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
Phase 3
Completed
- Conditions
- sleeplessnessinsomniaslaapstoornissen
- Registration Number
- NL-OMON33547
- Lead Sponsor
- Schering-Plough
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 16
Inclusion Criteria
sign written informed consent
completed trial 21106 (i.e. completed 26 weeks of treatment and finished the 7-day discontinuation period)
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
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To investigate safety and tolerability of long-term treatment with Org 50081 in<br /><br>adult patients with chronic primary insomnia.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To collect exploratory efficacy data of long-term treatment with Org 50081 in<br /><br>adult patients with chronic primary insomnia.</p><br>