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A Prospective Active-Reference Study of Gaboxadol in Primary Insomnia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00209937
First Posted: September 21, 2005
Last Update Posted: March 30, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
H. Lundbeck A/S
  Purpose
To evaluate the efficacy safety and tolerability of gaboxadol in primary insomnia

Condition Intervention Phase
Primary Insomnia Drug: Gaboxadol Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Prospective Randomised Double-Blind Parallel-Group Placebo-Controlled Active-Reference Study of Gaboxadol in Primary Insomnia

Further study details as provided by H. Lundbeck A/S:

Primary Outcome Measures:
  • Efficacy
  • Safety
  • Tolerability

Estimated Enrollment: 675
Study Start Date: January 2003
Study Completion Date: June 2004
Detailed Description:
To compare the hypnotic efficacy and safety of different dose levels of gaboxadol with placebo in non-elderly patients with primary insomnia over two weeks of treatment
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of Primary insomnia
  Contacts and Locations
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): NCT00209937


Sponsors and Collaborators
H. Lundbeck A/S
Investigators
Study Director: Please contact: Annelies van der Hammen Legters H. Lundbeck A/S
  More Information

ClinicalTrials.gov Identifier: NCT00209937     History of Changes
Other Study ID Numbers: 99775
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: March 30, 2007
Last Verified: March 2007

Keywords provided by H. Lundbeck A/S:
Primary insomnia

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


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