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Brand Name: OxyNorm® Generic name: Oxycodone hydrochloride

Brand name: BC Morphine sulfate Generic name: Morphine sulfate

Oxycodone Hydrochloride

Morphine Sulphate

Jinhyong Kang, Dr. Ph.D

The purpose of this study is to compare of difference in NRS scores from baseline to the completion of treatment (5 days) in patients with administration of morphine sulfate versus oxycodone hydrochloride.

5days, Multi-centers, Randomization, Open label, Parallel, Active Comparator, Phase 4 Study.

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.

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

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.

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)

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).

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).

Mundipharma Korea Ltd

The safety analysis was performed regarding AEs, vital signs, physical examination, clinical laboratory test, and ECG in the Safety set involving all subjects who received the study drug after randomization in this clinical study.

Brand Name: OxyNorm® Generic name: Oxycodone hydrochloride

Oxycodone Hydrochloride: Oxycodone injection

Brand name: BC Morphine sulfate Generic name: Morphine sulfate

Morphine Sulphate: Morphine sulphate injection

Brand Name: OxyNorm® Generic name: Oxycodone hydrochloride

Oxycodone Hydrochloride: Oxycodone IV injection

Brand name: BC Morphine sulfate Generic name: Morphine sulfate

Morphine Sulphate: Morphine sulphate IV injection

Total

<39 years

40-49 years

50-59 years

60-69 years

Age, Customized

Sex: Female, Male

Korea, Republic of

Region of Enrollment

Mrs Suyoun Yang/CR head

Change in the Mean Pain Score(NRS) From Baseline(Day 0) to Day 5.

Total Dose of IV(IV Infusion+Bolus Injection) Study Drug Administered During the Treatment Duration

FAS set. However, OxyNorm 1 subject (S08-09) and Morphine sulfate 1 subject (S08-15) were not assessed on Day 5 after baseline. So, missing data was excluded from analysis. Oxynorm group 32 subjects and Morphine group 31 subjects were analysed for PGIC.

Patient's Overall Satisfaction With Each Continuous Infusion on Day 5 After Randomization

FAS set. However, OxyNorm 1 subject (S08-09) and Morphine sulfate 1 subject (S08-15) were not assessed on Day 5 after baseline.

So, the data was missed.

Investigator's Overall Satisfaction With IV Infusion on 5 Days After Randomization

Brand Name: OxyNorm® Generic name: Oxycodone hydrochloride

Oxycodone Hydrochloride: Oxycodone injection. The 10mg/1ml or 20mg/2ml was injected through intravenous PCA according to patient's pain intensity

Brand name: BC Morphine sulfate Generic name: Morphine sulfate

Morphine Sulphate: Morphine sulphate injection. The 5mg/5ml or 30mg/2ml was injected through intravenous PCA according to patient's pain intensity.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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.	NCT02660229	Cancer Pain	Oxycodone Hydro... Morphine Sulpha...	19 Years -	Mundipharma Korea Ltd
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.	NCT02660229	Cancer Pain	Oxycodone Hydro... Morphine Sulpha...	19 Years -	Mundipharma Korea Ltd

Spots Global Cancer Trial Database for intravenous injection in cancer pain