention/treatment Phase
Primary Insomnia Drug: MK0928, gaboxadol / Duration of Treatment: 6 days for treatment periods (2 days/dose) Drug: Placebo / Duration of Treatment: 2 days for screening period Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: MK0928 Phase II Sleep Laboratory Study - Primary Insomnia
Study Start Date : November 2005
Primary Completion Date : March 2007



Primary Outcome Measures :
  1. Mean of total sleep time over 2 nights.

Secondary Outcome Measures :
  1. Mean of other PSG sleep parameters over 2 nights, mean of subjective sleep parameters, and exploratory residual effect.


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a diagnosis of primary insomnia

Exclusion Criteria:

  • Patients with an active psychiatric disorder other than primary 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): NCT00266357


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

ClinicalTrials.gov Identifier: NCT00266357     History of Changes
Other Study ID Numbers: 0928-041
2005_107
First Posted: December 16, 2005    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