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

Opioid Induced Constipation Clinical Trial

Official title:
Real World Observational Study of Naloxegol for Patients With Cancer Pain Diagnosed With Opioid Induced Constipation.

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03638440
Study type Observational
Source Kyowa Kirin Co., Ltd.
Contact
Status Completed
Phase
Start date August 16, 2018
Completion date March 5, 2020
View Details
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