Clinical trial · Interventional
A Study to Assess the Safety and Tolerability of Oxycodone Hydrochloride 50mg/mL Administered as an Infusion
An Open, Multi-centre, Non-comparative Observational Study to Assess the Safety and Tolerability of Oxycodone Injection 50 mg/mL as a Subcutaneous Infusion in Patients With Severe Cancer Pain.
NCT00626600CI-TRIAL-00035441terminatedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of recruitment
Summary
Brief summary (as posted)
Assessing the safety and tolerability of Oxycodone Hydrochloride 50mg/mL in subjects with severe cancer pain.
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 |
|---|---|---|---|
| Severe Caner Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oxycodone Hydrochloride | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To assess the safety and tolerability of Oxycodone hydrochloride injection 50 mg/mL
- timeFrame
- 20 Days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria 1. Male or female subjects aged 18 years and above, who have severe cancer pain. 2. Subjects who require a strong opioid by subcutaneous infusion to stabilise and manage their cancer pain effectively. 3. Subjects who give written informed consent to participate in the study. 4. Subjects who agree to their primary care physician being informed of their participation in the study. 5. Subjects who consent to processing of their trial data according to the requirements of the UK Data Protection Act 1998. Exclusion Criteria 1. Subjects who are pregnant, lactating or in the Investigators opinion are at risk of conceiving and are not using adequate contraception measures. 2. Subjects with known hypersensitivity (allergic reaction) to oxycodone, any other opioids or any of the excipients. 3. Subjects who are planned to receive chemotherapy during the study treatment period or are currently receiving continuous i.v. chemotherapy infusion. 4. Subjects with neutropenia, thrombocytopenia or coagulation disorders. 5. Subjects with any contraindications to oxycodone as outlined in the Investigator Brochure or Summary Product Information sheet for oxycodone. 6. Subjects who are currently participating in another clinical research study involving a new chemical entity. 7. Subjects whom the Investigator believes to be medically unfit to receive the study medication, or unsuitable for any other reason.
References
Publications (0)
Data not yet available
No reference posted for this study.