safety and efficacy study of Lubiprostone in OBD

• Research type

  Research Study

• Full title

  A Multicenter, Randomized, Placebo-controlled, Double-blinded Study of the Efficacy and Safety of Lubiprostone in Patients with Opioid-induced Bowel Dysfunction

• IRAS ID

  65522

• Contact name

  tom cahill

• Sponsor organisation

  Sucampo Pharma Americas, Inc.

• Eudract number

  2010-022991-29

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Opioids, such as morphine, are widely used today in the management of acute and chronic pain, and are known to inhibit gastrointestinal motility by binding to a variety of different receptors in the central and peripheral nervous system. One of the most common side effects reported in opioid pain management is opioid induced bowel dysfunction (OBD). Though studies have shown that tolerance develops to the analgesic effects of opioids such as sedation, nausea and/or vomiting, rarely does such tolerance develop for the effects of constipation. OBD is characterized by dry, hard stool, straining during evacuation, abdominal bloating or distension, nausea, vomiting, and sometimes gastric retention. Studies have shown that long-term opioid use for chronic pain management results in greater bowel dysfunction. Adult subjects >18 years will be screened and if eligible randomized (1:1 ratio) to receive placebo or lubiprostone. The subjects will take 48 mcg/day (one 24 mcg in the morning and one 24 mcg dose in the evening) of oral lubiprostone or placebo for a 12 week treatment period. Subjects will be allowed to take a laxative (bisocodyl) as rescue medication during the trial but only if have not had a bowel movement for 3 or more consecutive days. They will complete a daily electronic diary recording medication and bowel movements. The subjects will visit the trial centre for different assessments for efficacy, safety and tolerability at screening, baseline, weeks 4, 8 and 12. They will also be assessed by telephone at weeks 1, 6 and 10 with a follow up visit at week 14.

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  11/H0405/5

• Date of REC Opinion

  1 Feb 2011

• REC opinion

  Further Information Favourable Opinion