Movicol® in the treatment of constipation in Irritable Bowel Syndrome

• Research type

  Research Study

• Full title

  A Phase IIIb/IV, multi-centre, double-blind, randomised, placebo-controlled parallel group study to compare the efficacy and safety of Movicol® with placebo in patients with constipation associated with Irritable Bowel Syndrome (IBS).

• IRAS ID

  5164

• Contact name

  Roger Chapman

• Sponsor organisation

  Norgine Pharmaceuticals Ltd.

• Eudract number

  2008-000550-12

• ISRCTN Number

  n/a

• Research summary

  Irritable Bowel Syndrome withconstipation (IBSc) is a form of IBS. Current treatments for constipation canexacerbate pain or bloating or be used only for short periods of time. The needfor a gentler and more effective relief of constipation in this group ofpatients is required. This study is designed to test the safety andeffectiveness of Movicol© in the treatment of constipation associated with IBSwhen compared to placebo (an identical medication but containing no activedrug). The study will take place at hospital sites in the UK and Europe.Participants will attend the hospital site on four occasions over 28 days witha phonecall from the site on day 56 for follow up. Approximately 210participants will be randomised to gain 180 evaluable participants. Atscreening, participants will be issued with a diary card to record daily eventsincluding bowel movements, adverse events, concomitant medications and use ofrescue medication over the next 14 days (run-in period). A supply of rescuemedication will be provided to the participant at this visit. At visit 2(baseline) if participants remain eligible, they will be randomly assigned toeither Movicol© or placebo treatment. Treatment will continue for up to 28 dayswith visits to the hospital at days 14 and 28 of treatment. Completion of diarycards and available use of rescue medication continues throughout the durationof the study. All participants will be trained on completion of diary cards anduse of both the study and rescue medications to aid study compliance.Participants will also be asked to complete a Quality of Life questionnaire(the validated SF36 questionnaire) both prior to and following treatment.Participants will be followed up by phonecall at day 56 following treatment toassess any unresolved or new adverse events that may have occurred.

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  08/H0405/58

• Date of REC Opinion

  7 Nov 2008

• REC opinion

  Further Information Favourable Opinion