A Study of Naldemedine (S-297995) for the Treatment of Opioid-Induced Constipation in Adults With Non-Malignant Chronic Pain Receiving Opioid Therapy
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of S-297995 for the Treatment of Opioid-Induced Constipation in Subjects With Non-Malignant Chronic Pain Receiving Opioid Therapy
1 other identifier
interventional
244
1 country
49
Brief Summary
The purpose of this study is to determine efficacy and safety of naldemedine for the treatment of opioid-induced constipation in adults with non-malignant chronic pain receiving opioid therapy for ≥ 3 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2011
Shorter than P25 for phase_2
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 17, 2011
CompletedFirst Submitted
Initial submission to the registry
September 20, 2011
CompletedFirst Posted
Study publicly available on registry
September 29, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 22, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 22, 2012
CompletedResults Posted
Study results publicly available
May 30, 2017
CompletedJune 26, 2017
May 1, 2017
1 year
September 20, 2011
April 19, 2017
May 31, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline to Last 2 Weeks of the Treatment Period in the Number of Spontaneous Bowel Movements Per Week
Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation. A spontaneous bowel movement was defined as a bowel movement unassisted by rescue medication (laxative or enema) taken within the 24 hours preceding the bowel movement. Baseline was defined as the average number of SBMs per week during the 2 weeks prior to randomization. The number of SBMs per week in the last 2 weeks of treatment is defined as the average number of SBMs per week recorded in the diary for the 14 days prior to the last dose of study drug.
Baseline (2 weeks prior to randomization) and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)
Secondary Outcomes (35)
Change From Baseline to Weeks 1, 2, 3, and 4 in the Number of Spontaneous Bowel Movements Per Week
Baseline and Weeks 1, 2, 3, and 4
Change From Baseline to the Last 2 Weeks of the Treatment Period in the Number of Bowel Movements (BMs) Per Week
Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)
Change From Baseline to Weeks 1, 2, 3, and 4 in the Number of Bowel Movements Per Week
Baseline and Weeks 1, 2, 3, and 4
Change From Baseline to the Last 2 Weeks of the Treatment Period in the Number of Complete Bowel Movements (CBMs) Per Week
Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)
Change From Baseline to Weeks 1, 2, 3, and 4 in the Number of Complete Bowel Movements Per Week
Baseline and Weeks 1, 2, 3, and 4
- +30 more secondary outcomes
Study Arms (4)
Placebo
PLACEBO COMPARATORParticipants received placebo orally once daily for 28 days.
Naldemedine 0.1 mg
EXPERIMENTALParticipants received 0.1 mg naldemedine orally once daily for 28 days.
Naldemedine 0.2 mg
EXPERIMENTALParticipants received 0.2 mg naldemedine orally once daily for 28 days.
Naldemedine 0.4 mg
EXPERIMENTALParticipants received 0.4 mg naldemedine orally once daily for 28 days.
Interventions
Naldemedine tablets administered orally once a day.
Eligibility Criteria
You may qualify if:
- Subjects aged 18 years or older at time of informed consent with non-malignant chronic pain experiencing opioid-induced constipation
- Subjects with \< 3 spontaneous bowel movements a week and experiencing bowel symptoms
- Subjects receiving chronic opioid therapy due to non-malignant pain for ≥ 3 months
You may not qualify if:
- Evidence of clinically significant gastrointestinal disease
- 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
- Severe constipation that has not been appropriately managed such that the subject is at immediate risk of developing serious complications of constipation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shionogilead
Study Sites (49)
Shionogi Research Site
Phoenix, Arizona, United States
Shionogi Research Site
Sun Lakes, Arizona, United States
Shionogi Research Site
Little Rock, Arkansas, United States
Shionogi Research Site
Anaheim, California, United States
Shionogi Research Site
Fresno, California, United States
Shionogi Research Site
Lincoln, California, United States
Shionogi Research Site
Lomita, California, United States
Shionogi Research Site
Denver, Colorado, United States
Shionogi Research Site
Brandon, Florida, United States
Shionogi Research Site
Kissimmee, Florida, United States
Shionogi Research Site
New Port Richey, Florida, United States
Shionogi Research Site
North Miami, Florida, United States
Shionogi Research Site
Ocala, Florida, United States
Shionogi Research Site
Orlando, Florida, United States
Shionogi Research Site
Ormond Beach, Florida, United States
Shionogi Research Site
Port Orange, Florida, United States
Shionogi Research Site
Sarasota, Florida, United States
Shionogi Research Site
South Miami, Florida, United States
Shionogi Research Site
West Palm Beach, Florida, United States
Shionogi Research Site
Atlanta, Georgia, United States
Shionogi Research Site
Decatur, Georgia, United States
Shionogi Research Site
Marietta, Georgia, United States
Shionogi Research Site
Evansville, Indiana, United States
Shionogi Research Site
Lexington, Kentucky, United States
Shionogi Research Site
Shreveport, Louisiana, United States
Shionogi Research Site
Owings Mills, Maryland, United States
Shionogi Research Site
Watertown, Massachusetts, United States
Shionogi Research Site
Worcester, Massachusetts, United States
Shionogi Research Site
Traverse City, Michigan, United States
Shionogi Research Site
Edina, Minnesota, United States
Shionogi Research Site
Las Vegas, Nevada, United States
Shionogi Research Site
Newington, New Hampshire, United States
Shionogi Research Site
Berlin, New Jersey, United States
Shionogi Research Site
Willingboro, New Jersey, United States
Shionogi Research Site
Hartsdale, New York, United States
Shionogi Research Site
North Syracuse, New York, United States
Shionogi Research Site
Williamsville, New York, United States
Shionogi Research Site
Wilmington, North Carolina, United States
Shionogi Research Site
Winston-Salem, North Carolina, United States
Shionogi Research Site
Canton, Ohio, United States
Shionogi Research Site
Columbus, Ohio, United States
Shionogi Research Site
Perrysburg, Ohio, United States
Shionogi Research Site
Eugene, Oregon, United States
Shionogi Research Site
Philadelphia, Pennsylvania, United States
Shionogi Research Site
Greer, South Carolina, United States
Shionogi Research Site
Austin, Texas, United States
Shionogi Research Site
Dallas, Texas, United States
Shionogi Research Site
Orem, Utah, United States
Shionogi Research Site
Salt Lake City, Utah, United States
Related Publications (1)
Webster LR, Yamada T, Arjona Ferreira JC. A Phase 2b, Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Naldemedine for the Treatment of Opioid-Induced Constipation in Patients with Chronic Noncancer Pain. Pain Med. 2017 Dec 1;18(12):2350-2360. doi: 10.1093/pm/pnw325.
PMID: 28371937RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Shionogi Clinical Trials Administrator
- Organization
- Shionogi Inc.
Study Officials
- STUDY DIRECTOR
Shionogi Clinical Trials Administrator Clinical Support Help Line
Shionogi
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2011
First Posted
September 29, 2011
Study Start
August 17, 2011
Primary Completion
August 22, 2012
Study Completion
August 22, 2012
Last Updated
June 26, 2017
Results First Posted
May 30, 2017
Record last verified: 2017-05