Randomized phase III and extension studies: efficacy and impacts on quality of life of naldemedine in subjects with opioid-induced constipation and cancer

Annals of Oncology : Official Journal of the European Society for Medical Oncology
Nobuyuki KatakamiNarikazu Boku

Abstract

The efficacy and safety of naldemedine (a peripherally acting µ-opioid receptor antagonist) for opioid-induced constipation (OIC) in subjects with cancer was demonstrated in the primary report of a phase III, double-blind study (COMPOSE-4) and its open-label extension (COMPOSE-5). The primary end point, the proportion of spontaneous bowel movement (SBM) responders, was met. Here, we report results from secondary end points, including quality of life (QOL) assessments from these studies. In COMPOSE-4, eligible adults with OIC and cancer were randomly assigned 1:1 to receive once-daily oral naldemedine 0.2 mg (n = 97) or placebo (n = 96) for 2 weeks, and those who continued on to COMPOSE-5 received naldemedine for 12 weeks (n = 131). Secondary assessments in COMPOSE-4 included the proportion of complete SBM (CSBM) responders, SBM or CSBM responders by week, and subjects with ≥1 SBM or CSBM within 24 h postinitial dose. Changes from baseline in the frequency of SBMs or CSBMs per week were assessed at weeks 1 and 2. Time to the first SBM or CSBM postinitial dose was also evaluated. In both studies, QOL impact was evaluated by Patient Assessment of Constipation-Symptoms (PAC-SYM) and PAC-QOL questionnaires. Naldemedine improved bowe...Continue Reading

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Citations

Oct 4, 2018·Pharmaceutical Research·Ryuji KubotaToshihiro Wajima
Jun 4, 2020·Pain Medicine : the Official Journal of the American Academy of Pain Medicine·Rong OuyangJiean Huang
Jun 18, 2020·Journal of Pain Research·Flaminia ColuzziJoseph Pergolizzi
Aug 3, 2021·Journal of Pain Research·Flaminia ColuzziFabio Lugoboni

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