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Completed

NCT Number: NCT03638440

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aalborg University Hospital, Aalborg, Denmark

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Naloxegol

Drug

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

Other names: Moventig

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Kyowa Kirin Pharmaceutical Development Ltd

Industry

Collaborators

  • Apices Soluciones S.L.

Registry information

Official study title

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

Acronym: NACASY

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 20, 2018
Registry last updated
Jun 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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