Twenty-six Week Extension Trial of Org 50081 in Outpatients With Chronic Primary Insomnia (176003)(P05721AM1)(COMPLETED)

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: September 10, 2008
Last updated: October 24, 2013
Last verified: October 2013

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
Sleep Disorders
Sleep Disorders, Intrinsic
Drug: Org 50081
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

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 ]

Enrollment: 184
Study Start Date: October 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Org 50081 one tablet daily
Drug: Org 50081
4.5 mg tablet / once daily


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

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
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00750919     History of Changes
Other Study ID Numbers: P05721, 176003
Study First Received: September 10, 2008
Last Updated: October 24, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Sleep Disorders
Sleep Disorders, Intrinsic
Mental Disorders
Psychotic Disorders
Sleep Initiation and Maintenance Disorders
Schizophrenia and Disorders with Psychotic Features
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms processed this record on April 23, 2014