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. (SWITCH)

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

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.

Study Overview

• Status: Completed
• Conditions: Cancer Pain
• Intervention / Treatment: Drug: Oxycodone Hydrochloride; Drug: Morphine Sulphate

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul St. Mary's Hospital, The Catholic University of Korea

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Oxycodone Hydrochloride; Brand Name: OxyNorm® Generic name: Oxycodone hydrochloride	Drug: Oxycodone Hydrochloride; Oxycodone injection; Other Names: Oxynorm
ACTIVE_COMPARATOR: Morphine Sulphate; Brand name: BC Morphine sulfate Generic name: Morphine sulfate	Drug: Morphine Sulphate; Morphine sulphate injection; Other Names: BC morphine

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mundipharma Korea Ltd
• Investigators: Principal Investigator: Jinhyong Kang, Dr. Ph.D, Seoul St. Mary's Hospital, The Catholic University of Korea

Publications and helpful links

General Publications

• Lee KH, Kang JH, Oh HS, Choi MK, Shim BY, Eum YJ, Park HJ, Kang JH. Intravenous Oxycodone versus Intravenous Morphine in Cancer Pain: A Randomized, Open-Label, Parallel-Group, Active-Control Study. Pain Res Manag. 2017;2017:9741729. doi: 10.1155/2017/9741729. Epub 2017 Oct 31.

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (ACTUAL): July 1, 2016
• Study Completion (ACTUAL): July 1, 2016

Study Registration Dates

• First Submitted: January 18, 2016
• First Submitted That Met QC Criteria: January 20, 2016
• First Posted (ESTIMATE): January 21, 2016

Study Record Updates

• Last Update Posted (ACTUAL): November 19, 2018
• Last Update Submitted That Met QC Criteria: April 30, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Intravenous injection in cancer pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Cancer Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine; Oxycodone
• Other Study ID Numbers: OXI15-KR-401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO