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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)

Primary Purpose

Cancer Pain

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Oxycodone Hydrochloride
Morphine Sulphate
Sponsored by
Mundipharma Korea Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer Pain focused on measuring Intravenous injection in cancer pain

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Oxycodone Hydrochloride

Morphine Sulphate

Arm Description

Brand Name: OxyNorm® Generic name: Oxycodone hydrochloride

Brand name: BC Morphine sulfate Generic name: Morphine sulfate

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)
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).
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).

Full Information

First Posted
January 18, 2016
Last Updated
April 30, 2018
Sponsor
Mundipharma Korea Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02660229
Brief Title
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.
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mundipharma Korea Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Pain
Keywords
Intravenous injection in cancer pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oxycodone Hydrochloride
Arm Type
Experimental
Arm Description
Brand Name: OxyNorm® Generic name: Oxycodone hydrochloride
Arm Title
Morphine Sulphate
Arm Type
Active Comparator
Arm Description
Brand name: BC Morphine sulfate Generic name: Morphine sulfate
Intervention Type
Drug
Intervention Name(s)
Oxycodone Hydrochloride
Other Intervention Name(s)
Oxynorm
Intervention Description
Oxycodone injection
Intervention Type
Drug
Intervention Name(s)
Morphine Sulphate
Other Intervention Name(s)
BC morphine
Intervention Description
Morphine sulphate injection
Primary Outcome Measure Information:
Title
Change in the Mean Pain Score(NRS) From Baseline(Day 0) to Day 5.
Description
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.
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Total Dose of IV(IV Infusion+Bolus Injection) Study Drug Administered During the Treatment Duration
Description
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)
Time Frame
5 days
Title
Patient's Overall Satisfaction With Each Continuous Infusion on Day 5 After Randomization
Description
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).
Time Frame
5 days
Title
Investigator's Overall Satisfaction With IV Infusion on 5 Days After Randomization
Description
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).
Time Frame
5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinhyong Kang, Dr. Ph.D
Organizational Affiliation
Seoul St. Mary's Hospital, The Catholic University of Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul St. Mary's Hospital, The Catholic University of Korea
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29670416
Citation
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.
Results Reference
derived

Learn more about this trial

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.

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