Real World Observational Study of Naloxegol for Patients With Cancer Pain Diagnosed With OIC.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

183 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-16

Study Completion Date

2020-03-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a single-arm, open label, multinational, multicentre, prospective, real world observational study of Naloxegol in adult subjects with Opioid Induced Constipation (OIC) in patients receiving Naloxegol in routine clinical practice. Subjects who are receiving Naloxegol (prescribed by their physician according to the SmPC, which recommends that all currently used maintenance laxative therapy should be halted) during the enrolment period may be eligible for enrolment into the study.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of the Quality of Life of Patients With Opioid-induced Constipation Under Treatment With Naloxegol

NCT04173858

Opioid-induced Constipation

COMPLETED

The Effect of Naloxegol on Refractory Constipation in the Intensive Care Unit

NCT02705378

Constipation Critical Illness

WITHDRAWN PHASE3

Efficacy and Safety of Naldemedine in Treating Opioid-induced Constipation

NCT01993940

Opioid-induced Constipation

COMPLETED PHASE3

Methylnaltrexone for Treatment of Opiate-Induced Constipation in the Intensive Care Unit

NCT01050595

Opioid-induced Constipation

UNKNOWN PHASE3

Phase I Pharmacokinetics and Safety Study of Naloxegol in Paediatric OIC Patients

NCT02099591

Constipation, Signs and Symptoms, Digestive

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The objective of this study is to assess the safety and efficacy of Naloxegol in a real world setting in cancer patients.

The primary safety end point is the incidence of adverse events leading to study discontinuation.

The primary efficacy end point is the response rate assessed in the 4 week observation period. Response is defined as three or more bowel movements (without the use of rescue laxative treatment in the previous 24 hours) per week and an increase of one or more bowel movements over baseline.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Opioid Induced Constipation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Naloxegol

Naloxegol is a PEGylated derivative of the μ-opioid receptor antagonist naloxone

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Moventig

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patient ≥ 18 years old
* Patient who is receiving treatment with opioids for at least 4 weeks, and is expected to remain on opioids for duration of study
* Patient with opioid-induced constipation
* Patient in whom the clinician plans treatment with Naloxegol according to routine clinical practice (Naloxegol SmPC recommends that all currently used maintenance laxative therapy should be halted)
* Signing of the informed consent