Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Apices Soluciones S.L. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naloxegol | Drug | Naloxegol is a PEGylated derivative of the μ-opioid receptor antagonist naloxone |
|
| 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 |
| 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). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
- Patients with colorectal cancer
Not provided
Not provided
Not provided
Not provided
This study will involve 315 patients (out-patients or in-patients) with Opioid Induced Constipation (OIC) from 32 European hospitals.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Andrew Davies, MD | Royal Surrey County Hospital NHS Foundation Trust | Principal Investigator |
| Jan Tack, MD | University Hospital KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University Hospital | Aalborg | Denmark | ||||
| Tampere University Hospital |
Not provided
| ID | Term |
|---|---|
| D000079689 | Opioid-Induced Constipation |
| ID | Term |
|---|---|
| D003248 | Constipation |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000589308 | naloxegol |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| Tampere |
| Finland |
| Paul Papin à Angers et site René Gauducheau | Nantes | France |
| Lubecker Onkologische | Lübeck | Germany |
| Areteion Hospital | Athens | Greece |
| AORN dei Colli | Naples | Italy |
| Rijnstate hospital | Arnhem | Netherlands |
| ICO-Hospitalet | Barcelona | Spain |
| Skane University Hospital | Lund | Sweden |
| Royal Surrey County Hospital | Guildford | Surrey | United Kingdom |
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |