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

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

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

Locations

United States, Florida
Investigational Site 150	Recruiting
Maitland, Florida, United States, 32751
United States, Georgia
Investigational Site 151	Recruiting
Atlanta, Georgia, United States, 30328
United States, Kentucky
Investigational Site 148	Recruiting
Crestview Hills, Kentucky, United States, 41017
United States, Massachusetts
Investigational Site 138	Recruiting
Springfield, Massachusetts, United States, 01107
United States, Pennsylvania
Investigational Site 149	Recruiting
West Chester, Pennsylvania, United States, 19382
United States, Vermont
Investigational Site 139	Recruiting
Essex Junction, Vermont, United States, 05452
United States, Virginia
Investigational Site 152	Recruiting
Richmond, Virginia, United States, 23294
United States, Washington
Investigational Site 153	Recruiting
Seattle, Washington, United States, 98104
Investigational Site 154	Recruiting
Wenatchee, Washington, United States, 98801
Canada
Investigational Site 121	Recruiting
Toronto, Canada, M9W 4L6
Investigational Site 143	Recruiting
Sarnia, Canada, N7T 4X3
Sweden
Investigational Site 135	Recruiting
Halmstad, Sweden, SE-302 27
Investigational Site 123	Recruiting
Göteborg, Sweden, SE-413 45
Investigational Site 134	Recruiting
Göteborg, Sweden, SE-412 55
Investigational Site 122	Recruiting
Örebro, Sweden, SE-701 85

Sponsors and Collaborators

Organon

More Information

Responsible Party:	NV Organon, part of Schering-Plough Corporation ( Study Director )
Study ID Numbers:	176003, P05721
Study First Received:	September 10, 2008
Last Updated:	January 9, 2009
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 January 16, 2009