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A Prospective Active-Reference Study of Gaboxadol in Primary Insomnia

This study has been completed.
Sponsor:
Information provided by:
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT00209937
First received: September 13, 2005
Last updated: March 29, 2007
Last verified: March 2007
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of Primary insomnia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00209937

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

No publications provided

ClinicalTrials.gov Identifier: NCT00209937     History of Changes
Other Study ID Numbers: 99775
Study First Received: September 13, 2005
Last Updated: March 29, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders
4,5,6,7-tetrahydroisoxazolo(5,4-c)pyridin-3-ol
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
 Pharmacologic Actions
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 21, 2013