An Interventional Study for Patient With Cancer Pain to Evaluate the Efficacy and Safety of OxyNorm® Compared to Morphine Sulfate Through the IV Continuous Infusion. (SWITCH)
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|ClinicalTrials.gov Identifier: NCT02660229|
Recruitment Status : Completed
First Posted : January 21, 2016
Results First Posted : November 19, 2018
Last Update Posted : November 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cancer Pain||Drug: Oxycodone Hydrochloride Drug: Morphine Sulphate||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||A 5-day, Multicentre, Randomized, Open-label, Parallel Group, Active Control Pilot Study to Evaluate the Efficacy and Safety of OxyNorm® (Oxycodone Hydrochloride Injection) in Comparison With Morphine Sulfate Through the IV Continuous Infusion Regimen in Patients With Cancer Pain|
|Study Start Date :||November 2015|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||July 2016|
Experimental: Oxycodone Hydrochloride
Brand Name: OxyNorm® Generic name: Oxycodone hydrochloride
Drug: Oxycodone Hydrochloride
Other Name: Oxynorm
Active Comparator: Morphine Sulphate
Brand name: BC Morphine sulfate Generic name: Morphine sulfate
Drug: Morphine Sulphate
Morphine sulphate injection
Other Name: BC morphine
- Change in the Mean Pain Score(NRS) From Baseline(Day 0) to Day 5. [ Time Frame: 5 days ]
For the pain assessment value for efficacy assessment, Subjects perform pain grading through Numeric rating score(NRS) from 1 to 10 for the mean pain intensity over the past 7 days at Screening, and mean pain intensity over the past 24 hours at Baseline (Day 0), Day 1, Day 2, Day 3, Day 4, Day 5.
Verbal measurement can be conducted by subjects without using visual data. '0' indicates 'no pain', and as the number increases, the pain gets more severe, and '10' indicates the worst pain.
- Total Dose of IV(IV Infusion+Bolus Injection) Study Drug Administered During the Treatment Duration [ Time Frame: 5 days ]
The dose of the study drugs intravenously administered was checked and recorded every day. The information on the dose administered from baseline to each assessment time point was collected based on records on the chart, and in the event of dose change/end of treatment, pertinent date and time, and dose were recorded accurately on the chart.
‡ Total administered dose of the study drugs (mg)= IV infusion (mg/hr) * [(End date - start date) * 24 + (end time - start time)] + bolus injection (mg)
- Patient's Overall Satisfaction With Each Continuous Infusion on Day 5 After Randomization [ Time Frame: 5 days ]The subjects made an assessment of overall treatment satisfaction regarding pain using the PGI-C on a 7-point scale (1: Very much improved, 2: Much improved, 3: Minimally improved, 4: No change, 5: Minimally worse, 6: Much worse, 7: Very much worse) after baseline and at the end of the study (Day 5).
- Investigator's Overall Satisfaction With IV Infusion on 5 Days After Randomization [ Time Frame: 5 days ]The investigators made an assessment using the CGI-C on a 7-point scale (1: Very much improved, 2: Much improved, 3: Minimally improved, 4: No change, 5: Minimally worse, 6: Much worse, 7: Very much worse).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02660229
|Korea, Republic of|
|Seoul St. Mary's Hospital, The Catholic University of Korea|
|Seoul, Korea, Republic of|
|Principal Investigator:||Jinhyong Kang, Dr. Ph.D||Seoul St. Mary's Hospital, The Catholic University of Korea|