PainPhase 3NCT05297669

A Phase # 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.

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

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 postoperative pain in gynecology.main purpose is to evaluate the efficacy of Felbinac Trometamol Injection in the treatment of moderate and severe… 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: 264 participants
Where: 1 siteChina
Study dates: 23 Jul 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)];
Patients who intend to undergo laparotomy or laparoscopic total or subtotal hysterectomy (with or without salpingectomy and oophorectomy) under elective general anesthesia;
Expected hospital stay ≥48 hours after surgery；
Expected to require more than 24 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 investigators;
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 fibrosis bronchial asthma, 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 within 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;
Known to be allergic to multiple drugs in the past, or allergic to the components of this drug, NSAIDs, opioids;
Patients who are afflicted with narcotic drugs, drugs, or resistant to opioids;
History of alcohol abuse within one year prior to screening
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

Other trials in China

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 Postoperative Pain in Gynecology

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 and 16h after the start of the first dose,the first intravenous infusion was started at 30±5 minutes before the end of the operation (Skin suture completes the last stitch).The drug was given 3 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 and 16h after the start of the first dose, the first intravenous infusion was started at 30±5 minutes before the end of the operation (Skin suture completes the last stitch).The drug was given 3 times,3 times/day, once every 8 hours.

Study groups in NCT05297669
Study group	Role	What they receive
group1	Experimental	Generic name: Felbinac Trometamol Injection; Dosage form: Injection Dosage:94.25mg Volume:4ml Frequency:Multi-dose Duration:1 day. A total of 132 subjects received the test drug . Receives: Drug: Felbinac Trometamol Injection
group2	Placebo comparator	Placebo:Normal saline Dosage form:Injection Dosage:0mg Volume:0ml Frequency:Multi-dose Duration:1 day A total of 132 subjects received the placebo. Receives: Drug: Placebos

What is being measured

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

24 hours (h) total morphine consumption
The total amount of morphine within 24 hours after the end of first drug administration
Measured: up to 24 hours after multi-dose

Secondary outcomes (5)

Area under the pain intensity curve during movement (AUCM)
Pain intensity under movement Pain intensity under movement
Measured: 1-8 hours (h) ，8-16 h，16-24 (within 24 hours after the end of first drug administration）
Area under the pain intensity curve during rest(AUCR)
Pain intensity under rest
Measured: 1-8 hours (h) ，8-16 h，16-24 h（within 24 hours after the end of first drug administration）
Press time
The first time to press the analgesic pump for analgesia
Measured: up to 24 hours after multi-dose
Total and effective pressing times of analgesic pump within 24 hours after the first administration
Total and effective pressing times of analgesic pump within 24 hours after the first administration
Measured: up to 24 hours after multi-dose
The proportion of morphine used to remedy analgesia.
The proportion of morphine used to remedy analgesia.
Measured: up to 24 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.

23 Jul 202130 Jun 2022

First posted28 Mar 2022
Study start23 Jul 2021
Primary completion19 Jan 2022
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: 264 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05297669
Sponsor's protocol ID: BALF-PAIN-3002
Status last verified: May 2023
First submitted: 9 Mar 2022
Last updated: 22 May 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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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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 Postoperative Pain in Gynecology
ClinicalTrials.gov ID: NCT05297669
Acronym / sponsor ID: BALF-PAIN-3002
Conditions: Pain
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 264 participants (actual)
Lead sponsor: Shijiazhuang Yiling Pharmaceutical Co. LtdIndustry (pharma, biotech, devices)
Study start: 23 Jul 2021 (actual)
Primary completion: 19 Jan 2022 (actual)
Study completion: 30 Jun 2022 (actual)
First posted: 28 Mar 2022 (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.

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
group1	Experimental	Drug: Felbinac Trometamol InjectionGeneric name: Felbinac Trometamol Injection; Dosage form: Injection Dosage:94.25mg Volume:4ml Frequency:Multi-dose Duration:1 day. A total of 132 subjects received the test drug .
group2	Placebo comparator	Drug: PlacebosPlacebo:Normal saline Dosage form:Injection Dosage:0mg Volume:0ml Frequency:Multi-dose Duration:1 day A total of 132 subjects received the placebo.

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)];
Patients who intend to undergo laparotomy or laparoscopic total or subtotal hysterectomy (with or without salpingectomy and oophorectomy) under elective general anesthesia;
Expected hospital stay ≥48 hours after surgery；

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 and 16h after the start of the first dose,the first intravenous infusion was started at 30±5 minutes before the end of the operation (Skin suture completes the last stitch).The drug was given 3 times,3 times/day, once every 8 hours.	Drug	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 and 16h after the start of the first dose, the first intravenous infusion was started at 30±5 minutes before the end of the operation (Skin suture completes the last stitch).The drug was given 3 times,3 times/day, once every 8 hours.	Drug	group2

Primary outcome

24 hours (h) total morphine consumption
Time frame: up to 24 hours after multi-dose
The total amount of morphine within 24 hours after the end of first drug administration

5 secondary outcomes

Area under the pain intensity curve during movement (AUCM)
Time frame: 1-8 hours (h) ，8-16 h，16-24 (within 24 hours after the end of first drug administration）
Area under the pain intensity curve during rest(AUCR)
Time frame: 1-8 hours (h) ，8-16 h，16-24 h（within 24 hours after the end of first drug administration）
Press time
Time frame: up to 24 hours after multi-dose
Total and effective pressing times of analgesic pump within 24 hours after the first administration
Time frame: up to 24 hours after multi-dose
The proportion of morphine used to remedy analgesia.
Time frame: up to 24 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.

Mengchang Gao, MD principal investigator

Sichuan Provincial People's Hospital

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?

24 hours (h) total morphine consumption (time frame: up to 24 hours after multi-dose). 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 NCT05297669.

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.