Movetis starts Phase III clinical trial with prucalopride in patients with opioid-induced constipation (OIC)

New trial marks first step in Movetis’ label expansion strategy for Resolor

21-May-2010 - Belgium

Movetis NV announced that it has started a Phase III clinical trial with prucalopride in patients with constipation induced by opioid based pain medications. Positive results from its OIC clinical trial programme should allow Movetis to support a regulatory application for expansion of the current label of Resolor® (prucalopride), so that physicians could have access to a new and innovative oral medication for the treatment of OIC.

As the OIC market is segmented into cancer and non cancer-related OIC, the prucalopride Phase III programme for this potential new indication consists of two trials. The Phase III clinical trial with prucalopride in non cancer-related OIC patients has now started as the screening of the first patients has begun. This twelve-week randomised, double-blind, placebo-controlled trial will involve over 500 patients from centres in ten European countries. The Phase III trial in cancer-related OIC patients is expected to be initiated within the year, which should enable Movetis to finalise the OIC clinical study reports late 2012 - early 2013.

Prior to the Phase III programme, prucalopride was tested for treatment of OIC in a Phase II placebo-controlled study including 190 patients. In this study, prucalopride demonstrated an effect on bowel frequency and symptoms related to OIC. The study did not provide an indication for interaction with the opioid analgesic effect. 67.2% of patients in the 2mg prucalopride group had three or more spontaneous bowel movements (SBM) after one week of treatment, versus 46.9% in the placebo-group. For the more stringent criterion of spontaneous complete bowel movements (SCBM), response rates after one week of treatment were 25.0% for patients in the 2mg prucalopride group compared to 3.1% in the placebo group. Similar results were obtained over 4 weeks of treatment. These Phase II study findings support that there is a role for the drug in treating OIC, which will now be studied in Phase III studies involving larger patient groups.

https://www.bionity.com/en/news/117858/movetis-starts-phase-iii-clinical-trial-with-prucalopride-in-patients-with-opioid-induced-constipation-oic.html