Conditions: Opioid Induced Constipation (OIC)
Keywords: NKTR, constipation, opioid, induced, bowel, dysfunction, Naloxol, Naloxone, Narcan, PEG naloxol, OIC, OBD, Nektar
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 207
Healthy volunteers: no

Brief summary:
Study (07-IN-NX003) is a Phase 2, multi-center, placebo-controlled, double-blind, randomized, dose-escalation trial. It is designed to investigate the safety, efficacy and tolerability of NKTR-118 (PEG-naloxol) in patients with opioid-induced constipation (OIC) and other clinical manifestations of opioid-induced bowel dysfunction (OBD). The objective of this study is to evaluate the safety, effectiveness and pharmacokinetics of NKTR-118 at 4 different doses.

Detailed description:

Arms:
arm 1: Placebo arm 2: NKTR-118

Interventions: intervention 1: placebo intervention 2: NKTR-118
Intervention descriptions: intervention 1: placebo, oral, once daily (QD) intervention 2: 5 mg, 25 mg, 50 mg or 100 mg, oral,once daily (QD)

Protocol document: