Cancer PainPhase 4SWITCHNCT02660229

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.

A Phase 4 study testing Oxycodone Hydrochloride and Morphine Sulphate in people with Cancer Pain, run by Mundipharma Korea Ltd at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 19 years and older
Conditions the study is for: Cancer Pain
What is being tested?: Oxycodone Hydrochloride and Morphine Sulphate
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 66 participants
Where: 1 siteSouth Korea
Study dates: Nov 2015to Jul 2016
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

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

Other trials in South Korea

About this study

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

Read the detailed description

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

Conditions: Cancer Pain
Being tested: Oxycodone Hydrochloride, Morphine Sulphate
Keywords: Intravenous injection in cancer pain
Medical subject headings: Cancer Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Oxycodone HydrochlorideDrug
Also called Oxynorm
Oxycodone injection
Morphine SulphateDrug
Also called BC morphine
Morphine sulphate injection

Study groups in NCT02660229
Study group	Role	What they receive
Oxycodone Hydrochloride	Experimental	Brand Name: OxyNorm® Generic name: Oxycodone hydrochloride Receives: Drug: Oxycodone Hydrochloride
Morphine Sulphate	Active comparator	Brand name: BC Morphine sulfate Generic name: Morphine sulfate Receives: Drug: Morphine Sulphate

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 5 days

Secondary outcomes (3)

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)
Measured: 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).
Measured: 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).
Measured: 5 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2015Jul 2016

First posted21 Jan 2016 (estimated)
Study startNov 2015
Primary completionJul 2016
Study completionJul 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Cancer PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02660229
Sponsor's protocol ID: OXI15-KR-401
Acronym: SWITCH
Status last verified: Apr 2018
First submitted: 18 Jan 2016
Last updated: 19 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

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.
PubMed 29670416

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cancer Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02660229
Acronym / sponsor ID: SWITCH / OXI15-KR-401
Conditions: Cancer Pain
Keywords: Intravenous injection in cancer pain
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: Mundipharma Korea LtdIndustry (pharma, biotech, devices)
Study start: Nov 2015
Primary completion: Jul 2016 (actual)
Study completion: Jul 2016 (actual)
First posted: 21 Jan 2016 (estimated)
Results: Posted 19 Nov 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Oxycodone Hydrochloride	Experimental	Drug: Oxycodone HydrochlorideBrand Name: OxyNorm® Generic name: Oxycodone hydrochloride
Morphine Sulphate	Active comparator	Drug: Morphine SulphateBrand name: BC Morphine sulfate Generic name: Morphine sulfate

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Oxycodone HydrochlorideAlso: OxynormOxycodone injection	Drug	Oxycodone Hydrochloride
Morphine SulphateAlso: BC morphineMorphine sulphate injection	Drug	Morphine Sulphate

Primary outcome

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

3 secondary outcomes

Total Dose of IV(IV Infusion+Bolus Injection) Study Drug Administered During the Treatment Duration
Time frame: 5 days
Patient's Overall Satisfaction With Each Continuous Infusion on Day 5 After Randomization
Time frame: 5 days
Investigator's Overall Satisfaction With IV Infusion on 5 Days After Randomization
Time frame: 5 days

Results and safety

Results posted to the registry on 19 Nov 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Oxycodone Hydrochloride	34	32
Morphine Sulphate	32	31

Primary outcome: Change in the Mean Pain Score(NRS) From Baseline(Day 0) to Day 5.

Time frame: 5 days. Mean (Standard Deviation). Unit: units on a scale

Measure	Oxycodone Hydrochloride n = 33	Morphine Sulphate n = 32
Value	-3.52 (2.17)	-3.13 (1.84)

Population analysed: Primary endpoint was analysed FAS set.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 5 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Oxycodone Hydrochloride	3 of 34 (8.8%)	14 of 34 (41.2%)	0 of 34
Morphine Sulphate	2 of 32 (6.3%)	11 of 32 (34.4%)	0 of 32

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29670416Lee 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.
Individual participant dataSharing planned: No

Related trials for Cancer Pain

Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
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Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
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Recruiting
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Active, not recruitingPhase 3
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jinhyong Kang, Dr. Ph.D principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Oxycodone Hydrochloride and Morphine Sulphate in people with Cancer Pain, run by Mundipharma Korea Ltd at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the Mean Pain Score(NRS) From Baseline(Day 0) to Day 5. (time frame: 5 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02660229, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2018.