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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01336205
First received: April 14, 2011
Last updated: October 13, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Opioid-Induced Constipation (OIC)
Drug: NKTR-118
Drug: Usual care
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Incidence of Patients Experiencing at Least One Adverse Event (AE) [ Time Frame: Baseline (Week 0) to end of the follow-up period ] [ Designated as safety issue: Yes ]
    The incidence of patients experiencing at least one AE during the randomized treatment and follow-up periods was calculated.

  • 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 ] [ Designated as safety issue: Yes ]
    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 Severe Adverse Events (SAEs) [ Time Frame: Baseline (Week 0) to end of the follow-up period ] [ Designated as safety issue: Yes ]
    The incidence of patients experiencing SAEs during the randomized treatment and follow-up periods was calculated.


Enrollment: 844
Study Start Date: April 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Oral Treatment
Drug: NKTR-118
25 mg oral tablet once daily
Active Comparator: 2
Oral treatment
Drug: Usual care
As prescribed by the investigator

  Eligibility

Ages Eligible for Study:   18 Years to 84 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01336205

  Show 170 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Mark Sostek AstraZeneca
  More Information

Additional Information:
No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01336205     History of Changes
Other Study ID Numbers: D3820C00008
Study First Received: April 14, 2011
Results First Received: October 13, 2014
Last Updated: October 13, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Non-Cancer-Related Pain
Opioid-Induced Constipation

Additional relevant MeSH terms:
Constipation
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on October 23, 2014