Assessment of Long-term Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation

Study Overview
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Brief Summary
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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.

Official Title
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An Open-Label 52-week Study to Assess the Long-Term Safety of NKTR-118 in Opioid-Induced Constipation (OIC) in Patients With Non-Cancer-Related Pain

Conditions
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Opioid-Induced Constipation (OIC)

Intervention / Treatment
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* Drug: NKTR-118
* Drug: Usual care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 84 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Oral Treatment | Drug: NKTR-118<br>* 25 mg oral tablet once daily<br>|
| Active Comparator: 2<br>Oral treatment | Drug: Usual care<br>* As prescribed by the investigator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Patients Experiencing at Least One Adverse Event (AE) | The incidence of patients experiencing at least one AE during the randomized treatment and follow-up periods was calculated. | Baseline (Week 0) to end of the follow-up period | 
| Incidence of Patients Experiencing AEs That Resulted in Discontinuation of Investigational Product (IP) | The incidence of patients experiencing AEs that resulted in discontinuation of IP during the randomized treatment or follow-up periods was calculated. | Baseline (Week 0) to end of the follow-up period | 
| Incidence of Patients Experiencing Severe Adverse Events (SAEs) | The incidence of patients experiencing SAEs during the randomized treatment and follow-up periods was calculated. | Baseline (Week 0) to end of the follow-up period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-Cancer-Related Pain, Opioid-Induced Constipation