To evaluate patient preference of Movantik and Polyethylene Glycol 3350 for opioid induced constipation
Study identifier:D3820L00017
ClinicalTrials.gov identifier:NCT03060512
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase IV, Randomized, Multi-Center, Open-Label, Prospective, Crossover Study to Evaluate Patient Preference of Movantik™ versus Polyethylene Glycol 3350 for Opioid-Induced Constipation (OIC) Treatment
Medical condition
Opioid induced constipation
Phase
Phase 4
Healthy volunteers
No
Study drug
Polyethylene Glycol 3350, Movantik
Sex
All
Actual Enrollment
276
Study type
Interventional
Age
18 Years - 84 Years
Date
Study Start Date: 02 Mar 2017
Primary Completion Date: 23 Aug 2017
Study Completion Date: 23 Aug 2017
Study design
Allocation: Randomized
Endpoint Classification: Efficacy
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Jul 2018 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
QuintilesIMS, Inc.
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 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. | Drug: 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. Other Name: MiraLAX Drug: 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 Name: Naloxegol |
| Active Comparator: 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. | Drug: 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. Other Name: MiraLAX Drug: 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 Name: Naloxegol |
Contacts
Investigators
Principal Investigator
AstraZeneca Scientific Leadership
AstraZeneca
