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Report for Clinical Trial NCT03176199

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

An Interventional, Open Label, and Randomized Controlled Study to Compare the Titration Efficacy and Safety of Control-released Oxycodone and Immediate-released Oxycodone in Opioid-naive Patients With Moderate to Severe Cancer Pain

This study is to evaluate the efficacy and safety of a titration method by selects 10 mg control-released (CR) oxycodone tablet as background drug in combined with immediate-released (IR) oxycodone, compared to conventional titration method with immediate-released (IR) oxycodone in patients with moderate to severe cancer pain in Taiwan.

NCT03176199 Cancer Pain
MeSH: Cancer Pain

2 Interventions

Name: Oxycodone

Description: Every 12 hours for control-released oxycodone (OxyContin®)

Type: Drug

Control-released oxycodone

Name: Oxycodone

Description: Every 6 hours for immediate-released oxycodone (OxyNorm®)

Type: Drug

Immediate-released oxycodone


Primary Outcomes

Description: The change from baseline of NRS pain score and the daily number of breakthrough pain

Measure: To evaluate the variable change of NRS pain score and the number of breakthrough pain to obtain pain control after treatment

Time: Up to 14 days

Secondary Outcomes

Description: The percentage of patients in each titration cycle

Measure: To evaluate the percentage of patients in each titration cycle

Time: Up to 14 days

Description: The number of patients who switched/discontinued therapy due to serious adverse events or lack of pain control

Measure: To evaluate the number of patients who switched/discontinued therapy due to serious adverse events or lack of pain control

Time: Up to 14 days

Description: The total opioid taken within 24 hrs daily from baseline to day 14

Measure: The total opioid taken within 24hrs daily from baseline to day 14

Time: Up to 14 days

Description: Mean daily NRS score of patients from baseline to day 14

Measure: To evaluate the mean daily NRS score of subjects from baseline to day 14

Time: Up to 14 days

Description: The total daily rescue dose taken (immediate-released oxycodone capsule) for treatment of breakthrough pain among patients from baseline to day 14

Measure: To evaluate the total daily rescue dose taken (immediate-released oxycodone capsule) for treatment of breakthrough pain among patients from baseline to day 14

Time: Up to 14 days

Description: The occurrence rate of adverse events and physical examination status

Measure: To evaluate the tolerability and safety of Oxycodone CR and IR in cancer pain patient

Time: Up to 28 days

Description: The change from baseline in questionnaire

Measure: To evaluate the change from baseline in questionnaire

Time: Up to 14 days

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 Q12H

Meanwhile, the titration with IR oxycodone will be added according to the pain intensity, e.g. if patient receiving 6 tablets of 10 mg CR oxycodone (giving in Q12H frequency for 3 days), 12 capsules of 5mg IR oxycodone will be dispensed for managing acute pain (rescue use) for the first cycle. --- Q12H ---



HPO Nodes