Efficacy and Safety of Naldemedine in the Treatment of Opioid-induced Constipation | Not Recruiting
Efficacy and Safety of Naldemedine in the Treatment of Opioid-induced Constipation
Health Conditions
  • Opioid-induced Constipation
Not Recruiting
Recruitment Status
NCT01965158
Primary Trial ID Number
Summary
The purpose of this study is to evaluate the efficacy and safety of naldemedine in the treatment of opioid-induced constipation (OIC) in subjects with non-malignant chronic pain who are not using laxatives
Primary Outcome Measures
  • Proportion of responders; 12 week treatment period
Secondary Outcome Measures
    Sorry, this information is not available
Research Question
  • The purpose of this study is to evaluate the efficacy and safety of naldemedine in the treatment of opioid-induced constipation (OIC) in subjects with non-malignant chronic pain who are not using laxatives
Design Type
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Ethics Approval
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Publications
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Countries of Recruitment
United States; Austria; Czech Republic; Germany; Poland; Spain; United Kingdom
Participant Sex
Both
Participant Age Range
18 Years to 80 Years
Participant Type
Sorry, this information is not available
Trial Sample Size
540
Participant Inclusion Criteria
  • Inclusion Criteria:
  • 1. Subjects aged 18 to 80 years inclusive at the time of informed consent
  • 2. Subjects must have non-malignant chronic pain treated with opioids and must have
  • opioid-induced constipation (OIC)
  • 3. Subjects must be treated with a stable opioid regimen at a total daily dose on
  • average of ≥ 30 mg equivalents of oral morphine sulfate
  • 4. Subjects must not be currently using laxatives or must be willing to discontinue
  • laxative use at Screening and must be willing to use only the rescue laxatives
  • provided throughout the study duration
  • 5. Subjects must meet opioid-induced constipation criteria based on the Bowel Movement
  • and Constipation Assessment (BMCA) Diary
  • Exclusion Criteria:
  • 1. Evidence of significant structural abnormalities of the gastrointestinal (GI) tract
  • 2. Evidence of active medical diseases affecting bowel transit
  • 3. History or presence of pelvic disorders that may be a cause of constipation
  • 4. Surgery (except for minor procedures) within 60 days of Screening
  • 5. History of chronic constipation prior to starting analgesic medication or any
  • potential non-opioid cause of bowel dysfunction that may be a major contributor to
  • the constipation (e.g., mechanical GI obstruction)
  • 6. Subjects who have never taken laxatives for the treatment of OIC
  • 7. History of active treatment for cancer within the last 2 years (except for basal cell
  • or squamous cell carcinoma of the skin that have been successfully resected) or
  • tamoxifen [Nolvadex®] and raloxifene [Evista®] when being used for prevention of
  • breast cancer
  • 8. Current use of any prohibited medication including opioid antagonists, partial
  • agonists or mixed agonists/antagonists
Participant Exclusion Criteria
  • Inclusion Criteria:
  • 1. Subjects aged 18 to 80 years inclusive at the time of informed consent
  • 2. Subjects must have non-malignant chronic pain treated with opioids and must have
  • opioid-induced constipation (OIC)
  • 3. Subjects must be treated with a stable opioid regimen at a total daily dose on
  • average of ≥ 30 mg equivalents of oral morphine sulfate
  • 4. Subjects must not be currently using laxatives or must be willing to discontinue
  • laxative use at Screening and must be willing to use only the rescue laxatives
  • provided throughout the study duration
  • 5. Subjects must meet opioid-induced constipation criteria based on the Bowel Movement
  • and Constipation Assessment (BMCA) Diary
  • Exclusion Criteria:
  • 1. Evidence of significant structural abnormalities of the gastrointestinal (GI) tract
  • 2. Evidence of active medical diseases affecting bowel transit
  • 3. History or presence of pelvic disorders that may be a cause of constipation
  • 4. Surgery (except for minor procedures) within 60 days of Screening
  • 5. History of chronic constipation prior to starting analgesic medication or any
  • potential non-opioid cause of bowel dysfunction that may be a major contributor to
  • the constipation (e.g., mechanical GI obstruction)
  • 6. Subjects who have never taken laxatives for the treatment of OIC
  • 7. History of active treatment for cancer within the last 2 years (except for basal cell
  • or squamous cell carcinoma of the skin that have been successfully resected) or
  • tamoxifen [Nolvadex®] and raloxifene [Evista®] when being used for prevention of
  • breast cancer
  • 8. Current use of any prohibited medication including opioid antagonists, partial
  • agonists or mixed agonists/antagonists
Interventions
Drug; Naldemedine; Naldemedine tablet from weeks 1-12; [Subjects on naldemedine]; Drug; Placebo; Placebo tablet from weeks 1-12; [Subjects on placebo]
Design Details
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Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Results Reporting
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Acronym
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Scientific Title
A Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Naldemedine in the Treatment of Opioid-induced Constipation in Subjects With Non-malignant Chronic Pain Receiving Opioid Therapy
Secondary Trial Identifying Number
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Website
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Study Funded By
Shionogi
Funder Type
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Study Sponsored By
Shionogi
Study Also Sponsored By
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Primary Sponsor Type
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Secondary Sponsor Type
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Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

30 Sep 2013

Last Updated

17 Feb 2015

Date Record Refreshed on UKCTG

31 Jul 2015