Clinical trial NCT03638440: 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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Opioid Induced Constipation
Keywords: Opioid Induced Constipation
Naloxegol
Peripherally Acting Mu-Opioids Receptor Antagonist (PAMORA)
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Apices Soluciones S.L.
First posted: 2018-08-20
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: To assess the safety and efficacy of Naloxegol in a real world setting in cancer patients.
timeFrame: 4 week treatment period
Secondary outcomes:
measure: Proportion of patients that have a BFI score change of ≥12 points at the end of the study treatment
timeFrame: 4 week observation period
measure: Proportion of patients that have a BFI score <30 at the end of the study (patients adequately treated).
timeFrame: 4 week observation period
measure: Time to the first post-dose bowel movement
timeFrame: 4 week observation period
measure: Change in stool consistency
timeFrame: 4 week observation period
measure: Change in Patient Assessment of Constipation (PAC-QOL)
timeFrame: 4 week observation period
measure: Incidence of overall adverse events, including SAEs
timeFrame: 4 week observation period
measure: Analgesic treatment interruptions/dose adjustments
timeFrame: 4 week observation period
measure: Naloxegol treatment interruptions/dose adjustments
timeFrame: 4 week observation period
measure: Patient satisfaction (PGI-I)
timeFrame: 4 week observation period
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Nantes
country: France
facility: Paul Papin à Angers et site René Gauducheau
city: Lübeck
country: Germany
facility: Lubecker Onkologische
city: Athens
country: Greece
facility: Areteion Hospital
city: Napoli
country: Italy
facility: AORN dei Colli
city: Arnhem
country: Netherlands
facility: Rijnstate hospital
city: Barcelona
country: Spain
facility: ICO-Hospitalet
city: Lund
country: Sweden
facility: Skane University Hospital
city: Guildford
country: United Kingdom
facility: Royal Surrey County Hospital
state: Surrey
Study officials:
affiliation: Royal Surrey County Hospital NHS Foundation Trust
name: Andrew Davies, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital KU Leuven
name: Jan Tack, MD
role: PRINCIPAL_INVESTIGATOR
References: