A Phase 2, Double-Blind, Multiple-Dose Escalation Study to Evaluate NKTR-118 (Oral PEG-Naloxol) in Patients With Opioid-Induced Constipation (OIC)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
207 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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