Efficacy and Safety of Naldemedine in the Treatment of Opioid-induced Constipation
NCT ID: NCT01965158
Last Updated: 2017-05-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
547 participants
INTERVENTIONAL
2013-08-29
2015-01-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Naldemedine
Participants received 0.2 mg naldemedine orally once daily for 12 weeks.
Naldemedine
Naldemedine 0.2 mg tablet taken orally once a day
Placebo
Participants received matching placebo orally once daily for 12 weeks.
Placebo
Placebo tablet taken orally once a day
Interventions
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Naldemedine
Naldemedine 0.2 mg tablet taken orally once a day
Placebo
Placebo tablet taken orally once a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
80 Years
ALL
No
Sponsors
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Shionogi
INDUSTRY
Responsible Party
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Principal Investigators
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Shionogi Clinical Trials Administrator Clinical Support Help Line
Role: STUDY_DIRECTOR
Shionogi
Locations
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Shionogi Research Site
Birmingham, Alabama, United States
Shionogi Research Site
Phoenix, Arizona, United States
Shionogi Research Site
Fresno, California, United States
Shionogi Research Site
Long Beach, California, United States
Shionogi Research Site
National City, California, United States
Shionogi Research Site
North Hollywood, California, United States
Shionogi Research Site
Oceanside, California, United States
Shionogi Research Site
Golden, Colorado, United States
Shionogi Research Site
Miami, Florida, United States
Shionogi Research Site
Miami Springs, Florida, United States
Shionogi Research Site
Orlando, Florida, United States
Shionogi Research Site
Sarasota, Florida, United States
Shionogi Research Site
West Palm Beach, Florida, United States
Shionogi Research Site
Winter Park, Florida, United States
Shionogi Research Site
Marietta, Georgia, United States
Shionogi Research Site
Shreveport, Louisiana, United States
Shionogi Research Site
Caro, Michigan, United States
Shionogi Research Site
Flint, Michigan, United States
Shionogi Research Site
Hazelwood, Missouri, United States
Shionogi Research Site
Las Vegas, Nevada, United States
Shionogi Research Site
Belvidere, New Jersey, United States
Shionogi Research Site
East Brunswick, New Jersey, United States
Shionogi Research Site
Albuquerque, New Mexico, United States
Shionogi Research Site
Great Neck, New York, United States
Shionogi Research Site
Hollis, New York, United States
Shionogi Research Site
New Windsor, New York, United States
Shionogi Research Site
Winston-Salem, North Carolina, United States
Shionogi Research Site
Cincinnati, Ohio, United States
Shionogi Research Site
Oklahoma City, Oklahoma, United States
Shionogi Research Site
Medford, Oregon, United States
Shionogi Research Site
West Reading, Pennsylvania, United States
Shionogi Research Site
Chattanooga, Tennessee, United States
Shionogi Research Site
Arlington, Texas, United States
Shionogi Research Site
Austin, Texas, United States
Shionogi Research Site
Dallas, Texas, United States
Shionogi Research Site
Houston, Texas, United States
Shionogi Research Site
San Antonio, Texas, United States
Shionogi Research Site
Sankt Pölten, , Austria
Shionogi Research Site
Vienna, , Austria
Shionogi Research Site
Hradec Králové, , Czechia
Shionogi Research Site
Liberec, , Czechia
Shionogi Research Site
Pardubice, , Czechia
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Prague, , Czechia
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Vysoké Mýto, , Czechia
Shionogi Research Site
Berlin, , Germany
Shionogi Research Site
Eichstätt, , Germany
Shionogi Research Site
Frankfurt am Main, , Germany
Shionogi Research Site
Bialystok, , Poland
Shionogi Research Site
Bydgoszcz, , Poland
Shionogi Research Site
Czeladź, , Poland
Shionogi Research Site
Gorzów Wielkopolski, , Poland
Shionogi Research Site
Warsaw, , Poland
Shionogi Research Site
Alicante, , Spain
Shionogi Research Site
Cadiz, , Spain
Shionogi Research Site
Madrid, , Spain
Shionogi Research Site
Belfast, , United Kingdom
Shionogi Research Site
Bexhill-on-Sea East Sussex, , United Kingdom
Shionogi Research Site
Crownhill Plymouth, , United Kingdom
Shionogi Research Site
Fowey Cornwall, , United Kingdom
Shionogi Research Site
Liskeard Cornwall, , United Kingdom
Shionogi Research Site
London, , United Kingdom
Shionogi Research Site
Penzance Cornwall, , United Kingdom
Shionogi Research Site
Saint Austell Cornwall, , United Kingdom
Shionogi Research Site
Soham Ely Cambs, , United Kingdom
Shionogi Research Site
Tomairt, , United Kingdom
Countries
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References
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Hale ME, Wild JE, Yamada T, Yokota T, Tack J, Andresen V, Drewes AM. Naldemedine is effective in the treatment of opioid-induced constipation in patients with chronic non-cancer pain who had a poor response to laxatives. Therap Adv Gastroenterol. 2021 Jul 31;14:17562848211032320. doi: 10.1177/17562848211032320. eCollection 2021.
Camilleri M, Hale M, Morlion B, Tack J, Webster L, Wild J. Naldemedine Improves Patient-Reported Outcomes of Opioid-Induced Constipation in Patients with Chronic Non-Cancer Pain in the COMPOSE Phase 3 Studies. J Pain Res. 2021 Jul 16;14:2179-2189. doi: 10.2147/JPR.S282738. eCollection 2021.
Tack J, Camilleri M, Hale M, Morlion B, Nalamachu S, Webster L, Wild J. Establishing Minimal Clinically Important Differences in Quality of Life Measures in Opioid-Induced Constipation. Clin Gastroenterol Hepatol. 2022 Apr;20(4):855-863. doi: 10.1016/j.cgh.2021.05.004. Epub 2021 Aug 5.
Webster LR, Hale ME, Yamada T, Wild JE. A Renal Impairment Subgroup Analysis of the Safety and Efficacy of Naldemedine for the Treatment of Opioid-Induced Constipation in Patients with Chronic Non-Cancer Pain Receiving Opioid Therapy. J Pain Res. 2020 Mar 24;13:605-612. doi: 10.2147/JPR.S237833. eCollection 2020.
Wild J, Webster L, Yamada T, Hale M. Safety and Efficacy of Naldemedine for the Treatment of Opioid-Induced Constipation in Patients with Chronic Non-Cancer Pain Receiving Opioid Therapy: A Subgroup Analysis of Patients >/= 65 Years of Age. Drugs Aging. 2020 Apr;37(4):271-279. doi: 10.1007/s40266-020-00753-2.
Wild J, Yamada T, Arjona Ferreira JC, Hale M. Onset of action of naldemedine in the treatment of opioid-induced constipation in patients with chronic noncancer pain: results from 2 randomized, placebo-controlled, phase 3 trials. Pain. 2019 Oct;160(10):2358-2364. doi: 10.1097/j.pain.0000000000001629.
Hale M, Wild J, Reddy J, Yamada T, Arjona Ferreira JC. Naldemedine versus placebo for opioid-induced constipation (COMPOSE-1 and COMPOSE-2): two multicentre, phase 3, double-blind, randomised, parallel-group trials. Lancet Gastroenterol Hepatol. 2017 Aug;2(8):555-564. doi: 10.1016/S2468-1253(17)30105-X. Epub 2017 May 30.
Other Identifiers
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2013-002241-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1314V9231
Identifier Type: -
Identifier Source: org_study_id
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