NCT00600119

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 207 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Opioid Induced Constipation (OIC)

Interventions

Type	Name	Description
DRUG	placebo	placebo, oral, once daily (QD)
DRUG	NKTR-118	5 mg, 25 mg, 50 mg or 100 mg, oral,once daily (QD)

Timeline

• Start date: 2007-12-01
• Primary completion: 2009-03-01
• Completion: 2009-04-01
• First posted: 2008-01-24
• Last updated: 2015-06-12
• Results posted: 2015-06-12

Locations

33 sites across 1 country: United States