Twenty-Six Week Extension Trial of Org 50081 in Outpatients With Chronic Primary Insomnia (176003) - Full Text View

Purpose

This trial is a twenty-six week, open label extension trial to investigate safety and explore efficacy of org 50081in patients with insomnia who completed protocol 21106.

Condition	Intervention	Phase
Sleep Initiation and Maintenance Disorders Mental Disorders Dyssomnias Sleep Disorders Sleep Disorders, Intrinsic	Drug: Org 50081	Phase III

MedlinePlus related topics:

Mental Health Sleep Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	A Twenty-Six Weeks, Open-Label Extension Trial to Evaluate Safety and Efficacy of Org 50081 in Outpatients With Chronic Primary Insomnia Who Completed Clinical Trial Protocol 21106

Further study details as provided by Organon:

Primary Outcome Measures:

Long term safety with regards to (serious)Adverse Events, clinical and physical examination, ECG, Laboratory parameters. [ Time Frame: During 26 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Patient reports from electronic sleep diaries [ Time Frame: During 26 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	211
Study Start Date:	October 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental Org 50081 one tablet daily	Drug: Org 50081 4.5 mg tablet / once daily

Eligibility

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

Criteria

Inclusion Criteria:

Sign written informed consent
Completed clinical trial 21106

Exclusion Criteria:

Any (serious) adverse event, medical condition or required concomitant medication deemed relevant for exclusion in trial 21106 as judged by the investigator
Were significantly non compliant with protocol criteria and procedures of trial 21106, as judged by the investigator
Pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00750919

Contacts


Contact: SP Clinical Trial Registry Call Center	1-888-772-8734

Sponsors and Collaborators

Organon

More Information

Responsible Party:	NV Organon, part of Schering-Plough Corporation ( Study Director )
Study ID Numbers:	176003
First Received:	September 10, 2008
Last Updated:	September 10, 2008
ClinicalTrials.gov Identifier:	NCT00750919
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Sleep Initiation and Maintenance Disorders

Signs and Symptoms

Mental Disorders

Neurologic Manifestations

Dyssomnias

Sleep Disorders

Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Pathologic Processes

Disease

Nervous System Diseases

ClinicalTrials.gov processed this record on October 06, 2008

Sponsored by:	Organon
Information provided by:	Organon
ClinicalTrials.gov Identifier:	NCT00750919