Conditions: Opioid-induced Constipation
Keywords: Opioid Therapy Non-Malignant Chronic Pain Opioid-Induced Constipation
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 244
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine efficacy and safety of naldemedine for the treatment of opioid-induced constipation in adults with non-malignant chronic pain receiving opioid therapy for ≥ 3 months.

Detailed description:

Arms:
arm 1: Participants received placebo orally once daily for 28 days. arm 2: Participants received 0.1 mg naldemedine orally once daily for 28 days. arm 3: Participants received 0.2 mg naldemedine orally once daily for 28 days. arm 4: Participants received 0.4 mg naldemedine orally once daily for 28 days.

Interventions: intervention 1: Placebo intervention 2: Naldemedine
Intervention descriptions: intervention 1: Matching placebo tablets administered orally once a day. intervention 2: Naldemedine tablets administered orally once a day.

Protocol document: