Long Term Safety of Naldemedine

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Shionogi Inc.
Sponsor:
Information provided by (Responsible Party):
Shionogi Inc. ( Shionogi )
ClinicalTrials.gov Identifier:
NCT01965652
First received: October 15, 2013
Last updated: November 19, 2013
Last verified: November 2013
  Purpose

The purpose of this study is to evaluate the long-term safety of naldemedine for the treatment of constipation due to opioid therapy.


Condition Intervention Phase
Opioid-induced Constipation
Drug: Naldemedine
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Double-blind, Placebo-controlled, Parallel-group, Multicenter, Phase 3 Study to Evaluate the Long-term Safety of Naldemedine for the Treatment of Opioid-induced Constipation in Subjects With Non-malignant Chronic Pain Receiving Opioid Therapy

Resource links provided by NLM:


Further study details as provided by Shionogi Inc.:

Primary Outcome Measures:
  • Number of Major Adverse Cardiac Events (MACE) [ Time Frame: Baseline to end of 52 week treatment period ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1500
Study Start Date: August 2013
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Subjects on naldemedine
Subjects will receive a single tablet of naldemedine once daily for the duration of the 52 week treatment period
Drug: Naldemedine
Naldemedine tablet from weeks 1-52
Subjects on placebo
Subjects will receive a single tablet of placebo once daily for the duration of the 52 week treatment period
Drug: Placebo
Placebo tablet from weeks 1-52

Detailed Description:

This is a Phase 3, multi-center, randomized double-blind, placebo controlled, parallel-group study designed to evaluate the cardiovascular safety of naldemedine compared to placebo for the treatment of opioid-induced constipation (OIC) in subjects with non-malignant chronic pain receiving opioid therapy.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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 may or may not be on a routine laxative regimen at the time of Screening

Exclusion Criteria

  1. Evidence of significant structural abnormalities of the gastrointestinal (GI) tract
  2. Evidence of active medical diseases affecting bowel transit
  3. History 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. Current use of any prohibited medication including opioid antagonists, partial or mixed agonists/antagonists
  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: NCT01965652

Contacts
Contact: Shionogi Clinical Trials Administrator Clinical Support Help Line 800-849-9707 ext 1454 shionogiclintrialsadmin@shionogi.com

  Show 186 Study Locations
Sponsors and Collaborators
Shionogi
Investigators
Study Director: Shionogi Clinical Trials Administrator Clinical Support Help Line Shionogi
  More Information

No publications provided

Responsible Party: Shionogi Inc. ( Shionogi )
ClinicalTrials.gov Identifier: NCT01965652     History of Changes
Other Study ID Numbers: 1326V9235
Study First Received: October 15, 2013
Last Updated: November 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Shionogi Inc.:
Opioid Induced Constipation

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

ClinicalTrials.gov processed this record on September 29, 2014