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.

Phase 4

Completed

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

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Morphine Sulphate	Morphine Sulphate	Brand name: BC Morphine sulfate Generic name: Morphine sulfate
Oxycodone Hydrochloride	Oxycodone Hydrochloride	Brand Name: OxyNorm® Generic name: Oxycodone hydrochloride

Primary Outcome Measures

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

Secondary Outcome Measures

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