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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Opioid Induced Constipation

Intervention / Treatment
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* Drug: Naloxegol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Naloxegol|Naloxegol is a PEGylated derivative of the μ-opioid receptor antagonist naloxone|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety and efficacy of Naloxegol in a real world setting in cancer patients. | Response rate | 4 week treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients that have a BFI score change of ≥12 points at the end of the study treatment | Bowel Function Index (BFI) score change of ≥12 points | 4 week observation period | 
| Proportion of patients that have a BFI score <30 at the end of the study (patients adequately treated). | Bowel Function Index (BFI) score <30 | 4 week observation period | 
| Time to the first post-dose bowel movement | Time to first post-dose bowel movement | 4 week observation period | 
| Change in stool consistency | Bristol stool scale (BSS) | 4 week observation period | 
| Change in Patient Assessment of Constipation (PAC-QOL) | Quality of Life Questionnaire | 4 week observation period | 
| Incidence of overall adverse events, including SAEs | Adverse Events, including SAEs | 4 week observation period | 
| Analgesic treatment interruptions/dose adjustments | Dose adjustments | 4 week observation period | 
| Naloxegol treatment interruptions/dose adjustments | Dose adjustments | 4 week observation period | 
| Patient satisfaction (PGI-I) | Patient Global Impression of Improvement (PGI-I) | 4 week observation period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Opioid Induced Constipation, Naloxegol, Peripherally Acting Mu-Opioids Receptor Antagonist (PAMORA)