NCT03638440

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 183 (actual)
• Sponsor: Kyowa Kirin Pharmaceutical Development Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Detailed 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.

Conditions

• Opioid Induced Constipation

Interventions

Type	Name	Description
DRUG	Naloxegol	Naloxegol is a PEGylated derivative of the μ-opioid receptor antagonist naloxone

Timeline

• Start date: 2018-08-16
• Primary completion: 2020-03-05
• Completion: 2020-03-05
• First posted: 2018-08-20
• Last updated: 2024-06-17

Locations

10 sites across 10 countries: Denmark, Finland, France, Germany, Greece, Italy, Netherlands, Spain, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study