Assessment of Long-term Safety in Patients With Non-cancer-related Pain and Opioid-induced Consti… (NCT01336205) | Clinical Trial Compass
CompletedPhase 3
Assessment of Long-term Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation
United States844 participantsStarted 2011-04
Plain-language 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.
Who can participate
Age range18 Years – 84 Years
SexALL
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Inclusion Criteria:
* Provision of written informed consent prior to any study-specific procedures.
* NEW PATIENTS ONLY: Self-reported active symptoms of OIC at screening (\<3 SBMs/week and experiencing \>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.
What they're measuring
1
Incidence of Patients Experiencing at Least One Adverse Event (AE)
Timeframe: Baseline (Week 0) to end of the follow-up period
2
Incidence of Patients Experiencing AEs That Resulted in Discontinuation of Investigational Product (IP)
Timeframe: Baseline (Week 0) to end of the follow-up period
3
Incidence of Patients Experiencing Severe Adverse Events (SAEs)
Timeframe: Baseline (Week 0) to end of the follow-up period