Neptune - Placebo-controlled acute study 905-CL-055

• Research type

  Research Study

• Full title

  A randomized, double-blind, parallel group, placebo controlled, multicentre study of fixed dose combinations of solifenacin succinate (6 mg and 9 mg) with tamsulosin hydrochloride OCAS 0.4 mg and tamsulosin hydrochloride OCAS 0.4 mg monotherapy, in male subjects with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) with a substantial storage component.

• IRAS ID

  23127

• Sponsor organisation

  Chiltern International Ltd

• Eudract number

  2008-001211-37

• Research summary

  Men suffering from lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) may benefit from drug treatment. Some drugs are already available, but these may not alleviate both storage and voiding symptoms. The purpose of this study is to assess various combinations of two drugs (tamsulosin and solifenacin) to see if the combination is better than the standard treatment (tamsulosin) alone. If the patient decides to enter the study, he will be allocated by chance (randomized) to one of four different treatment groups, including one monotherapy group (one tamsulosin), two combination groups (standard tamsulosin plus one of the two solifenacin doses) or placebo (dummy tablets). Patients in each group will receive a different treatment and the groups will be compared at the end of the study.The study will comprise a single-blind, 2-week placebo run-in period followed by a randomized, double-blind, placebo controlled, 12-week treatment period. Subjects will visit the clinic at screening (Visit 1), at the end of the placebo run-in period (Visit 2), and after 6, 10 and 14 weeks of double-blind treatment (Visits 3, 4, and 5).

• REC name

  South West - Central Bristol Research Ethics Committee

• REC reference

  09/H0106/62

• Date of REC Opinion

  16 Sep 2009

• REC opinion

  Further Information Favourable Opinion