To Evaluate Patient Preference of Movantik and Polyethylene Glycol 3350 for Opioid Induced Constipation
NCT ID: NCT03060512
Last Updated: 2018-07-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
276 participants
INTERVENTIONAL
2017-03-02
2017-08-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Crossover Group 1
Crossover Group Movantik to Polyethylene Glycol 3350
2-period, 2-treatment cross-over model: Subjects will be randomized to Movantik during Treatment period 1 (2 weeks), then crossed over to receive Polyethylene Glycol 3350 for Treatment period 2 (2 weeks) after 1 week washout.
Polyethylene Glycol 3350
Polyethylene Glycol 3350, 17 grams of powder to be dissolved in 4 to 8 ounces of water, juice, soda, coffee or tea to be taken once a day.
Bisacodyl 5mg, 1-3 tablets may be taken by subject who does not experience a bowel movement within 72 hours.
Movantik
Movantik 25 mg, 1 tablet taken once a day on an empty stomach at least 1 hour prior to the first meal of the day or 2 hours after the meal.
Bisacodyl 5mg, 1-3 tablets may be taken by subject who does not experience a bowel movement within 72 hours.
Crossover Group 2
Crossover group Polyethylene Glycol 3350 to Movantik
2-period, 2-treatment cross-over model: Subjects will be randomized to Polyethylene Glycol 3350 during Treatment period 1 (2 weeks), then crossed over to receive Movantik for Treatment period 2 (2 weeks) after 1 week washout.
Polyethylene Glycol 3350
Polyethylene Glycol 3350, 17 grams of powder to be dissolved in 4 to 8 ounces of water, juice, soda, coffee or tea to be taken once a day.
Bisacodyl 5mg, 1-3 tablets may be taken by subject who does not experience a bowel movement within 72 hours.
Movantik
Movantik 25 mg, 1 tablet taken once a day on an empty stomach at least 1 hour prior to the first meal of the day or 2 hours after the meal.
Bisacodyl 5mg, 1-3 tablets may be taken by subject who does not experience a bowel movement within 72 hours.
Interventions
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Polyethylene Glycol 3350
Polyethylene Glycol 3350, 17 grams of powder to be dissolved in 4 to 8 ounces of water, juice, soda, coffee or tea to be taken once a day.
Bisacodyl 5mg, 1-3 tablets may be taken by subject who does not experience a bowel movement within 72 hours.
Movantik
Movantik 25 mg, 1 tablet taken once a day on an empty stomach at least 1 hour prior to the first meal of the day or 2 hours after the meal.
Bisacodyl 5mg, 1-3 tablets may be taken by subject who does not experience a bowel movement within 72 hours.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Self-reported active symptoms of OIC (Opioid Induced Constipation) based on components of the Rome IV criteria at screening. Patients should have at least 2 of the following:
* \<3 SBMs (Spontaneous Bowel Movements) per week
* Straining \>25% of defecations
* Sensation of incomplete evacuation \>25% of defecations
* Lumpy or hard stools \>25% of defecations
* Sensation of anorectal obstruction/blockage \>25% of defecations
* Confirmed OIC by BFI (Bowel Function Index) ≥30
* Stable maintenance opioid regimen consisting of a total daily dose of at least 30 mg of oral morphine, or equivalent of 1 or more other opioid therapies
* Willingness to stop all laxatives and other bowel regimens other than specified rescue medication
Exclusion Criteria
* Current constipation or chronic constipation not caused by or related to use of opioids
* History of rectal evacuation disorders, surgery or procedures that can potentially affect pelvic floor function; requirement of using manual maneuvers to facilitate a bowel movement
* Evidence of significant GI structural abnormalities, acute or chronic GI conditions that could post risk to the patient or confound the study results
* Recent surgery that may affect GI motility or increase risk for bowel obstruction or perforation
* Severe hepatic impairment
* Moderate or severe renal impairment
* Condition that may affect the permeability of blood-brain barrier
* Concomitantly using strong or moderate CYP3A4 inhibitors and strong CYP3A4 inducers
* Any other significant and/or progressive medical, surgical, psychiatric, or mental health condition or any significant laboratory findings that could increase the risk of participation in the study or affect the interpretation of study data as determined by the Investigator
18 Years
84 Years
ALL
No
Sponsors
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QuintilesIMS, Inc.
UNKNOWN
AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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AstraZeneca Scientific Leadership
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Huntsville, Alabama, United States
Research Site
Phoenix, Arizona, United States
Research Site
Phoenix, Arizona, United States
Research Site
Phoenix, Arizona, United States
Research Site
Anaheim, California, United States
Research Site
Anaheim, California, United States
Research Site
Lincoln, California, United States
Research Site
Los Gatos, California, United States
Research Site
North Hollywood, California, United States
Research Site
Orange, California, United States
Research Site
San Diego, California, United States
Research Site
Westminster, California, United States
Research Site
DeLand, Florida, United States
Research Site
Fort Myers, Florida, United States
Research Site
Jacksonville, Florida, United States
Research Site
Jacksonville, Florida, United States
Research Site
Jupiter, Florida, United States
Research Site
Lake City, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Miami Springs, Florida, United States
Research Site
North Miami Beach, Florida, United States
Research Site
Ormond Beach, Florida, United States
Research Site
Plantation, Florida, United States
Research Site
Port Orange, Florida, United States
Research Site
West Palm Beach, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Decatur, Georgia, United States
Research Site
Marietta, Georgia, United States
Research Site
Bloomington, Illinois, United States
Research Site
Brownsburg, Indiana, United States
Research Site
Pikesville, Maryland, United States
Research Site
Waltham, Massachusetts, United States
Research Site
Troy, Michigan, United States
Research Site
Wyoming, Michigan, United States
Research Site
Biloxi, Mississippi, United States
Research Site
St Louis, Missouri, United States
Research Site
Omaha, Nebraska, United States
Research Site
Las Vegas, Nevada, United States
Research Site
Trenton, New Jersey, United States
Research Site
Albuquerque, New Mexico, United States
Research Site
Endwell, New York, United States
Research Site
Charlotte, North Carolina, United States
Research Site
Greensboro, North Carolina, United States
Research Site
High Point, North Carolina, United States
Research Site
Winston-Salem, North Carolina, United States
Research Site
Beavercreek, Ohio, United States
Research Site
Edmond, Oklahoma, United States
Research Site
Collegeville, Pennsylvania, United States
Research Site
Levittown, Pennsylvania, United States
Research Site
Greer, South Carolina, United States
Research Site
Chattanooga, Tennessee, United States
Research Site
Kingsport, Tennessee, United States
Research Site
West Jordan, Utah, United States
Countries
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References
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Argoff CE, Brennan MJ, Camilleri M, Davies A, Fudin J, Galluzzi KE, Gudin J, Lembo A, Stanos SP, Webster LR. Consensus Recommendations on Initiating Prescription Therapies for Opioid-Induced Constipation. Pain Med. 2015 Dec;16(12):2324-37. doi: 10.1111/pme.12937. Epub 2015 Nov 19.
Bell TJ, Panchal SJ, Miaskowski C, Bolge SC, Milanova T, Williamson R. The prevalence, severity, and impact of opioid-induced bowel dysfunction: results of a US and European Patient Survey (PROBE 1). Pain Med. 2009 Jan;10(1):35-42. doi: 10.1111/j.1526-4637.2008.00495.x. Epub 2008 Aug 18.
Camilleri M, Drossman DA, Becker G, Webster LR, Davies AN, Mawe GM. Emerging treatments in neurogastroenterology: a multidisciplinary working group consensus statement on opioid-induced constipation. Neurogastroenterol Motil. 2014 Oct;26(10):1386-95. doi: 10.1111/nmo.12417. Epub 2014 Aug 28.
Chey WD, Webster L, Sostek M, Lappalainen J, Barker PN, Tack J. Naloxegol for opioid-induced constipation in patients with noncancer pain. N Engl J Med. 2014 Jun 19;370(25):2387-96. doi: 10.1056/NEJMoa1310246. Epub 2014 Jun 4.
Coyne KS, LoCasale RJ, Datto CJ, Sexton CC, Yeomans K, Tack J. Opioid-induced constipation in patients with chronic noncancer pain in the USA, Canada, Germany, and the UK: descriptive analysis of baseline patient-reported outcomes and retrospective chart review. Clinicoecon Outcomes Res. 2014 May 23;6:269-81. doi: 10.2147/CEOR.S61602. eCollection 2014.
Coyne KS, Margolis MK, Yeomans K, King FR, Chavoshi S, Payne KA, LoCasale RJ. Opioid-Induced Constipation Among Patients with Chronic Noncancer Pain in the United States, Canada, Germany, and the United Kingdom: Laxative Use, Response, and Symptom Burden Over Time. Pain Med. 2015 Aug;16(8):1551-65. doi: 10.1111/pme.12724. Epub 2015 Mar 20.
Hurst H, Bolton J. Assessing the clinical significance of change scores recorded on subjective outcome measures. J Manipulative Physiol Ther. 2004 Jan;27(1):26-35. doi: 10.1016/j.jmpt.2003.11.003.
Holzer P. New approaches to the treatment of opioid-induced constipation. Eur Rev Med Pharmacol Sci. 2008 Aug;12 Suppl 1(0 1):119-27.
Johanson JF. Review of the treatment options for chronic constipation. MedGenMed. 2007 May 2;9(2):25.
Kumar L, Barker C, Emmanuel A. Opioid-induced constipation: pathophysiology, clinical consequences, and management. Gastroenterol Res Pract. 2014;2014:141737. doi: 10.1155/2014/141737. Epub 2014 May 5.
McGraw T. Safety of polyethylene glycol 3350 solution in chronic constipation: randomized, placebo-controlled trial. Clin Exp Gastroenterol. 2016 Jul 15;9:173-80. doi: 10.2147/CEG.S111693. eCollection 2016.
Brenner DM, Hu Y, Datto C, Creanga D, Camilleri M. A Randomized, Multicenter, Prospective, Crossover, Open-Label Study of Factors Associated With Patient Preferences for Naloxegol or PEG 3350 for Opioid-Induced Constipation. Am J Gastroenterol. 2019 Jun;114(6):954-963. doi: 10.14309/ajg.0000000000000229.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Movantik\_D3820L00017\_Protocol\_Original-26Jan17\_Redacted\_PDF-A
Movantik\_D3820L00017\_SAP\_Redacted\_15Aug2017\_PDF-A
Other Identifiers
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D3820L00017
Identifier Type: -
Identifier Source: org_study_id
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