Opioid Induced Constipation
Conditions
Keywords
Opioid Induced Constipation, Naloxegol, Peripherally Acting Mu-Opioids Receptor Antagonist (PAMORA)
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.
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.
Interventions
DRUGNaloxegol
Naloxegol is a PEGylated derivative of the μ-opioid receptor antagonist naloxone
Sponsors
Apices Soluciones S.L.
Kyowa Kirin Pharmaceutical Development Ltd
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the safety and efficacy of Naloxegol in a real world setting in cancer patients. | 4 week treatment period | Response rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction (PGI-I) | 4 week observation period | Patient Global Impression of Improvement (PGI-I) |
| Proportion of patients that have a BFI score change of ≥12 points at the end of the study treatment | 4 week observation period | Bowel Function Index (BFI) score change of ≥12 points |
| Proportion of patients that have a BFI score <30 at the end of the study (patients adequately treated). | 4 week observation period | Bowel Function Index (BFI) score \<30 |
| Time to the first post-dose bowel movement | 4 week observation period | Time to first post-dose bowel movement |
| Naloxegol treatment interruptions/dose adjustments | 4 week observation period | Dose adjustments |
| Change in Patient Assessment of Constipation (PAC-QOL) | 4 week observation period | Quality of Life Questionnaire |
| Incidence of overall adverse events, including SAEs | 4 week observation period | Adverse Events, including SAEs |
| Analgesic treatment interruptions/dose adjustments | 4 week observation period | Dose adjustments |
| Change in stool consistency | 4 week observation period | Bristol stool scale (BSS) |
Countries
Denmark, Finland, France, Germany, Greece, Italy, Netherlands, Spain, Sweden, United Kingdom
Outcome results
None listed