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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 : Recruiting
First Posted : August 20, 2018
Last Update Posted : February 27, 2019
Sponsor:
Collaborator:
Apices Soluciones S.L.
Information provided by (Responsible Party):
Kyowa Kirin Pharmaceutical Development Ltd

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.


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Study Type : Observational
Estimated Enrollment : 315 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
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation
Drug Information available for: Naloxegol


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


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)



Information from the National Library of Medicine

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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


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


Contacts
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Contact: Ana Fernández Velasco, MD +34 607 570 505 ana.fernandez@kyowakirin.com
Contact: Jonathan Chambers +44 (0)7789 378753 jonathan.chambers@kyowakirin.com

Locations
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Denmark
Aalborg University Hospital Not yet recruiting
Aalborg, Denmark
Contact: Klaus Jakobsen         
Finland
Tampere University Hospital Not yet recruiting
Tampere, Finland
Contact: Juho Lehto         
France
Paul Papin à Angers et site René Gauducheau Recruiting
Nantes, France
Contact: Denis Duporioron         
Germany
Lubecker Onkologische Active, not recruiting
Lübeck, Germany
Greece
Areteion Hospital Recruiting
Athens, Greece
Contact: Kyriaki Mystakidou         
Italy
AORN dei Colli Recruiting
Napoli, Italy
Contact: Vincenzo Montesarchio         
Netherlands
Rijnstate hospital Not yet recruiting
Arnhem, Netherlands
Contact: Maurice van der vorst         
Spain
ICO-Hospitalet Recruiting
Barcelona, Spain
Contact: Ricard Mesia         
Sweden
Skane University Hospital Active, not recruiting
Lund, Sweden
United Kingdom
Royal Surrey County Hospital Not yet recruiting
Guildford, Surrey, United Kingdom
Contact: Andrew Davies         
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

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Responsible Party: Kyowa Kirin Pharmaceutical Development Ltd
ClinicalTrials.gov Identifier: NCT03638440     History of Changes
Other Study ID Numbers: NACASY
First Posted: August 20, 2018    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019

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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
Signs and Symptoms, Digestive
Signs and Symptoms
Pain
Neurologic Manifestations
Analgesics, Opioid
Naloxegol
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists