Assessment of Efficacy and 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:
NCT01309841
First received: March 4, 2011
Last updated: August 29, 2012
Last verified: August 2012
  Purpose

The purpose of this study is to evaluate the effect and safety of NKTR-118 treatment of opioid-induced constipation in patients with non-cancer-related pain, including those patients that have inadequate response to laxative therapy (LIR).


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NKTR-118 in Patients With Non-Cancer-Related Pain and Opioid-Induced Constipation (OIC)

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • The primary efficacy endpoint is response (responder/non-responder) to study drug during Weeks 1 to 12, for at least 9 out of 12 weeks, and at least 3 out of the last 4 weeks. [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: No ]
    Responder is defined as having at least 3 SBMs/week with at least 1 SBM/week increase over baseline.


Secondary Outcome Measures:
  • Response (responder/non-responder) to study drug in the LIR subgroup during Weeks 1 to 12, for at least 9 out of 12 weeks and at least 3 out of the last 4 weeks. [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
    Responder is defined as having at least 3 SBMs/week, with at least 1 SBM/week increase over baseline.

  • Time (in hours) to first post-dose laxation without the use of rescue laxatives within the previous 24 hours. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Mean number of days per week with at least 1 SBM during Weeks 1 to 12. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 652
Study Start Date: March 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Oral treatment
Drug: NKTR-118
12.5 mg oral tablet once daily
Experimental: 2
Oral treatment
Drug: NKTR-118
25 mg oral tablet once daily
Placebo Comparator: 3
Oral treatment
Drug: Placebo
Oral tablet once daily

  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.
  • Men and women who are between the ages of ≥18 and <85 years.
  • 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 BMs over the previous 4 weeks); and Documented confirmed OIC (<3 SBMs/week on average over the 2-week OIC confirmation period.
  • Receiving a stable maintenance opioid regimen consisting of a total daily dose of 30 mg to 1000 mg of oral morphine, or equianalgesic amount(s) of 1 or more other opioid therapies for a minimum of 4 weeks prior to screening for non-cancer-related pain with no anticipated change in opioid dose requirement over the proposed study period as a result of disease progression.
  • Willingness to stop all laxatives and other bowel regimens including prune juice and herbal products throughout the 2-week OIC confirmation period and the 12-week treatment period, and to use only bisacodyl as rescue medication if a 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 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: NCT01309841

  Show 117 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Mark Sostek AstraZeneca Pharmaceuticals, Wilm DE
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01309841     History of Changes
Other Study ID Numbers: D3820C00004, 2011-001987-24
Study First Received: March 4, 2011
Last Updated: August 29, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Germany: Federal Institute for Drugs and Medical Devices
Slovakia: State Institute for Drug Control
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, Digestive
Signs and Symptoms
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants

ClinicalTrials.gov processed this record on July 22, 2014