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A Study to Assess the Safety and Tolerability of Oxycodone Hydrochloride 50mg/mL Administered as an Infusion

2014-08-27 03:32:32 | BioPortfolio

Summary

Assessing the safety and tolerability of Oxycodone Hydrochloride 50mg/mL in subjects with severe cancer pain.

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Severe Caner Pain

Intervention

Oxycodone Hydrochloride

Location

Royal Marsden Hospital
London
United Kingdom
SW3 6JJ

Status

Terminated

Source

Mundipharma Research Limited

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:32:32-0400

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