Naloxegol
DrugNaloxegol is a PEGylated derivative of the μ-opioid receptor antagonist naloxone
Other names: Moventig
NCT Number: NCT03638440
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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Notify Me18 year and older
All sexes
Observational
Aalborg University Hospital, Aalborg, Denmark
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Naloxegol is a PEGylated derivative of the μ-opioid receptor antagonist naloxone
Other names: Moventig
Time frame: 4 week treatment period
Response rate
Time frame: 4 week observation period
Bowel Function Index (BFI) score change of ≥12 points
Time frame: 4 week observation period
Bowel Function Index (BFI) score <30
Time frame: 4 week observation period
Time to first post-dose bowel movement
Time frame: 4 week observation period
Bristol stool scale (BSS)
Time frame: 4 week observation period
Quality of Life Questionnaire
Time frame: 4 week observation period
Adverse Events, including SAEs
Time frame: 4 week observation period
Dose adjustments
Time frame: 4 week observation period
Dose adjustments
Time frame: 4 week observation period
Patient Global Impression of Improvement (PGI-I)
Kyowa Kirin Pharmaceutical Development Ltd
Industry
Real World Observational Study of Naloxegol for Patients With Cancer Pain Diagnosed With Opioid Induced Constipation.
Acronym: NACASY
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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