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

Phase 3

Completed

• Conditions: Opioid-Induced Constipation (OIC)
• Interventions: Drug: NKTR-118; Drug: Usual care

• Registration Number: NCT01336205
• Lead Sponsor: AstraZeneca

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-14
• Study First Submitted QC: 2011-04-14
• Study First Posted: 2011-04-15
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2014-10
• Results First Submitted: 2014-10-13
• Results First Submitted QC: 2014-10-13
• Last Update Submitted: 2014-10-13
• Results First Posted: 2014-10-20
• Last Update Posted: 2014-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 844

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	NKTR-118	Oral Treatment
2	Usual care	Oral treatment

Primary Outcome Measures

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

Trial Locations

Locations (1)

Research Site; 🇺🇸 Middleton, Wisconsin, United States