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Completed

NCT Number: NCT01336205

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

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.

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Key information

Conditions

Opioid-induced Constipation (OIC) Chemically-Induced Disorders Constipation Mental Disorders Narcotic-Related Disorders Opioid-Induced Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Substance-Related Disorders

Age range

18 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Athens, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NKTR-118

Drug

25 mg oral tablet once daily

Usual Care

Drug

As prescribed by the investigator

Primary outcomes

  1. Incidence of Patients Experiencing at Least One Adverse Event (AE)

    Time frame: 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.

  2. Incidence of Patients Experiencing AEs That Resulted in Discontinuation of Investigational Product (IP)

    Time frame: 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.

  3. Incidence of Patients Experiencing Severe Adverse Events (SAEs)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 15, 2011
Registry last updated
Oct 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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