A Phase 2, Double-Blind, Multiple-Dose Escalation Study to Evaluate NKTR-118 (Oral PEG-Naloxol) in Patients With Opioid-Induced Constipation (OIC)
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.
Timeline
- Start
- 2007-12
- Primary completion
- 2009-03
- Completion
- 2009-04
Outcome
Met primary endpoint
registry analysis (superiority or other test); Placebo 25 mg vs NKTR-118 25 mg; p = 0.0020; Wilcoxon (Mann-Whitney) NCT00600119 ↗
registry analysis (superiority or other test); Placebo 50 mg vs NKTR-118 50 mg; p = 0.0001; Wilcoxon (Mann-Whitney) NCT00600119 ↗
release “In the phase II double blind, randomized, placebo-controlled study of 208 patients with opioid-induced constipation, NKTR-118 achieved the primary endpoint” nektar.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Naloxegol | Unknown | 5 mg | Oral |
| Subject | Naloxegol | Unknown | 25 mg | Oral |
| Subject | Naloxegol | Unknown | 50 mg | Oral |
| Subject | Naloxegol | Unknown | 100 mg | Oral |