PainPhase 3NCT04526132
A Phase Ⅲ Clinical Study Trial of Felbinac Trometamol Injection in China
A Phase 3 study testing Felbinac Trometamol Injection in people with Pain, run by Shijiazhuang Yiling Pharmaceutical Co. Ltd at 1 site in China.
Trial summary
A multi-center, randomized, double-blind, placebo parallel controlled phase Ⅲ clinical trial on the efficacy and safety of felbinac trometamol Injection in the treatment of moderate and severe postoperative pain.main purpose is to evaluate the efficacy of Felbinac Trometamol Injection in the treatment of moderate and… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain
- What is being tested?
- Felbinac Trometamol Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 306 participants
- Where
- 1 siteChina
- Study dates
- 25 Apr 2021to 30 Jun 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18≤age≤65 years of age, gender is not limited;
- ASA grade I or II;
- 18 ≤ body mass index (BMI) ≤ 30 [BMI = weight (kg) / height 2 (m2)];
- Expected hospital stay ≥72 hours after surgery；
- Patients planned to receive laparotomy or laparoscopic upper abdominal surgery with a single surgical incision ≥5 cm, thoracoscopic chest surgery (such as lung lobe resection surgery, lung wedge resection surgery, etc.),both under general anesthesia;
- Expected to require more than 48 hours of PCIA (patient controlled intravenous analgesia) treatment after surgery;
- Ability to understand research procedures and pain scales, operate PCIA devices, and communicate effectively with researchers;
- Agree to participate in the trial and voluntarily sign the informed consent form.
Who cannot join
- Except for the chronic pain caused by the target lesion of this operation, those who have a history of chronic pain for more than 3 months or who are undergoing regular analgesia for more than 3 months;
- Those who have used barbiturates within 20 days before surgery, those who used other analgesics, muscle relaxants or sedatives within 24 hours before operation (excluding those required for this operation), or those who used long-acting non-steroidal anti-inflammatory drugs (NSAIDs) within 12 hours, or those who used short-acting non-steroidal anti-inflammatory drugs (NSAIDs) within 6 hours before operation.
- A person with high bleeding risk, and also including who with congenital bleeding disorders (such as hemophilia), thrombocytopenia (PLT < 80 × 10 ∧ 9 / L), abnormal platelet function (such as idiopathic thrombocytopenic purpura, disseminated intravascular coagulation, congenital platelet dysfunction, etc.) or any clinically significant active bleeding, coagulopathy;
- A person who received full-dose anticoagulant therapy, activated protein C or thrombolytic drugs within 6 hours before surgery (except for heparin subcutaneous injection for preventive treatment);
- People with heart failure (NYHA grade III or IV), unstable angina pectoris, acute myocardial infarction, and severe arrhythmia within 6 months before surgery
- Hypertensive patients who have not been satisfactorily controlled by blood pressure (systolic blood pressure ≥160mmHg or diastolic blood pressure ≥105mmHg), or ACEI/diuretics for ≥30 days, or hypotension (systolic blood pressure <90mmHg);
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- People with pulmonary heart disease or other serious respiratory diseases that are not the purpose of this treatment;
- Person with gastrointestinal ulcer and a history of gastrointestinal bleeding 6 months before operation and required medical treatment(prophylactic medication or undiagnosed persons are not excluded);
- Those with previous cerebral arteriovenous malformations, cerebral aneurysms, brain tumors, or preoperative traumatic brain injury, intracranial surgery, history of stroke;
- Patients with poor glycemic control of diabetes (random blood glucose > 11.1mmol / L);
- Patients with autoimmune diseases, connective tissue diseases, etc. who need long-term use of adrenocortical hormone therapy;
- Abnormal liver and kidney function: ALT/AST> 2 times the upper limit of normal value, or creatinine> upper limit of normal value, or dialysis treatment within 28 days before surgery;
- Allergic constitution, or known to be allergic to this drug, NSAIDs, and opioids;
- Patients who are afflicted with narcotic drugs, drugs, or resistant to opioids;
- A woman who is breast-feeding or pregnant, who is unable or unwilling to follow the investigator's guidance during the study period and within 3 months after the last study treatment;
- Those who have participated in other clinical trials within 3 months before surgery;
- Investigators believe that it is not suitable for participating in this research.
Trial locations and contacts
1 site in 1 country.
China1 site
Shijiazhuang Yiling Pharmaceutical Co.,Ltd
Shijiazhuang, Hebei, 050036
About this study
Official title: A Multi-center, Randomized, Double-blind, Placebo Parallel Controlled Phase Ⅲ Clinical Trial on the Efficacy and Safety of Felbinac Trometamol Injection in the Treatment of Moderate and Severe Postoperative Pain
A multi-center, randomized, double-blind, placebo parallel controlled phase Ⅲ clinical trial on the efficacy and safety of felbinac trometamol Injection in the treatment of moderate and severe postoperative pain.main purpose is to evaluate the efficacy of Felbinac Trometamol Injection in the treatment of moderate and severe pain after surgery.Secondary purpose is to evaluation the safety of Felbinac Trometamol Injection in the treatment of moderate and severe pain after surgery.
- Conditions
- Pain
- Being tested
- Felbinac Trometamol Injection, Placebos
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Felbinac Trometamol InjectionDrug
Also called 4-Biphenylacetic Acid Trishydroxymettiylaminometnane
Felbinac Trometamol Injection diluted to 100 ml with 0.9% sodium chloride injection.Use a micro-injection pump to inject intravenously at a constant speed for 30 min (± 2 min)..
One dose at 8h、16h 、24h、32h and 40h after the start of the first dose,the first intravenous infusion was started at the end of the operation (Skin suture completes the last stitch).The drug was given 6 times,3 times/day,once every 8 hours.
PlacebosDrug
Also called Normal saline
Placebo diluted to 100 ml with 0.9% sodium chloride injection.Use a micro-injection pump to inject intravenously at a constant speed for 30 min (± 2 min).
One dose at 8h、16h 、24h、32h and 40h after the start of the first dose,the first intravenous infusion was started at the end of the operation (Skin suture completes the last stitch).The drug was given 6 times,3 times/day,once every 8 hours.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: group1 | Experimental | Generic name: Felbinac Trometamol Injection; Placebo:Normal saline Dosage form: Injection Dosage:8ml Volume:4ml Receives: Drug: Felbinac Trometamol Injection |
| Experimental: group2 | Placebo comparator | Generic name:Placebo Placebo:Normal saline Dosage form:Injection Dosage:8mg Volume:4ml Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
24h total morphine consumption
The total amount of morphine within 24 hours after the end of first drug administration
Measured: up to 24hours after multi-dose
Secondary outcomes (8)
Area under the pain intensity curve during movement (AUCM)
Pain intensity under movement
Measured: 0-8 h，8-16 h，16-24 h and 0-48 h
Area under the pain intensity curve during rest(AUCR)
Pain intensity under rest
Measured: 0-8 h，8-16 h，16-24 h and 0-48 h
Pain intensity at 48 hours after the end of the first administration under movement
Measured: up to 48 hours after multi-dose
Pain intensity at 48 hours after the end of the first administration under rest
Measured: up to 48 hours after multi-dose
Press time
The first time to press the analgesic pump for analgesia
Measured: up to 48 hours after multi-dose
Total and effective pressing times of analgesic pump
Measured: up to 24 and 48 hours after multi-dose
The proportion of morphine used to remedy analgesia
Measured: up to 24 and 48 hours after multi-dose
Total amount of morphine administered within 48 hours after the first administration
Measured: up to 48 hours after multi-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2020
- Study start25 Apr 2021
- Primary completion29 Dec 2021
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shijiazhuang Yiling Pharmaceutical Co. Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wen Ouyang, MD, Principal investigator, The Third Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04526132
- Sponsor's protocol ID
- BALF-PAIN-3001
- Status last verified
- May 2023
- First submitted
- 21 Aug 2020
- Last updated
- 22 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Placebo Parallel Controlled Phase Ⅲ Clinical Trial on the Efficacy and Safety of Felbinac Trometamol Injection in the Treatment of Moderate and Severe Postoperative Pain
- ClinicalTrials.gov ID
- NCT04526132
- Acronym / sponsor ID
- BALF-PAIN-3001
- Conditions
- Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- Shijiazhuang Yiling Pharmaceutical Co. LtdIndustry (pharma, biotech, devices)
- Study start
- 25 Apr 2021 (actual)
- Primary completion
- 29 Dec 2021 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 25 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.
A multi-center, randomized, double-blind, placebo parallel controlled phase Ⅲ clinical trial on the efficacy and safety of felbinac trometamol Injection in the treatment of moderate and severe postoperative pain.main purpose is to evaluate the efficacy of Felbinac Trometamol Injection in the treatment of moderate and severe pain after surgery.Secondary purpose is to evaluation the safety of Felbinac Trometamol Injection in the treatment of moderate and severe pain after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: group1 | Experimental | Drug: Felbinac Trometamol InjectionGeneric name: Felbinac Trometamol Injection; Placebo:Normal saline Dosage form: Injection Dosage:8ml Volume:4ml |
| Experimental: group2 | Placebo comparator | Drug: PlacebosGeneric name:Placebo Placebo:Normal saline Dosage form:Injection Dosage:8mg Volume:4ml |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18≤age≤65 years of age, gender is not limited;
- ASA grade I or II;
- 18 ≤ body mass index (BMI) ≤ 30 [BMI = weight (kg) / height 2 (m2)];
- Expected hospital stay ≥72 hours after surgery；
- Patients planned to receive laparotomy or laparoscopic upper abdominal surgery with a single surgical incision ≥5 cm, thoracoscopic chest surgery (such as lung lobe resection surgery, lung wedge resection surgery, etc.),both under general anesthesia;
Key exclusion criteria (17 listed)
- Except for the chronic pain caused by the target lesion of this operation, those who have a history of chronic pain for more than 3 months or who are undergoing regular analgesia for more than 3 months;
- Those who have used barbiturates within 20 days before surgery, those who used other analgesics, muscle relaxants or sedatives within 24 hours before operation (excluding those required for this operation), or those who used long-acting non-steroidal anti-inflammatory drugs (NSAIDs) within 12 hours, or those who used short-acting non-steroidal anti-inflammatory drugs (NSAIDs) within 6 hours before operation.
- A person with high bleeding risk, and also including who with congenital bleeding disorders (such as hemophilia), thrombocytopenia (PLT < 80 × 10 ∧ 9 / L), abnormal platelet function (such as idiopathic thrombocytopenic purpura, disseminated intravascular coagulation, congenital platelet dysfunction, etc.) or any clinically significant active bleeding, coagulopathy;
- A person who received full-dose anticoagulant therapy, activated protein C or thrombolytic drugs within 6 hours before surgery (except for heparin subcutaneous injection for preventive treatment);
- People with heart failure (NYHA grade III or IV), unstable angina pectoris, acute myocardial infarction, and severe arrhythmia within 6 months before surgery
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 |
|---|---|---|
| Felbinac Trometamol InjectionAlso: 4-Biphenylacetic Acid TrishydroxymettiylaminometnaneFelbinac Trometamol Injection diluted to 100 ml with 0.9% sodium chloride injection.Use a micro-injection pump to inject intravenously at a constant speed for 30 min (± 2 min).. One dose at 8h、16h 、24h、32h and 40h after the start of the first dose,the first intravenous infusion was started at the end of the operation (Skin suture completes the last stitch).The drug was given 6 times,3 times/day,once every 8 hours. | Drug | Experimental: group1 |
| PlacebosAlso: Normal salinePlacebo diluted to 100 ml with 0.9% sodium chloride injection.Use a micro-injection pump to inject intravenously at a constant speed for 30 min (± 2 min). One dose at 8h、16h 、24h、32h and 40h after the start of the first dose,the first intravenous infusion was started at the end of the operation (Skin suture completes the last stitch).The drug was given 6 times,3 times/day,once every 8 hours. | Drug | Experimental: group2 |
Primary outcome
24h total morphine consumption
Time frame: up to 24hours after multi-dose
The total amount of morphine within 24 hours after the end of first drug administration
8 secondary outcomes
Area under the pain intensity curve during movement (AUCM)
Time frame: 0-8 h，8-16 h，16-24 h and 0-48 h
Area under the pain intensity curve during rest(AUCR)
Time frame: 0-8 h，8-16 h，16-24 h and 0-48 h
Pain intensity at 48 hours after the end of the first administration under movement
Time frame: up to 48 hours after multi-dose
Pain intensity at 48 hours after the end of the first administration under rest
Time frame: up to 48 hours after multi-dose
Press time
Time frame: up to 48 hours after multi-dose
Total and effective pressing times of analgesic pump
Time frame: up to 24 and 48 hours after multi-dose
The proportion of morphine used to remedy analgesia
Time frame: up to 24 and 48 hours after multi-dose
Total amount of morphine administered within 48 hours after the first administration
Time frame: up to 48 hours after multi-dose
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 2023.
- Individual participant dataSharing planned: No
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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.
Wen Ouyang, MD principal investigator
The Third Xiangya Hospital of Central South University
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 Felbinac Trometamol Injection in people with Pain, run by Shijiazhuang Yiling Pharmaceutical Co. Ltd 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 8 inclusion and 17 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 2023. 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. Some participants in this study may receive a placebo. 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?
24h total morphine consumption (time frame: up to 24hours after multi-dose). 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 2023.