26 week open label extension of protocol 21106

• Research type

  Research Study

• Full 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

• Sponsor organisation

  Schering Plough Limited

• Eudract number

  2007-005237-10

• ISRCTN Number

  n.a

• Clinicaltrials.gov Identifier

  n.a

• Research summary

  This is a continuing questionnaire based study of a drug ORG50081, open to subjects who have completed a previous clinical trial. At the end a fasting blood sample and urine sample will be taken for laboratory investigations, a physical examination will be performed; and ECG recorded.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  08/H0304/83

• Date of REC Opinion

  28 Jan 2009

• REC opinion

  Further Information Favourable Opinion