Trial Information

Summary: A dose escalation study of NKTR-118 in patients with opioid-induced constipation (OIC).

A Phase 2 study designed to evaluate the safety and efficacy of NKTR-118 (PEG-naloxol) in patients with opioid-induced constipation. The objectives of this study are to evaluate the safety, effectiveness and pharmacokinetics of NKTR-118 at 4 different doses. The study is a multi-center, placebo-controlled, double-blind, randomized, dose-escalation trial. The study plans to enroll 224 patients at about 50 sites in the US, Canada and the EU.

Key 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.

Key Exclusion Criteria:

• Life expectancy <6 months
• Active substance abuse
• Fecal incontinence, irritable bowel syndrome, inflammatory bowel disease, or other active medical disorder 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

If you would like to learn more about participating in this study, please send an e-mail message using the form below.