Clinical trial · Observational
Real World Observational Study of Naloxegol for Patients With Cancer Pain Diagnosed With OIC.
Real World Observational Study of Naloxegol for Patients With Cancer Pain Diagnosed With Opioid Induced Constipation.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Opioid Induced Constipation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Naloxegol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To assess the safety and efficacy of Naloxegol in a real world setting in cancer patients.
- timeFrame
- 4 week treatment period
- description
- Response rate
Secondary outcomes (9)
- measure
- Proportion of patients that have a BFI score change of ≥12 points at the end of the study treatment
- timeFrame
- 4 week observation period
- description
- Bowel Function Index (BFI) score change of ≥12 points
- measure
- Proportion of patients that have a BFI score <30 at the end of the study (patients adequately treated).
- timeFrame
- 4 week observation period
- description
- Bowel Function Index (BFI) score \<30
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available