Clinical trial NCT01336205: Assessment of Long-term Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Opioid-Induced Constipation (OIC)
Keywords: Non-Cancer-Related Pain
Opioid-Induced Constipation
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-04-15
Enrollment: 844
Sex: ALL
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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 (\<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.

Primary outcomes:
measure: Incidence of Patients Experiencing at Least One Adverse Event (AE)
timeFrame: Baseline (Week 0) to end of the follow-up period
measure: Incidence of Patients Experiencing AEs That Resulted in Discontinuation of Investigational Product (IP)
timeFrame: Baseline (Week 0) to end of the follow-up period
measure: Incidence of Patients Experiencing Severe Adverse Events (SAEs)
timeFrame: Baseline (Week 0) to end of the follow-up period
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: United States
facility: Research Site
state: Alabama
city: Birmingham
country: United States
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state: Alabama
city: Huntsville
country: United States
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state: Alabama
city: Mobile
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state: Alabama
city: Pell City
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city: Beavercreek
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city: Centerville
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city: Toledo
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city: Oklahoma City
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city: Jenkintown
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city: Norristown
country: United States
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city: Philadelphia
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city: Pottstown
country: United States
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city: Anderson
country: United States
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state: South Carolina
city: Charleston
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state: South Carolina
city: Greer
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city: Myrtle Beach
country: United States
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state: South Carolina
city: Chattanooga
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state: Tennessee
city: Clarksville
country: United States
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state: Tennessee
city: Jackson
country: United States
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state: Tennessee
city: Memphis
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state: Tennessee
city: Milan
country: United States
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state: Tennessee
city: New Tazewell
country: United States
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state: Tennessee
city: Austin
country: United States
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state: Texas
city: Dallas
country: United States
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state: Texas
city: Houston
country: United States
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state: Texas
city: Hurst
country: United States
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city: Lexington
country: United States
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state: Texas
city: Marshall
country: United States
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state: Texas
city: San Antonio
country: United States
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state: Texas
city: Sugarland
country: United States
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state: Texas
city: Victoria
country: United States
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state: Texas
city: Clinton
country: United States
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state: Utah
city: Ogden
country: United States
facility: Research Site
state: Utah
city: Saint George
country: United States
facility: Research Site
state: Utah
city: Salt Lake City
country: United States
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state: Utah
city: West Jordan
country: United States
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state: Utah
city: Richmond
country: United States
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state: Virginia
city: Springfield
country: United States
facility: Research Site
state: Virginia
city: Virginia Beach
country: United States
facility: Research Site
state: Virginia
city: Middleton
country: United States
facility: Research Site
state: Wisconsin
Study officials:
affiliation: AstraZeneca
name: Mark Sostek
role: STUDY_DIRECTOR
References:
citation: Webster L, Chey WD, Tack J, Lappalainen J, Diva U, Sostek M. Randomised clinical trial: the long-term safety and tolerability of naloxegol in patients with pain and opioid-induced constipation. Aliment Pharmacol Ther. 2014 Oct;40(7):771-9. doi: 10.1111/apt.12899. Epub 2014 Aug 12.