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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01336205
Recruitment Status : Completed
First Posted : April 15, 2011
Results First Posted : October 20, 2014
Last Update Posted : October 20, 2014
Information provided by (Responsible Party):

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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 844 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : April 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation
Drug Information available for: Naloxegol
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 84 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01336205

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Sponsors and Collaborators
Study Director: Mark Sostek AstraZeneca

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: AstraZeneca Identifier: NCT01336205     History of Changes
Other Study ID Numbers: D3820C00008
First Posted: April 15, 2011    Key Record Dates
Results First Posted: October 20, 2014
Last Update Posted: October 20, 2014
Last Verified: October 2014

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

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists