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

NCT03638440 | Completed FDA Drug

• 1 other identifier: NACASY
• Study Type: observational
• Target: 183
• Locations: 10 countries
• Sites: 10

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.

Conditions

Opioid Induced Constipation

Keywords

Opioid Induced Constipation; Naloxegol; Peripherally Acting Mu-Opioids Receptor Antagonist (PAMORA)

Outcome Measures

Primary Outcomes (1)

• To assess the safety and efficacy of Naloxegol in a real world setting in cancer patients.

  Response rate

  4 week treatment period

Secondary Outcomes (9)

• Proportion of patients that have a BFI score change of ≥12 points at the end of the study treatment

  4 week observation period

• Proportion of patients that have a BFI score <30 at the end of the study (patients adequately treated).

  4 week observation period

• Time to the first post-dose bowel movement

  4 week observation period

• Change in stool consistency

  4 week observation period

• Change in Patient Assessment of Constipation (PAC-QOL)

  4 week observation period

Interventions

Naloxegol DRUG

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

Also known as: Moventig

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• \- Patients with colorectal cancer

Sponsors & Collaborators

• Kyowa Kirin Pharmaceutical Development Ltd: lead
• Apices Soluciones S.L.: collaborator

Study Sites (10)

Aalborg University Hospital

Aalborg, Denmark

Location

Tampere University Hospital

Tampere, Finland

Location

Paul Papin à Angers et site René Gauducheau

Nantes, France

Location

Lubecker Onkologische

Lübeck, Germany

Location

Areteion Hospital

Athens, Greece

Location

AORN dei Colli

Napoli, Italy

Location

Rijnstate hospital

Arnhem, Netherlands

Location

ICO-Hospitalet

Barcelona, Spain

Location

Skane University Hospital

Lund, Sweden

Location

Royal Surrey County Hospital

Guildford, Surrey, United Kingdom

Location

MeSH Terms

Conditions

Opioid-Induced Constipation

Interventions

naloxegol

Condition Hierarchy (Ancestors)

Constipation; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Andrew Davies, MD

  Royal Surrey County Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

• Jan Tack, MD

  University Hospital KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2018
• First Posted: August 20, 2018
• Study Start: August 16, 2018
• Primary Completion: March 5, 2020
• Study Completion: March 5, 2020
• Last Updated: June 17, 2024

Record last verified: 2024-06

Locations

FI (1); NL (1); IT (1); FR (1); SE (1); DE (1); ES (1); DK (1); GR (1); GB (1)