Conditions: Opioid-induced Constipation
Keywords: Opioid-induced Constipation
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 547
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of naldemedine in the treatment of opioid-induced constipation (OIC) in adults with non-malignant chronic pain who are not using laxatives.

Detailed description:

Arms:
arm 1: Participants received 0.2 mg naldemedine orally once daily for 12 weeks. arm 2: Participants received matching placebo orally once daily for 12 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: