Evaluation of prucalopride in male subjects with chronic constipation

• Research type

  Research Study

• Full title

  A 12 week randomised, double-blind, placebo-controlled trial to evaluate the efficacy, quality of life, safety and tolerability of prucalopride in male subjects with chronic constipation

• IRAS ID

  48999

• Contact name

  Mark Blagden

• Sponsor organisation

  Movetis NV

• Eudract number

  2009-015719-42

• ISRCTN Number

  n/a

• Research summary

  Prucalopride (Resolor©) is a new drug for the symptomatic treatment of chronic constipation in women in whom laxatives fail to provide adequate relief (approved by European commission October 2009). Prucalopride has been shown to effectively increase the number of stools and increase quality of life in patients with chronic constipation. Prucalopride has been given to approximately 2700 patients with chronic constipation in clinical studies. The number of males in the studies was limited, this trial will evaluate efficacy of prucalopride versus placebo over 12 weeks of treatment in male subjects with chronic constipation. In addition, the safety, tolerability, effect on quality of life and effect on symptoms of chronic constipation will be evaluated.Subjects will be screened and enter a 2-week run-in period (or 3-week run-in period if the subject is using agents that influence bowel habit) during which the presence of constipation will be confirmed After the run-in subjects will be randomly assigned to placebo or prucalopride in an equal ratio (1:1) if the subject fulfils the constipation criteria for inclusion.Adult subjects (=18 to <65 years of age) will take 2 mg prucalopride or placebo once daily during the entire 12-week treatment period. Elderly subjects (i.e. subjects =65 years of age) will start at a dose of 1 mg prucalopride or placebo once daily before breakfast. In case of insufficient response, the daily dose has to be increased to 2 mg (or matching placebo). Subjects will be allowed to take a laxative (bisacodyl) as rescue medication during the trial, but only if they have not had a bowel movement for 3 or more consecutive days. Subjects will visit the trial centre for different assessments on for efficacy, safety and tolerability at screening (start of run-in), on baseline and after 2, 4, 8 and 12 weeks of treatment.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  10/H1208/46

• Date of REC Opinion

  5 Aug 2010

• REC opinion

  Further Information Favourable Opinion