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

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ClinicalTrials.gov Identifier: NCT03638440
Recruitment Status : Completed
First Posted : August 20, 2018
Last Update Posted : May 16, 2022
Sponsor:
Collaborator:
Apices Soluciones S.L.
Information provided by (Responsible Party):
Kyowa Kirin Pharmaceutical Development Ltd

Study Description
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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.

Condition or disease Intervention/treatment
Opioid Induced Constipation 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 Design
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Study Type : Observational
Actual Enrollment : 183 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Real World Observational Study of Naloxegol for Patients With Cancer Pain Diagnosed With Opioid Induced Constipation.
Actual Study Start Date : August 16, 2018
Actual Primary Completion Date : March 5, 2020
Actual Study Completion Date : March 5, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation
Drug Information available for: Naloxegol

Groups and Cohorts
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Intervention Details:
  • Drug: Naloxegol
    Naloxegol is a PEGylated derivative of the μ-opioid receptor antagonist naloxone
    Other Name: Moventig

Outcome Measures
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Primary Outcome Measures :
  1. To assess the safety and efficacy of Naloxegol in a real world setting in cancer patients. [ Time Frame: 4 week treatment period ]
    Response rate


Secondary Outcome Measures :
  1. Proportion of patients that have a BFI score change of ≥12 points at the end of the study treatment [ Time Frame: 4 week observation period ]
    Bowel Function Index (BFI) score change of ≥12 points

  2. Proportion of patients that have a BFI score <30 at the end of the study (patients adequately treated). [ Time Frame: 4 week observation period ]
    Bowel Function Index (BFI) score <30

  3. Time to the first post-dose bowel movement [ Time Frame: 4 week observation period ]
    Time to first post-dose bowel movement

  4. Change in stool consistency [ Time Frame: 4 week observation period ]
    Bristol stool scale (BSS)

  5. Change in Patient Assessment of Constipation (PAC-QOL) [ Time Frame: 4 week observation period ]
    Quality of Life Questionnaire

  6. Incidence of overall adverse events, including SAEs [ Time Frame: 4 week observation period ]
    Adverse Events, including SAEs

  7. Analgesic treatment interruptions/dose adjustments [ Time Frame: 4 week observation period ]
    Dose adjustments

  8. Naloxegol treatment interruptions/dose adjustments [ Time Frame: 4 week observation period ]
    Dose adjustments

  9. Patient satisfaction (PGI-I) [ Time Frame: 4 week observation period ]
    Patient Global Impression of Improvement (PGI-I)


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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.
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03638440


Locations
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Denmark
Aalborg University Hospital
Aalborg, Denmark
Finland
Tampere University Hospital
Tampere, Finland
France
Paul Papin à Angers et site René Gauducheau
Nantes, France
Germany
Lubecker Onkologische
Lübeck, Germany
Greece
Areteion Hospital
Athens, Greece
Italy
AORN dei Colli
Napoli, Italy
Netherlands
Rijnstate hospital
Arnhem, Netherlands
Spain
ICO-Hospitalet
Barcelona, Spain
Sweden
Skane University Hospital
Lund, Sweden
United Kingdom
Royal Surrey County Hospital
Guildford, Surrey, United Kingdom
Sponsors and Collaborators
Kyowa Kirin Pharmaceutical Development Ltd
Apices Soluciones S.L.
Investigators
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Principal Investigator: Andrew Davies, MD Royal Surrey County Hospital NHS Foundation Trust
Principal Investigator: Jan Tack, MD University Hospital KU Leuven
More Information
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Responsible Party: Kyowa Kirin Pharmaceutical Development Ltd
ClinicalTrials.gov Identifier: NCT03638440    
Other Study ID Numbers: NACASY
First Posted: August 20, 2018    Key Record Dates
Last Update Posted: May 16, 2022
Last Verified: May 2022

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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
Keywords provided by Kyowa Kirin Pharmaceutical Development Ltd:
Opioid Induced Constipation
Naloxegol
Peripherally Acting Mu-Opioids Receptor Antagonist (PAMORA)
Additional relevant MeSH terms:
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Constipation
Cancer Pain
Opioid-Induced Constipation
Signs and Symptoms, Digestive
Pain
Neurologic Manifestations
Narcotic-Related Disorders
Substance-Related Disorders
 Chemically-Induced Disorders
Mental Disorders
Naloxegol
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents