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.

Study Overview
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Brief Summary
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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.

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

Official Title
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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

Conditions
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Cancer Pain

Intervention / Treatment
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* Drug: Oxycodone Hydrochloride
* Drug: Morphine Sulphate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult men and women aged 19 years or more Patients with cancerous pain who are hospitalized or scheduled for hospitalization at Screening and not planned to be discharged during the study Patients with mean moderate to severe pain over the past 7 days at Screening as verbally confirmed (NRS 4 or higher) Subjects who voluntarily signed the Informed Consent Form for the study Subjects who are capable of understanding details of the study and verbal communication on pain intensity Exclusion Criteria: Patients who reached the narcotic analgesic dose corresponding to the followings for cancerous pain treatment immediately prior to Screening (oral morphine dose 195mg/day, oral oxycodone dose 130mg/day, patch fentanyl dose 75μg/hour) Patients with a medical history of hypersensitivity to an ingredient of oxycodone hydrochloride or morphine sulfate or other narcotic analgesics Patients who have contraindications and cautions when study drugs administered.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxycodone Hydrochloride<br>Brand Name: OxyNorm® Generic name: Oxycodone hydrochloride | Drug: Oxycodone Hydrochloride<br>* Oxycodone injection<br>* Other names: Oxynorm;|
| Active Comparator: Morphine Sulphate<br>Brand name: BC Morphine sulfate Generic name: Morphine sulfate | Drug: Morphine Sulphate<br>* Morphine sulphate injection<br>* Other names: BC morphine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Mean Pain Score(NRS) From Baseline(Day 0) to Day 5. | 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. | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Dose of IV(IV Infusion+Bolus Injection) Study Drug Administered During the Treatment Duration | 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) | 5 days | 
| Patient's Overall Satisfaction With Each Continuous Infusion on Day 5 After Randomization | 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). | 5 days | 
| Investigator's Overall Satisfaction With IV Infusion on 5 Days After Randomization | 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). | 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intravenous injection in cancer pain