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Fifty Two Week Extension Trial of Org 50081 in the Treatment of Insomnia (176004)(P05708)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00610675
First received: January 9, 2008
Last updated: January 14, 2010
Last verified: January 2010
History of Changes
  Purpose

This trial is a 52-week, open-label extension trial to investigate safety and to explore efficacy of Org 50081 in subjects who completed Protocol 176001 or 176002. Subjects who have completed Protocol 176001 or 176002 and are willing to continue treatment with Org 50081, can participate in Protocol 176004 after signing informed consent.


Condition Intervention Phase
Insomnia
 Drug: Org 50081
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Fifty-Two Weeks, Open Label Extension Trial to Evaluate Safety and Efficacy of Org 50081 in Outpatients With Chronic Primary Insomnia Who Completed Clinical Trial Protocol 176001 or 176002

Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • To investigate long term safety with regard to laboratory values and side effect profile of long-term treatment with Org 50081 in adult patients with chronic primary insomnia. [ Time Frame: 52 Weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To collect exploratory efficacy data of long-term treatment with Org 50081 in adult patients with chronic primary insomnia. [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 309
Study Start Date: December 2006
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Org 50081-1
One tablet daily
 Drug: Org 50081
One tablet 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 after the scope and nature of the investigation have been explained to them, before any trial-related evaluations;
  • completed Protocol 176001 or 176002;
  • Have safety and efficacy assessments conducted per protocol 176001 or 176002.

Exclusion Criteria:

  • clinically relevant ECG abnormalities as judged by the investigator;
  • clinically relevant abnormal laboratory values as judged by the investigator;
  • any adverse event deemed relevant for exclusion in Protocol 176004 as judged by the investigator or,
  • were significantly non compliant with protocol criteria and procedures of Protocol 176001 or 176002, as judged by the investigator.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00610675     History of Changes
Other Study ID Numbers: 176004, P05708
Study First Received: January 9, 2008
Last Updated: January 14, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Schering-Plough:
Fifty two weeks
Open label
extension

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
 Sleep Disorders
Nervous System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on May 21, 2013