Oct 13: Compose III (NCT01965652) a phase III trial will study the long-term safety of naldemedine daily vs. placebo for the treatment of opioid-induced constipation in subjects with non-malignant chronic pain receiving opioid therapy. The primary outcome is number of major adverse cardiac events over a 1 year period. The study aims to enrol 1500 patients and is due to complete in May 16 . 30/03/2015 17:07:04
Aug 13: A phase III trial (NCT01965158; COMPOSE 1) to assess the safety and efficacy of naldemedine (0.2mg once daily) for the treatment of opioid-induced constipation in patients with non-malignant chronic pain is underway. Patients will receive naldemedine or placebo once daily for 12 weeks. The primary efficacy outcome is proportion of responders who have a spontaneous bowel movement. The study is due to complete in July 15 . 30/03/2015 17:00:53
Nov 13: NCT01993940 is a randomized, double-blind, placebo-controlled PIII study of naldemedine (0.2 mg once daily) in the treatment of opioid-induced constipation in 540 subjects with non-malignant chronic pain receiving opioid therapy. The primary efficacy endpoint is the proportion of responders who have a spontaneous bowel movement. The study starts Nov 13 and is due to complete Feb 16 . 26/11/2013 17:47:07
Opioid-induced constipation is a side effect that affects nearly all patients taking opioid treatment and will persist unless treated. The prevalence of opioid-induced constipation is not known. However, in England in 2010 there were over 17 million prescriptions for opioid items. In 2010-11 there were 57,506 hospital admissions due to constipation in England, and in 2011, there were 57 deaths registered in England and Wales due to constipation.