Case study in Clinical trials
Evaluation of the safety and preliminary efficacy in patients with constipation due to the use of opioid-based medications for the management of chronic non cancer pain. A randomized placebo-controlled study See all the case studiesGet in touchKey information
Study endpoints
– Frequency of spontaneous bowel movement
– Bowel function
– Gastro intestinal symptoms
Population
126 constipated patients using opioids
Tested product
Live Biotherapeutic Product (LBP)
Investigations
3 centres in France (hospitals)
Key challenge
– Stable dosage of opioids during the study
– Stopping laxatives not accepted