Prucalopride in chronic pain patients with opioid induced constipation

• Research type

  Research Study

• Full title

  A 12-week, randomised, double-blind, placebo-controlled trial to evaluate the efficacy and safety of prucalopride in subjects with chronic non-cancer pain suffering from opioid induced constipation

• IRAS ID

  46326

• Contact name

  William Notcutt

• Sponsor organisation

  Shrie - Movetis NV

• Eudract number

  2009-015652-20

• Clinicaltrials.gov Identifier

  01117051

• Research summary

  Prucalopride (Resolor©) is a new drug for treatment of chronic constipation in women in whom laxatives fail to provide adequate relief. It has been demonstrated that prucalopride is effective in increasing stool frequency and improving associated symptoms and quality of life in patients with chronic constipation. In addition, prucalopride has been studied in patients with chronic non-cancer pain who suffer from constipation related to their opioid ( a type of painkiller) use. This clinical trial will be conducted to study the effectiveness and safety of prucalopride in a larger number of patients (510) with chronic non-cancer pain suffering from opioid induced constipation. The trial will also study the concentrations of prucalopride in blood after intake by mouth. Half of the patients will receive placebo (a tablet that looks exactly like a prucalopride tablet (but contains no active drug) and half of the patients will receive 2 mg prucalopride per day. Patients aged 65 years or older will start with placebo or 1 mg prucalopride per day. People who are 18 years of age or older, who have chronic non-cancer pain requiring stable daily maintenance treatment with opioids, and who suffer from constipation related to this opioid use are being invited to take part. If they consent to take part in the study they will attend a total of 6 study visits at a hospital research site over a period of approximately 15 weeks. This study is being sponsored by Movetis MV.

• REC name

  West of Scotland REC 1

• REC reference

  10/S0703/31

• Date of REC Opinion

  2 Jun 2010

• REC opinion

  Further Information Favourable Opinion