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

Opioid Induced Constipation Clinical Trial

— NACASY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03638440
• Other study ID #: NACASY
• Status: Completed
• Start date: August 16, 2018
• Est. completion date: March 5, 2020

Study information

• Verified date: June 2024
• Source: Kyowa Kirin Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: March 5, 2020
• Est. primary completion date: March 5, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Exclusion Criteria:

• Patients with colorectal cancer

Related Conditions & MeSH terms

• Cancer Pain
• Constipation
• Opioid Induced Constipation
• Opioid-Induced Constipation

Intervention

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

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg
Finland	Tampere University Hospital	Tampere
France	Paul Papin à Angers et site René Gauducheau	Nantes
Germany	Lubecker Onkologische	Lübeck
Greece	Areteion Hospital	Athens
Italy	AORN dei Colli	Napoli
Netherlands	Rijnstate hospital	Arnhem
Spain	ICO-Hospitalet	Barcelona
Sweden	Skane University Hospital	Lund
United Kingdom	Royal Surrey County Hospital	Guildford	Surrey

Sponsors (2)

Lead Sponsor	Collaborator
Kyowa Kirin Pharmaceutical Development Ltd	Apices Soluciones S.L.

Countries where clinical trial is conducted

Denmark,  Finland,  France,  Germany,  Greece,  Italy,  Netherlands,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the safety and efficacy of Naloxegol in a real world setting in cancer patients.	Response rate	4 week treatment period
Secondary	Proportion of patients that have a BFI score change of =12 points at the end of the study treatment	Bowel Function Index (BFI) score change of =12 points	4 week observation period
Secondary	Proportion of patients that have a BFI score <30 at the end of the study (patients adequately treated).	Bowel Function Index (BFI) score <30	4 week observation period
Secondary	Time to the first post-dose bowel movement	Time to first post-dose bowel movement	4 week observation period
Secondary	Change in stool consistency	Bristol stool scale (BSS)	4 week observation period
Secondary	Change in Patient Assessment of Constipation (PAC-QOL)	Quality of Life Questionnaire	4 week observation period
Secondary	Incidence of overall adverse events, including SAEs	Adverse Events, including SAEs	4 week observation period
Secondary	Analgesic treatment interruptions/dose adjustments	Dose adjustments	4 week observation period
Secondary	Naloxegol treatment interruptions/dose adjustments	Dose adjustments	4 week observation period
Secondary	Patient satisfaction (PGI-I)	Patient Global Impression of Improvement (PGI-I)	4 week observation period