Phase 2 N=207 Randomized Double-blind Treatment

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

Opioid Induced Constipation (OIC)

Bottom Line

View on ClinicalTrials.gov: NCT00600119 ↗

Enrolled (actual)

207

Serious AEs

2.6%

Results posted

Jun 2015

Primary outcome: Primary: Change From Baseline in Spontaneous Bowel Movements (SBMs) Per Week During Week 1 — 1.8; 2.6; 1.9; 3.6 Number of SBMs/week — p=0.7781

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: placebo (Drug); NKTR-118 (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: AstraZeneca
Primary completion: Mar 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Spontaneous Bowel Movements (SBMs) Per Week During Week 1	1.8; 2.6; 1.9; 3.6; 1.9; 4.4	0.7781
SECONDARY Change From Baseline in SBMs/Week Across the 28-day Double-blind Period	1.7; 2.3; 1.7; 3.2; 1.2; 4.6	0.5118
SECONDARY Change From Baseline in Patient Assessment of Constipation-Quality of Life (PAC-QOL) Questionnaire	1.4; 1.2; 1.7; 1.2; 1.7; 1.3	0.5522
SECONDARY Change From Baseline in Patient Assessment of Constipation-Symptoms (PAC-SYM) Questionnaire	1.2; 1.1; 1.4; 1.1; 1.2; 1.3	0.5008

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00600119). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.