A Phase 2, Double-Blind, Multiple-Dose Escalation Study to Evaluate NKTR-118 (Oral PEG-Naloxol) in Patients With Opioid-Induced Constipation (OIC)

A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Multiple-Dose, Dose Escalation Study to Evaluate the Efficacy, Safety and Tolerability of NKTR-118 in Patients With Opioid-Induced Constipation (OIC)

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.

Main Inclusion Criteria:

• 18 years of age or older, male or female
• Receiving a stable opioid regimen
• Documented opioid-induced constipation
• Willingness to stop all laxatives and other bowel regimens. The use of constipation rescue medication will be allowed during the study.

Main Exclusion Criteria:

• Life expectancy less than 6 months
• Active substance abuse
• Fecal incontinence, irritable bowel syndrome, inflammatory bowel disease, or other active medical disorders associated with diarrhea or intermittent loose stools or constipation
• Pregnant or breast-feeding
• Any receipt of an investigational medication within 30 days of screening
• History or presence of specific cardiac, neurologic, endocrine and/or psychiatric conditions