Spots Global Cancer Trial Database for Real World Observational Study of Naloxegol for Patients With Cancer Pain Diagnosed With OIC.

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Trial Identification

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

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

Study ID: NCT03638440

Conditions

Opioid Induced Constipation

Interventions

Naloxegol

Study Description

Brief 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.