Phase 3
N=844
Assessment of Long-term Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation
Opioid-Induced Constipation (OIC)
Bottom Line
View on ClinicalTrials.gov: NCT01336205 ↗Enrolled (actual)
844
Serious AEs
10.1%
Results posted
Oct 2014
Primary outcome: Primary: Incidence of Patients Experiencing at Least One Adverse Event (AE) — 437; 195 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- NKTR-118 (Drug); Usual care (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Patients Experiencing at Least One Adverse Event (AE) |
437; 195 | — |
| PRIMARY Incidence of Patients Experiencing AEs That Resulted in Discontinuation of Investigational Product (IP) |
56; NA | — |
| PRIMARY Incidence of Patients Experiencing Severe Adverse Events (SAEs) |
51; 30 | — |
Summary
The purpose of this study is to evaluate the long-term safety and tolerability of NKTR-118 treatment of opioid-induced constipation (OIC) in patients with non-cancer-related pain.
Eligibility Criteria
Inclusion Criteria
- Provision of written informed consent prior to any study-specific procedures.
- NEW PATIENTS ONLY: Self-reported active symptoms of OIC at screening ( 1 reported symptom of hard/lumpy stools, straining, or sensation of incomplete evacuation/anorectal obstruction in at least 25% of the BMs over the previous 4 weeks); and Documented confirmed OIC (<3 SBMs/week on average over the 2-week OIC confirmation period.
- PATIENTS ENROLLING FROM OTHER NKTR-118 STUDIES: Receiving a stable maintenance opioid regimen consisting of a total daily dose of 30 mg to 1000 mg or oral morphine, or equianalgesic amount(s) of 1 or more opioid therapies.
- FOR PATIENTS RANDOMIZED TO RECEIVE NKTR-118: Willingness to stop all laxatives and other bowel regimens including prune juice and herbal products throughout the 52-week treatment period, and to use only bisacodyl as rescue medication if BM has not occurred within at least 72 hours of the last recorded BM.
Exclusion Criteria
- Patients receiving Opioid regimen for treatment of pain related to cancer.
- History of cancer within 5 years from first study visit with the exception of basal cell cancer and squamous cell skin cancer.
- Medical conditions and treatments associated with diarrhea, intermittent loose stools, or constipation.
- Other issues related to the gastrointestinal tract that could impose a risk to the patient.
- Pregnancy or lactation.
Data sourced from ClinicalTrials.gov (NCT01336205). 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.