Cancer PainPhase 3NCT04785768
IV PCA With or Without Continuous Dose vs Oral Opioid to Maintain Analgesia for Severe Cancer Pain After Successful Titration
A Phase 3 study testing Hydromorphone Hydrochloride Injection and Morphine Sulfate Sustained-release Tablets in people with Cancer Pain, run by Fujian Cancer Hospital at 1 site in China.
Trial summary
Based on the previous HMORCT09-2, the results show that IV PCA for analgesia maintenance improvements control of severe cancer pain after successful titration. Therefore, a study is planned to further explore the difference of efficacy and safety between PCA with continuous + bolus dose versus bolus-only. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cancer Pain
- What is being tested?
- Hydromorphone Hydrochloride Injection and Morphine Sulfate Sustained-release Tablets
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,372 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2021to 1 Jul 2024
- 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 to 80 years;
- Histologically or cytologically confirmed malignant solid tumor;
- Persistent severe cancer-related pain (≥7 at rest on the 11-point numeric rating scale [NRS], where 0=no pain and 10=excruciating pain) in the 24 hours before screening;
- No radiotherapy to the painful area prior to randomization;
- No radiotherapy, chemotherapy, hormone therapy, targeted therapy, or bisphosphonate therapy within 7 days before randomization;
- Successful IPCA-HM titration within the past 24 hours;
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- No history of psychiatric disorders;
- Ability to complete questionnaires;
- Ability to correctly understand and follow medication guidance from doctors and nurses;
- ECOG performance status ≤ 3;
- Provided written informed consent. Exclusion Criteria
- 1) Patients with non-cancer-related pain; 2) Patients with paralytic ileus; 3) Patients with brain metastases; 4) Patients with hypersensitivity to morphine or hydromorphone; 5) Abnormal laboratory results: creatinine ≥ 2-fold of upper limit of normal (ULN) value, Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) ≥ 2.5-fold of the ULN value (≥ 5-fold for subjects with liver metastasis or primary liver cancer), or Child-Pugh class C liver function; 6) Patients unable to take oral medication; 7) Patients with uncontrolled nausea or vomiting; 8) Prior use of hydromorphone, morphine, or PCA devices within 14 days before screening; 9) Use of monoamine oxidase inhibitor drugs (MAOID) within the two weeks before randomization; 10) Women who are pregnant, lactating, or planning to be pregnant within one month after the trial completion; 11) Patients who abuse alcohol; 12) Patients with any other medical condition or reason, in the investigator's judgment, that would make them unsuitable to participate in the clinical trial.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intravenous (IV) Patient Controlled Analgesia (PCA) With or Without Continuous Dose vs Oral Opioid to Maintain Analgesia for Severe Cancer Pain After Successful Hydromorphone Titration: a Multi-center, Phase Ⅲ ，Randomized Trial
Based on the previous HMORCT09-2, the results show that IV PCA for analgesia maintenance improvements control of severe cancer pain after successful titration. Therefore, a study is planned to further explore the difference of efficacy and safety between PCA with continuous + bolus dose versus bolus-only.
- Conditions
- Cancer Pain
- Being tested
- Hydromorphone Hydrochloride Injection, Morphine Sulfate Sustained-release Tablets
- Keywords
- Orally, IV PCA with continuous + bolus dose, IV PCA with bolus-only dose
- Medical subject headings
- Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydromorphone Hydrochloride InjectionDrug
Intravenous PCA with hydromorphone after successful titration of 24 hours.the PCA setting: 1) continuous dose (dose/hours) = the total dosage of hydromorphone in the previous 24 hours/24; 2) bolus dose = 10-20% of the total dosage of hydromorphone in the previous 24 hours; 3) lockout time = 10 minutes; 4）Evaluate every 24 hours and PCA parameters were adjusted according to the dose of the previous day.
Hydromorphone Hydrochloride InjectionDrug
Intravenous PCA with hydromorphone after successful titration of 24 hours.the PCA setting: 1) continuous dose = 0; 2) bolus dose = 10-20% of the total dosage of hydromorphone in the previous 24 hours: 3) lockout time = 10 minutes; 4)Evaluate every 24 hours and PCA parameters were adjusted according to the dose of the previous day.
Morphine Sulfate Sustained-release TabletsDrug
Swift to sustained-release morphine orally as background dose with immediate release morphine orally for breakthrough pain after successful titration of 24 hours.
Administration of morphine orally 1) Sustained-release morphine orally (dose/12 hours) = the total equianalgesic of the previous 24 hours/2×75% for day 1; 2）the total equianalgesic of the previous 24 hours/2 for day 2 ; 3）Evaluate every 24 hours and the dose for the next day is adjusted according to the dose of the previous day；4) Immediate release morphine orally = 10-20% of the total equianalgesic of the previous 24 hours;
| Study group | Role | What they receive |
|---|---|---|
| PCA with continuous + bolus dose | Experimental | （1）Intravenous PCA with hydromorphone after successful titration of 24 hours;（2）PCA hydromorphone with continuous infusion where dose/h was the total equianalgesic over the previous 24h divided by 24 and bolus dosage for breakthrough pain was 10%-20% of the total equianalgesic over the previous 24h；lockout time = 10 minutes；（3）Evaluate every 24 hours and PCA parameters were adjusted according to the dose of the previous day; (4)The treatment regimen was continued for 7 days. Receives: Drug: Hydromorphone Hydrochloride Injection |
| PCA with bolus-only dose | Experimental | （1）Intravenous PCA with hydromorphone after successful titration of 24 hours; (2)PCA hydromorphone with bolus-only where dosage was 10%-20% of the total equianalgesic over the previous 24h administrated as needed;（3）Evaluate every 24 hours and PCA parameters were adjusted according to the dose of the previous day; (4)The treatment regimen was continued for 7 days. Receives: Drug: Hydromorphone Hydrochloride Injection |
| Oral opioid | Active comparator | （1）Swift to sustained-release morphine orally as background dose with immediate release morphine orally for breakthrough pain after successful titration of 24 hours；(2)Oral sustained-released morphine where total equianalgesic over the previous 24h/2×75% every 12h/day and immediate-release morphine for breakthrough pain was 10%-20% of the total equianalgesic over the previous 24h； (3)Evaluate every 24 hours and the dose for the next day is adjusted according to the dose of the previous day；(4)The treatment regimen was continued for 7 days. Receives: Drug: Morphine Sulfate Sustained-release Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
3DNRS (3-day average Numeric Rating Scale)
The Numerical Rating Scale (NRS, a score of 0 means no pain and 10 means the most severe) is used to assess the severity of pain. NRS of 24 hours is assessed every day. 3DNRS is a sum of average NRS of Day 1 (D 1) to Day 3 divided by 3 (the day of titration is defined as D0, the first day after titration is defined as D1, the second day after titration is defined as D2, and so on).
Measured: up to 4 days
Secondary outcomes (10)
Daily avNRS score of days 1 to 6
Daily average NRS pain score of days 1 to 6
Measured: up to 7 days
Adverse events
assessed by NCI-CTCAE v5.0
Measured: up to 8 days
Improvement in physical symptoms and overall well-being
assessed by Chinese version of the Edmonton Symptom Assessment System.
Measured: up to 7 days
Patient Satisfaction Score
The satisfaction score of the patients to analgesia was evaluated by 10-point scale: 0 points for dissatisfaction, 10 points for very satisfied, the higher the score, the higher the satisfaction.
Measured: up to 7 days
Daily equivalent morphine consumption
Daily equivalent morphine consumption
Measured: up to 7 days
Number of patients with an average NRS pain score > 6
The Numerical Rating Scale (NRS, a score of 0 means no pain and 10 means the most severe) is used to assess the severity of pain.
Measured: up to 7 days
Number of patients with an average NRS pain score >3
The Numerical Rating Scale (NRS, a score of 0 means no pain and 10 means the most severe) is used to assess the severity of pain.
Measured: up to 7 days
Patient Satisfaction Score
from 0 to 10, with 0 = extremely unsatisfied and 10 = extremely satisfied
Measured: up to 7 days
Maximum NRS (Days 1 to 6)
Maximum NRS score (Days 1 to 6)
Measured: up to 7 days
Daily frequency and duration of breakthrough cancer pain
Daily frequency and duration of breakthrough cancer pain (defined as transient pain exacerbation [NRS ≥4])
Measured: up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start1 Jul 2021
- Primary completion1 May 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,372 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Rong bo Lin, MD, Principal investigator, Fujian Cancer Hospital,Department of Gastrointestinal Medical Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04785768
- Sponsor's protocol ID
- SYLT021/HMORCT09-3
- Status last verified
- May 2025
- First submitted
- 3 Mar 2021
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anonymized individual participant data and supporting clinical trial documents, including the study protocol, informed consent forms, and statistical analysis plan, will be available upon reasonable request to the corresponding author
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous (IV) Patient Controlled Analgesia (PCA) With or Without Continuous Dose vs Oral Opioid to Maintain Analgesia for Severe Cancer Pain After Successful Hydromorphone Titration: a Multi-center, Phase Ⅲ ，Randomized Trial
- ClinicalTrials.gov ID
- NCT04785768
- Acronym / sponsor ID
- SYLT021/HMORCT09-3
- Conditions
- Cancer Pain
- Keywords
- Orally, IV PCA with continuous + bolus dose, IV PCA with bolus-only dose
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,372 participants (actual)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 8 Mar 2021 (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.
Based on the previous HMORCT09-2, the results show that IV PCA for analgesia maintenance improvements control of severe cancer pain after successful titration. Therefore, a study is planned to further explore the difference of efficacy and safety between PCA with continuous + bolus dose versus bolus-only.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PCA with continuous + bolus dose | Experimental | Drug: Hydromorphone Hydrochloride Injection（1）Intravenous PCA with hydromorphone after successful titration of 24 hours;（2）PCA hydromorphone with continuous infusion where dose/h was the total equianalgesic over the previous 24h divided by 24 and bolus dosage for breakthrough pain was 10%-20% of the total equianalgesic over the previous 24h；lockout time = 10 minutes；（3）Evaluate every 24 hours and PCA parameters were adjusted according to the dose of the previous day; (4)The treatment regimen was continued for 7 days. |
| PCA with bolus-only dose | Experimental | Drug: Hydromorphone Hydrochloride Injection（1）Intravenous PCA with hydromorphone after successful titration of 24 hours; (2)PCA hydromorphone with bolus-only where dosage was 10%-20% of the total equianalgesic over the previous 24h administrated as needed;（3）Evaluate every 24 hours and PCA parameters were adjusted according to the dose of the previous day; (4)The treatment regimen was continued for 7 days. |
| Oral opioid | Active comparator | Drug: Morphine Sulfate Sustained-release Tablets（1）Swift to sustained-release morphine orally as background dose with immediate release morphine orally for breakthrough pain after successful titration of 24 hours；(2)Oral sustained-released morphine where total equianalgesic over the previous 24h/2×75% every 12h/day and immediate-release morphine for breakthrough pain was 10%-20% of the total equianalgesic over the previous 24h； (3)Evaluate every 24 hours and the dose for the next day is adjusted according to the dose of the previous day；(4)The treatment regimen was continued for 7 days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age 18 to 80 years;
- Histologically or cytologically confirmed malignant solid tumor;
- Persistent severe cancer-related pain (≥7 at rest on the 11-point numeric rating scale [NRS], where 0=no pain and 10=excruciating pain) in the 24 hours before screening;
- No radiotherapy to the painful area prior to randomization;
- No radiotherapy, chemotherapy, hormone therapy, targeted therapy, or bisphosphonate therapy within 7 days before randomization;
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Hydromorphone Hydrochloride InjectionIntravenous PCA with hydromorphone after successful titration of 24 hours.the PCA setting: 1) continuous dose (dose/hours) = the total dosage of hydromorphone in the previous 24 hours/24; 2) bolus dose = 10-20% of the total dosage of hydromorphone in the previous 24 hours; 3) lockout time = 10 minutes; 4）Evaluate every 24 hours and PCA parameters were adjusted according to the dose of the previous day. | Drug | PCA with continuous + bolus dose |
| Hydromorphone Hydrochloride InjectionIntravenous PCA with hydromorphone after successful titration of 24 hours.the PCA setting: 1) continuous dose = 0; 2) bolus dose = 10-20% of the total dosage of hydromorphone in the previous 24 hours: 3) lockout time = 10 minutes; 4)Evaluate every 24 hours and PCA parameters were adjusted according to the dose of the previous day. | Drug | PCA with bolus-only dose |
| Morphine Sulfate Sustained-release TabletsSwift to sustained-release morphine orally as background dose with immediate release morphine orally for breakthrough pain after successful titration of 24 hours. Administration of morphine orally 1) Sustained-release morphine orally (dose/12 hours) = the total equianalgesic of the previous 24 hours/2×75% for day 1; 2）the total equianalgesic of the previous 24 hours/2 for day 2 ; 3）Evaluate every 24 hours and the dose for the next day is adjusted according to the dose of the previous day；4) Immediate release morphine orally = 10-20% of the total equianalgesic of the previous 24 hours; | Drug | Oral opioid |
Primary outcome
3DNRS (3-day average Numeric Rating Scale)
Time frame: up to 4 days
The Numerical Rating Scale (NRS, a score of 0 means no pain and 10 means the most severe) is used to assess the severity of pain. NRS of 24 hours is assessed every day. 3DNRS is a sum of average NRS of Day 1 (D 1) to Day 3 divided by 3 (the day of titration is defined as D0, the first day after titration is defined as D1, the second day after titration is defined as D2, and so on).
10 secondary outcomes
Daily avNRS score of days 1 to 6
Time frame: up to 7 days
Adverse events
Time frame: up to 8 days
Improvement in physical symptoms and overall well-being
Time frame: up to 7 days
Patient Satisfaction Score
Time frame: up to 7 days
Daily equivalent morphine consumption
Time frame: up to 7 days
Number of patients with an average NRS pain score > 6
Time frame: up to 7 days
Number of patients with an average NRS pain score >3
Time frame: up to 7 days
Patient Satisfaction Score
Time frame: up to 7 days
Maximum NRS (Days 1 to 6)
Time frame: up to 7 days
Daily frequency and duration of breakthrough cancer pain
Time frame: up to 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Individual participant dataSharing planned: Undecided. Anonymized individual participant data and supporting clinical trial documents, including the study protocol, informed consent forms, and statistical analysis plan, will be available upon reasonable request to the corresponding author
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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.
Rong bo Lin, MD principal investigator
Fujian Cancer Hospital,Department of Gastrointestinal Medical Oncology
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 Hydromorphone Hydrochloride Injection and Morphine Sulfate Sustained-release Tablets in people with Cancer Pain, run by Fujian Cancer Hospital at 1 site in China.
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 12 inclusion and 0 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 22 May 2025. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
3DNRS (3-day average Numeric Rating Scale) (time frame: up to 4 days). 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 22 May 2025.