Conditions: Opioid-induced Constipation
Keywords: Opioid Induced Constipation
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1246
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the long-term safety of naldemedine for the treatment of constipation due to opioid therapy.

Detailed description:

Arms:
arm 1: Participants received 0.2 mg naldemedine tablets orally once daily for 52 weeks. arm 2: Participants received matching placebo tablets orally once daily for 52 weeks.

Interventions: intervention 1: Naldemedine intervention 2: Placebo
Intervention descriptions: intervention 1: Naldemedine 0.2 mg tablet taken orally once a day intervention 2: Placebo tablet taken orally once a day

Protocol document: