MedTrace Logo

To Evaluate Patient Preference of Movantik and Polyethylene Glycol 3350 for Opioid Induced Constipation

NCT03060512 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 276

Last updated 2018-07-13

Study results available
· View outcomes & findings →

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.

Conditions

  • Opioid Induced Constipation

Interventions

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.

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.

Sponsors & Collaborators

  • QuintilesIMS, Inc.

    collaborator UNKNOWN

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • AstraZeneca Scientific Leadership · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
84 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-02
Primary Completion
2017-08-23
Completion
2017-08-23
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03060512 on ClinicalTrials.gov