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.

• Status: Completed
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mundipharma Korea Ltd
• Treatments: Morphine; Oxycodone

Criteria

Inclusion Criteria:

1. Adult men and women aged 19 years or more

2. Patients with cancerous pain who are hospitalized or scheduled for hospitalization at Screening and not planned to be discharged during the study

3. Patients with mean moderate to severe pain over the past 7 days at Screening as verbally confirmed (NRS 4 or higher)

4. Subjects who voluntarily signed the Informed Consent Form for the study

5. Subjects who are capable of understanding details of the study and verbal communication on pain intensity

Exclusion Criteria:

1. 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)

2. Patients with a medical history of hypersensitivity to an ingredient of oxycodone hydrochloride or morphine sulfate or other narcotic analgesics

3. Patients who have contraindications and cautions when study drugs administered.