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

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

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.

Study Overview

• Status: Completed
• Conditions: Opioid Induced Constipation
• Intervention / Treatment: Drug: Naloxegol

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.

• Study Type: Observational
• Enrollment (Actual): 183

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark
    • Aalborg University Hospital
• Finland
  • Tampere, Finland
    • Tampere University Hospital
• France
  • Nantes, France
    • Paul Papin à Angers et site René Gauducheau
• Germany
  • Lübeck, Germany
    • Lubecker Onkologische
• Greece
  • Athens, Greece
    • Areteion Hospital
• Italy
  • Napoli, Italy
    • Aorn Dei Colli
• Netherlands
  • Arnhem, Netherlands
    • Rijnstate Hospital
• Spain
  • Barcelona, Spain
    • ICO-Hospitalet
• Sweden
  • Lund, Sweden
    • Skåne University Hospital
• United Kingdom
  • Surrey
    • Guildford, Surrey, United Kingdom
      • Royal Surrey County Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

This study will involve 315 patients (out-patients or in-patients) with Opioid Induced Constipation (OIC) from 32 European hospitals.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the safety and efficacy of Naloxegol in a real world setting in cancer patients.	Response rate	4 week treatment period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Time to the first post-dose bowel movement	Time to first post-dose bowel movement	4 week observation period
Change in stool consistency	Bristol stool scale (BSS)	4 week observation period
Change in Patient Assessment of Constipation (PAC-QOL)	Quality of Life Questionnaire	4 week observation period
Incidence of overall adverse events, including SAEs	Adverse Events, including SAEs	4 week observation period
Analgesic treatment interruptions/dose adjustments	Dose adjustments	4 week observation period
Naloxegol treatment interruptions/dose adjustments	Dose adjustments	4 week observation period
Patient satisfaction (PGI-I)	Patient Global Impression of Improvement (PGI-I)	4 week observation period

Collaborators and Investigators

• Sponsor: Kyowa Kirin Pharmaceutical Development Ltd
• Collaborators: Apices Soluciones S.L.
• Investigators: Principal Investigator: Jan Tack, MD, University Hospital KU Leuven

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 16, 2018
• Primary Completion (ACTUAL): March 5, 2020
• Study Completion (ACTUAL): March 5, 2020

Study Registration Dates

• First Submitted: August 7, 2018
• First Submitted That Met QC Criteria: August 16, 2018
• First Posted (ACTUAL): August 20, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 16, 2022
• Last Update Submitted That Met QC Criteria: May 13, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Naloxegol; Opioid Induced Constipation; Peripherally Acting Mu-Opioids Receptor Antagonist (PAMORA)
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Narcotic-Related Disorders; Constipation; Opioid-Induced Constipation; Cancer Pain; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Narcotic Antagonists; Naloxegol
• Other Study ID Numbers: NACASY

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No