A Prospective Active-Reference Study of Gaboxadol in Primary Insomnia

This study has been completed.

First Received: September 13, 2005 Last Updated: March 29, 2007 History of Changes

Sponsored by:	H. Lundbeck A/S
Information provided by:	H. Lundbeck A/S
ClinicalTrials.gov Identifier:	NCT00209937

Purpose

To evaluate the efficacy safety and tolerability of gaboxadol in primary insomnia

Condition	Intervention	Phase
Primary Insomnia	Drug: Gaboxadol	Phase III

Drug Information available for: Gaboxadol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

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

Keywords provided by H. Lundbeck A/S:

Primary insomnia

Study placed in the following topic categories:

4,5,6,7-tetrahydroisoxazolo(5,4-c)pyridin-3-ol
Sleep Initiation and Maintenance Disorders
Neurotransmitter Agents
Mental Disorders
GABA Agonists
Dyssomnias

Sleep Disorders
Peripheral Nervous System Agents
Analgesics
Anticonvulsants
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders
4,5,6,7-tetrahydroisoxazolo(5,4-c)pyridin-3-ol
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Nervous System Diseases
Dyssomnias
Sleep Disorders
Pharmacologic Actions
Sleep Disorders, Intrinsic

Sensory System Agents
Mental Disorders
Therapeutic Uses
GABA Agonists
GABA Agents
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on May 07, 2009