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Tolerability, Safety, and Feasibility of Naloxegol in Patients With Cancer and OIC (Opioid Induced Constipation)

NCT02839889 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2019-03-05

Study results available
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Summary

The purpose of this study is to determine if naloxegol can be used in the treatment of opioid-induced constipation in patients with cancer and pain. This phase 4 study consists of a two week randomized double blind period followed by a two week open-label period.

Conditions

Interventions

DRUG

Naloxegol

Naloxegol 25mg tablets for two weeks, followed by a two week open-label period

DRUG

Placebo

Placebo once daily for two weeks, followed by two week open-label period

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Hospice of Henderson County, Inc.

    lead OTHER

Principal Investigators

  • Janet Bull, MD · Hospice of Henderson County, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2018-01-11
Completion
2018-01-11

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT02839889 on ClinicalTrials.gov