A Study to Assess the Safety and Tolerability of Oxycodone Hydrochloride 50mg/mL Administered as an Infusion
Phase 3
Terminated
- Conditions
- Severe Caner Pain
- Registration Number
- NCT00626600
- Lead Sponsor
- Mundipharma Research Limited
- Brief Summary
Assessing the safety and tolerability of Oxycodone Hydrochloride 50mg/mL in subjects with severe cancer pain.
- Detailed Description
This is study involving a treatment phase of up to 20 days. During this time patients will receive Oxycodone Hydrochloride 50mg/ml as a subcutaneous infusion. During the treatment phase, safety will be assessed by documentation of type and frequency of spontaneously reported adverse events and adverse events noted after assessment of the infusion site (every 24 hours and when resited). The subjects will be followed up for 7 days to collect information on ongoing AEs/SAEs and any new AEs/SAEs that may have occurred.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 33
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To assess the safety and tolerability of Oxycodone hydrochloride injection 50 mg/mL 20 Days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Royal Marsden Hospital
🇬🇧London, United Kingdom