Efficacy and Safety of Naldemedine in Treating Opioid-induced Constipation
NCT ID: NCT01993940
Last Updated: 2017-05-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
553 participants
INTERVENTIONAL
2013-11-04
2015-06-09
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
* Subjects must have non-malignant chronic pain treated with opioids and must have opioid-induced constipation (OIC)
* Subjects must be treated with a stable opioid regimen at a total daily dose on average of ≥ 30 mg equivalents of oral morphine sulfate
* 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
* Subjects must meet opioid-induced constipation criteria based on the Bowel Movement and Constipation Assessment (BMCA) Diary
Exclusion Criteria
* Evidence of active medical diseases affecting bowel transit
* History or presence of pelvic disorders that may be a cause of constipation
* Surgery (except for minor procedures) within 60 days of Screening
* 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)
* Subjects who have never taken laxatives for the treatment of OIC
* 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
* 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
Homewood, Alabama, United States
Shionogi Research Site
Goodyear, Arizona, United States
Shionogi Research Site
Little Rock, Arkansas, United States
Shionogi Research Site
Anaheim, California, United States
Shionogi Research Site
Buena Park, California, United States
Shionogi Research Site
Corona, California, United States
Shionogi Research Site
Gold River, California, United States
Shionogi Research Site
Los Angeles, California, United States
Shionogi Research Site
Modesto, California, United States
Shionogi Research Site
Pasadena, California, United States
Shionogi Research Site
Coral Gables, Florida, United States
Shionogi Research Site
Hialeah, Florida, United States
Shionogi Research Site
Jacksonville, Florida, United States
Shionogi Research Site
Miami, Florida, United States
Shionogi Research Site
Miami Beach, Florida, United States
Shionogi Research Site
Plantation, Florida, United States
Shionogi Research Site
Columbus, Georgia, United States
Shionogi Research Site
Evansville, Indiana, United States
Shionogi Research Site
Indianapolis, Indiana, United States
Shionogi Research Site
West Des Moines, Iowa, United States
Shionogi Research Site
Edgewood, Kentucky, United States
Shionogi Research Site
Crowley, Louisiana, United States
Shionogi Research Site
Kalamazoo, Michigan, United States
Shionogi Research Site
Traverse City, Michigan, United States
Shionogi Research Site
Butte, Montana, United States
Shionogi Research Site
Omaha, Nebraska, United States
Shionogi Research Site
Las Vegas, Nevada, United States
Shionogi Research Site
Omaha, Nevada, United States
Shionogi Research Site
Albuquerque, New Mexico, United States
Shionogi Research Site
Hopewell Junction, New York, United States
Shionogi Research Site
Mooresville, North Carolina, United States
Shionogi Research Site
Winston-Salem, North Carolina, United States
Shionogi Research Site
Dayton, Ohio, United States
Shionogi Research Site
Marion, Ohio, United States
Shionogi Research Site
Media, Pennsylvania, United States
Shionogi Research Site
Spartanburg, South Carolina, United States
Shionogi Research Site
Knoxville, Tennessee, United States
Shionogi Research Site
Tullahoma, Tennessee, United States
Shionogi Research Site
Channelview, Texas, United States
Shionogi Research Site
Fort Worth, Texas, United States
Shionogi Research Site
Groesbeck, Texas, United States
Shionogi Research Site
Houston, Texas, United States
Shionogi Research Site
Plano, Texas, United States
Shionogi Research Site
San Antonio, Texas, United States
Shionogi Research Site
Chesapeake, Virginia, United States
Shionogi Research Site
Chester, Virginia, United States
Shionogi Research Site
Tacoma, Washington, United States
Shionogi Research Site
Clarksburg, West Virginia, United States
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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2013-002948-91
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1315V9232
Identifier Type: -
Identifier Source: org_study_id
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