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

NCT00600119 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 207

Last updated 2015-06-12

Study results available
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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

DRUG

placebo

placebo, oral, once daily (QD)

DRUG

NKTR-118

5 mg, 25 mg, 50 mg or 100 mg, oral,once daily (QD)

Sponsors & Collaborators

Principal Investigators

  • Mark Sostek · AstraZeneca Pharmaceuticals, Wilm DE

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2009-03-31
Completion
2009-04-30

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00600119 on ClinicalTrials.gov