CancerPhase 3NCT02084355
Study of Opioid Rotation Versus Opioid Escalation in Patients With Moderate to Severe Cancer Pain
A Phase 3 study testing oral oxycodone, oral hydromorphone and fentanyl patch in people with Cancer and Pain, run by Gyeongsang National University Hospital at 1 site in South Korea.
Trial summary
Although opioid rotation is well known treatment modality in reducing pain and opioid-induced neurotoxicity, it is not established whether opioid rotation is more appropriate or opioid escalation is more effective in controlling significant pain in cancer patients under opioid medication. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- oral oxycodone, oral hydromorphone and fentanyl patch
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2014to Jan 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 18 years
- patients who are being treated with one of strong opioids including oral oxycodone, oral hydromorphone, or fentanyl patch with range from 60 mg to 200 mg of oral morphine equivalent daily dose (MEDD)
- moderate to severe cancer pain (numeric rating scale more than 3) at screening
- patients without uncontrolled adverse effects associated with currently applied opioid
Who cannot join
- previous opioid rotation
- unable to take oral medication
- life expectancy less than a month
- newly started chemotherapy and/or radiotherapy within past 2 weeks of screening
- serum aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatase > 2.5 times of upper normal limit
- serum total bilirubin or creatinine > 1.5 times of upper normal limit
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Gyeongsang National University Hospital
Jinju, Gyeongsangnam-do, 660-702
Se-Il Go, M.D., +82 55 750 9454 ext. 9454, gose1@hanmail.net
About this study
Official title: Efficacy and Safety of Opioid Rotation Compared With Opioid Dose Escalation in Patients With Moderate to Severe Cancer Pain - Open Label, Randomized, Prospective Study
Although opioid rotation is well known treatment modality in reducing pain and opioid-induced neurotoxicity, it is not established whether opioid rotation is more appropriate or opioid escalation is more effective in controlling significant pain in cancer patients under opioid medication.
- The purpose of this study is to determine effective therapy out of opioid rotation and opioid dose escalation in patients with moderate to severe cancer pain who have been already treated with strong opioid.
- Being tested
- oral oxycodone, oral hydromorphone, fentanyl patch
- Keywords
- Significant cancer pain, at least numeric rating scale 4
- Medical subject headings
- Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral oxycodoneDrug
oral hydromorphoneDrug
fentanyl patchDrug
| Study group | Role | What they receive |
|---|---|---|
| opioid rotation | Experimental | Patients who are randomized to opioid rotation are treated with strong opioid other than currently used strong opioid (Reduce the dose by 25%-50% to allow for incomplete cross-tolerance between different opioids).
* oral oxycodone : convert to oral hydromorphone or fentanyl patch
* oral hydromorphone : convert to oral oxycodone or fentanyl patch
* fentanyl patch : convert to oral oxycodone or oral hydromorphone Receives: Drug: oral oxycodone; Drug: oral hydromorphone; Drug: fentanyl patch |
| opioid dose escalation | Active comparator | Patients who are randomized to opioid dose escalation will be treated cancer pain by escalation dose of same strong opioid.
* oral oxycodone : maintain oral oxycodone and titrate the dose
* oral hydromorphone : maintain oral hydromorphone and titrate the dose
* fentanyl patch : maintain fentanyl patch and titrate the dose Receives: Drug: oral oxycodone; Drug: oral hydromorphone; Drug: fentanyl patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of successful pain control defined as a 30% or 2-point reduction in the numeric rating scale
Measured: Eighteen months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2015 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gyeongsang National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jung Hun Kang, Gyeongsang National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02084355
- Sponsor's protocol ID
- GNUH-2013-07-014
- Status last verified
- Mar 2014
- First submitted
- 5 Mar 2014
- Last updated
- 12 Mar 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Opioid Rotation Compared With Opioid Dose Escalation in Patients With Moderate to Severe Cancer Pain - Open Label, Randomized, Prospective Study
- ClinicalTrials.gov ID
- NCT02084355
- Acronym / sponsor ID
- GNUH-2013-07-014
- Keywords
- Significant cancer pain, at least numeric rating scale 4
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Gyeongsang National University HospitalUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 12 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Although opioid rotation is well known treatment modality in reducing pain and opioid-induced neurotoxicity, it is not established whether opioid rotation is more appropriate or opioid escalation is more effective in controlling significant pain in cancer patients under opioid medication.
- The purpose of this study is to determine effective therapy out of opioid rotation and opioid dose escalation in patients with moderate to severe cancer pain who have been already treated with strong opioid.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| opioid rotation | Experimental | Drug: oral oxycodone, Drug: oral hydromorphone, Drug: fentanyl patchPatients who are randomized to opioid rotation are treated with strong opioid other than currently used strong opioid (Reduce the dose by 25%-50% to allow for incomplete cross-tolerance between different opioids). * oral oxycodone : convert to oral hydromorphone or fentanyl patch * oral hydromorphone : convert to oral oxycodone or fentanyl patch * fentanyl patch : convert to oral oxycodone or oral hydromorphone |
| opioid dose escalation | Active comparator | Drug: oral oxycodone, Drug: oral hydromorphone, Drug: fentanyl patchPatients who are randomized to opioid dose escalation will be treated cancer pain by escalation dose of same strong opioid. * oral oxycodone : maintain oral oxycodone and titrate the dose * oral hydromorphone : maintain oral hydromorphone and titrate the dose * fentanyl patch : maintain fentanyl patch and titrate the dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age > 18 years
- patients who are being treated with one of strong opioids including oral oxycodone, oral hydromorphone, or fentanyl patch with range from 60 mg to 200 mg of oral morphine equivalent daily dose (MEDD)
- moderate to severe cancer pain (numeric rating scale more than 3) at screening
- patients without uncontrolled adverse effects associated with currently applied opioid
Key exclusion criteria (6 listed)
- previous opioid rotation
- unable to take oral medication
- life expectancy less than a month
- newly started chemotherapy and/or radiotherapy within past 2 weeks of screening
- serum aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatase > 2.5 times of upper normal limit
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 |
|---|---|---|
| oral oxycodone | Drug | opioid dose escalation, opioid rotation |
| oral hydromorphone | Drug | opioid dose escalation, opioid rotation |
| fentanyl patch | Drug | opioid dose escalation, opioid rotation |
Primary outcome
The rate of successful pain control defined as a 30% or 2-point reduction in the numeric rating scale
Time frame: Eighteen months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2014.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing oral oxycodone, oral hydromorphone and fentanyl patch in people with Cancer and Pain, run by Gyeongsang National University Hospital 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 12 Mar 2014. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Se-Il Go, M.D. (+82 55 750 9454 ext. 9454, gose1@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of successful pain control defined as a 30% or 2-point reduction in the numeric rating scale (time frame: Eighteen months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2014; AzTrials last refreshed its copy on 7 Nov 2026.