CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 276 enrolled
Drug / intervention
Polyethylene Glycol 3350 +1 moredrug
Likely dose
Polyethylene Glycol 3350 5mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03060512
NCT03060512Phase 4Completed
CompareCT.gov

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

AstraZeneca·interventional·Posted Feb 23, 2017·Updated Jul 13, 2018

In Brief

A Phase 4 clinical trial evaluating Polyethylene Glycol 3350 and Movantik for Opioid Induced Constipation. Completed, enrolled 276 participants across 53 sites.

Detailed Summary

The purpose of this study is to determine whether patients with opioid induced constipation prefer treatment with naloxegol (Movantik) or with Polyethylene Glycol 3350.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid Induced Constipation
CountriesUnited States
CollaboratorsQuintilesIMS, Inc.

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 23, 2017
Enrollment StartMar 2, 2017
Primary CompletionAug 23, 2017
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 9.4 years ago

Interventions

Polyethylene Glycol 3350drug

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.

Movantikdrug

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.