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.

Cancer Pain Clinical Trial

— SWITCH  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02660229
• Other study ID #: OXI15-KR-401
• Status: Completed
• Phase: Phase 4
• Start date: November 2015
• Est. completion date: July 2016

Study information

• Verified date: April 2018
• Source: Mundipharma Korea Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer Pain

Intervention

Drug:
• Oxycodone Hydrochloride
Oxycodone injection
• Morphine Sulphate
Morphine sulphate injection

Locations

Country	Name	City	State
Korea, Republic of	Seoul St. Mary's Hospital, The Catholic University of Korea	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Mundipharma Korea Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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