Safety Follow-up to Overactive Bladder Study in Postmenopausal Women

• Research type

  Research Study

• Full title

  Safety Follow-Up Plan for MK-0634 Protocol 007 (MK-0634 Protocol 007 was A Multicentre, Double-Blind, Randomised, Placebo-Controlled, Parallel-Group, Dose-Ranging Study of L-000796568 in Postmenopausal Women With Overactive Bladder)

• IRAS ID

  8559

• Contact name

  Paul Robinson

• Sponsor organisation

  Merck & Co., Inc

• Eudract number

  2005-004499-19

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This is a safety follow up study for patients who previously took part in a trial looking at overactive bladder in post-menopausal women. The aim of this previous study was to find out if a new experimental drug known as L-000796568 (MK0634) could reduce the amount of daily urination, and if L-000796568 (MK0634) was well tolerated. Those patients in the previous study, who received the highest dose of MK0634 or received a placebo (dummy pill) will be invited to undergo safety follow up and therefore undergo certain eye examinations. It is expected that the safety follow up procedures will be completed within 2 months of visit 1 and that 12 patients in the UK will participate in this safety follow up study (23 patients in the UK originally took part in the study).

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  08/H0405/62

• Date of REC Opinion

  22 Jan 2009

• REC opinion

  Further Information Favourable Opinion