Opioid, Moderate Cancer Pain, Transdermal Fentanyl, 12.5ug/h, Opioid-naivePhase 3NCT04533243
Opioid Titration With 12.5 ug/h Fentanyl Transdermal Patch vs Orally Morphine for Opioid-naïve Patients With Moderate Cancer Pain
A Phase 3 study testing 2.5ug/h transdermal fentanyl and Oral immediate-released morphine in people with Opioid, Moderate Cancer Pain, Transdermal Fentanyl, 12.5ug/h, Opioid-naive, run by Fujian Cancer Hospital.
Trial summary
Opioid is recommended for moderate cancer pain in WHO 3-step analgesic ladder. Transdermal administration of the strong opioid fentanyl was originally developed for patients unable to swallow analgesics because of malignancies in the head and neck region or the gastrointestinal tract, painful lesions in the mouth, or… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Opioid, Moderate Cancer Pain, Transdermal Fentanyl, 12.5ug/h, Opioid-naive
- What is being tested?
- 2.5ug/h transdermal fentanyl and Oral immediate-released morphine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 209 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2020to 31 Aug 2022
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years old or more;
- ECOG PS ≤3 ;
- Opioid tolerance not moderate pain patients (4≤ NRS ≤6 on 11 points, 0 no pain, 10 most pain);
- No taking strong opioids for the last 30 days;
- Estimated life expectancy of at least 3 months;
- Ability to communicate effectively with the study personnel about the nature of their pain;
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- Ability to complete a diary;
- Cancer pain is expected to be relatively stable and last for more than 48 hours;
- The patient understands the research process, agrees to participate in the trial, cooperates with the treatment and visit plan, and signs an informed consent form.
Who cannot join
- Known allergy to any ingredient in both fentanyl and morphine;
- No cancer associated pain or the pain of unknown cause, such as osteoarthritis pain, acute abdominal pain;
- Primary tumors or metastases in the brain;
- An active skin disease that precluded application of the transdermal system;
- Anti-cancer therapy (radiotherapy, chemotherapy, targeted therapy, etc.) is used during the study period, and the treatment has an impact on the analgesic effect or adverse reactions of analgesic drugs;
- No bowel movement within 3 days before the screening period;
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- The patient has contraindications to the use of opioids: such as respiratory depression; head damage; paralytic intestinal obstruction; acute abdomen; chronic obstructive airway disease; pulmonary heart disease; chronic bronchial asthma; hypercapnia;
- Used monoamine oxidase inhibitor within 1 week before randomization;
- Any abnormal laboratory test results with obvious clinical significance, such as creatinine value ≥ 2 times the high limit of the normal value or ALT or AST ≥ 2.5 times the high limit of the normal value (for patients with liver metastases can be relaxed to ≥ 5 times the high limit of the normal value) ;
- Patients with a history of drug abuse;
- Patients with mental illness or cognitive impairment;
- Pregnant or lactating women; subjects who have a pregnancy plan within 1 month after the test (including male subjects);
- Participate in the drug trial (including the trial drug) within 3 months before the trial.
About this study
Official title: Opioid Titration With 12.5 ug/h Fentanyl Transdermal Patch vs Orally Morphine for Opioid-naïve Patients With Moderate Cancer Pain: A Prospective, Randomized, Controlled, Multi-center, Phase III Trial
Opioid is recommended for moderate cancer pain in WHO 3-step analgesic ladder. Transdermal administration of the strong opioid fentanyl was originally developed for patients unable to swallow analgesics because of malignancies in the head and neck region or the gastrointestinal tract, painful lesions in the mouth, or periods of nausea, vomiting, or bowel obstruction. The EMA recognizes that in exceptional clinical circumstances, the 12 μg/h fentanyl patch could be considered. To our knowledge, there is not a phase III trial to explore the efficacy and safety of 12 μg/h fentanyl patch in opioid-naive patients with moderate cancer pain.
- Being tested
- 2.5ug/h transdermal fentanyl, Oral immediate-released morphine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2.5ug/h transdermal fentanylDrug
2.5ug/h transdermal fentanyl administers for opioid-naive patients with moderate cancer pain very 3 days
Oral immediate-released morphineDrug
5mg immediate-released morphine every 4 hours, double dose before sleep.
| Study group | Role | What they receive |
|---|---|---|
| 2.5ug/h transdermal fentanyl | Experimental | Not described Receives: Drug: 2.5ug/h transdermal fentanyl |
| Oral immediate-released morphine | Active comparator | Not described Receives: Drug: Oral immediate-released morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of responder patients
the number of responder patients is defined as patientswith a 20% reduction in pain intensity on the numerical rating scale.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start1 Sep 2020 (estimated)
- Primary completion31 Aug 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid, Moderate Cancer Pain, Transdermal Fentanyl, 12.5ug/h, Opioid-naiveStudies of the same condition, open and under way.
- More trials run by Fujian Cancer HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 209 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04533243
- Sponsor's protocol ID
- SYLT-19
- Status last verified
- Aug 2020
- First submitted
- 26 Aug 2020
- Last updated
- 31 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid Titration With 12.5 ug/h Fentanyl Transdermal Patch vs Orally Morphine for Opioid-naïve Patients With Moderate Cancer Pain: A Prospective, Randomized, Controlled, Multi-center, Phase III Trial
- ClinicalTrials.gov ID
- NCT04533243
- Acronym / sponsor ID
- SYLT-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 209 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 31 Aug 2020 (actual)
- 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.
Opioid is recommended for moderate cancer pain in WHO 3-step analgesic ladder. Transdermal administration of the strong opioid fentanyl was originally developed for patients unable to swallow analgesics because of malignancies in the head and neck region or the gastrointestinal tract, painful lesions in the mouth, or periods of nausea, vomiting, or bowel obstruction. The EMA recognizes that in exceptional clinical circumstances, the 12 μg/h fentanyl patch could be considered. To our knowledge, there is not a phase III trial to explore the efficacy and safety of 12 μg/h fentanyl patch in opioid-naive patients with moderate cancer pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2.5ug/h transdermal fentanyl | Experimental | Drug: 2.5ug/h transdermal fentanyl |
| Oral immediate-released morphine | Active comparator | Drug: Oral immediate-released morphine |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18 years old or more;
- ECOG PS ≤3 ;
- Opioid tolerance not moderate pain patients (4≤ NRS ≤6 on 11 points, 0 no pain, 10 most pain);
- No taking strong opioids for the last 30 days;
- Estimated life expectancy of at least 3 months;
Key exclusion criteria (13 listed)
- Known allergy to any ingredient in both fentanyl and morphine;
- No cancer associated pain or the pain of unknown cause, such as osteoarthritis pain, acute abdominal pain;
- Primary tumors or metastases in the brain;
- An active skin disease that precluded application of the transdermal system;
- Anti-cancer therapy (radiotherapy, chemotherapy, targeted therapy, etc.) is used during the study period, and the treatment has an impact on the analgesic effect or adverse reactions of analgesic drugs;
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 |
|---|---|---|
| 2.5ug/h transdermal fentanyl2.5ug/h transdermal fentanyl administers for opioid-naive patients with moderate cancer pain very 3 days | Drug | 2.5ug/h transdermal fentanyl |
| Oral immediate-released morphine5mg immediate-released morphine every 4 hours, double dose before sleep. | Drug | Oral immediate-released morphine |
Primary outcome
the number of responder patients
Time frame: 12 months
the number of responder patients is defined as patientswith a 20% reduction in pain intensity on the numerical rating scale.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2020.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 2.5ug/h transdermal fentanyl and Oral immediate-released morphine in people with Opioid, Moderate Cancer Pain, Transdermal Fentanyl, 12.5ug/h, Opioid-naive, run by Fujian Cancer Hospital.
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 9 inclusion and 13 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 31 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
the number of responder patients (time frame: 12 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 31 Aug 2020.