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

Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Opioid-induced Constipation
Unfortunately contact details are not available for this trial.
Primary Contact Details
Not Recruiting
Recruitment Status
Primary Trial ID Number
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
Research Details
  • This is a Phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of naldemedine 0.2 mg once daily versus placebo for the treatment of subjects with non-malignant chronic pain and OIC
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Study Type
Drug : Naldemedine, Drug : Placebo

Study Arm Groups : Subjects on naldemedine, Subjects on placebo

Intervention Type
See Interventions above
Primary Outcome Measures
  • Proportion of responders; 12 week treatment period
Secondary Outcome Measures
    Sorry, this information is not available
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
Age Range
18 Years - 80 Years
Who Can Participate
Number of Participants
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
This is in the inclusion criteria above
Trial Location(s)
Ulster Hospital
Shionogi Research Site
Penzance Cornwall
Shionogi Research Site
Bexhill-on-Sea East Sussex
Shionogi Research Site
Fowey Cornwall
Shionogi Research Site
Liskeard Cornwall
Shionogi Research Site
Crownhill Plymouth
Shionogi Research Site
Soham Ely Cambs
Shionogi Research Site
St Austell Cornwall
Shionogi Research Site
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Austria, Czech Republic, Germany, Poland, Spain, United Kingdom, United States
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
EudraCT Number
Not available for this trial
    Sorry, this information is not available
Other Study ID Numbers
Key Dates

Recruitment Start Date

Aug 2013

Recruitment End Date

Jul 2015

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

30 Sep 2013

Last Updated

17 Feb 2015