PainPhase 2NCT03872830

A Phase Ⅱ Clinical Study Trial of Felbinac Trometamol Injection in China

A Phase 2 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

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: 165 participants
Where: 1 siteChina
Study dates: 27 Mar 2019to 5 Dec 2019
Phase: Phase 2
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)];
Inpatients who underwent open surgery under elective general anesthesia (including gallbladder, intestinal or lower abdominal surgery, etc.), or laparoscopic surgery with a single surgical incision ≥ 5 cm;
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 researchers;
Agree to participate in the trial and voluntarily sign the informed consent form.

Who cannot join

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 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(See Annex 1).
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 bronchial asthma, pulmonary heart disease or other serious respiratory diseases;
Person with gastrointestinal ulcer and a history of gastrointestinal bleeding 6 weeks before operation and required medical treatment;
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

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-exploratory Phase II Clinical Trial to Evaluating the Efficacy and Safety of Felbinac Trometamol Injection in the Treatment of Moderate to Severe Pain After Surgery

A multicenter, randomized, double-blind, placebo-controlled, dose-exploratory phase II clinical trial to evaluating the efficacy and safety of Felbinac Trometamol Injection in the treatment of moderate to severe pain after surgery.Main purpose is preliminary evaluation the effectiveness of Felbinac Trometamol Injection in the treatment of moderate and severe pain after surgery.Secondary purpose is to explore the dosage regimen of Felbinac Trometamol Injection in the treatment of moderate and severe pain after surgery, and provide data support for later clinical trial.

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
Felbinac Trometamol Injection diluted to 100 ml with 0.9% sodium chloride injection,a 30-minute period using a Microinjection pump.
One dose at 8h and 16h 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 3 times,3 times/day,once every 8 hours.
PlacebosDrug
Placebo diluted to 100 ml with 0.9% sodium chloride injection,a 30-minute period using a Microinjection pump.
One dose at 8h and 16h 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 3 times,3 times/day,once every 8 hours.

Study groups in NCT03872830
Study group	Role	What they receive
Experimental: group1	Experimental	Generic name:Felbinac Trometamol Injection; Placebo:normal saline Dosage form:Injection Dosage:47.13mg Volume:2ml Frequency:Multi-dose Duration:1 day. A total of 40 subjects,40 received the test drug . Receives: Drug: Felbinac Trometamol Injection
Experimental: group2	Experimental	Generic name:Felbinac Trometamol Injection; Placebo:normal saline Dosage form:Injection Dosage:94.25mg Volume:4ml Frequency:Multi-dose Duration:1 day. A total of 40 subjects,40 received the test drug . Receives: Drug: Felbinac Trometamol Injection
Experimental: group3	Experimental	Generic name:Felbinac Trometamol Injection; Placebo:normal saline Dosage form:Injection Dosage:188.5mg Volume:8ml Frequency:Multi-dose Duration:1 day. A total of 40 subjects,40 received the test drug . Receives: Drug: Felbinac Trometamol Injection
Experimental: group4	Placebo comparator	Generic name:Placebo; Placebo:normal saline Dosage form:Injection Dosage:4ml/injection Volume:10ml Frequency:Multi-dose Duration:1 day. A total of 40 subjects,40 received the placebo. 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 the total amount of morphine within 24 hours after the end of first drug administration
Measured: up to 24hours after multi-dose

Secondary outcomes (4)

Area under the pain intensity curve(AUC)
Pain intensity under exercise/rest state - area under the time curve
Measured: up to 24 hours after multi-dose
Press time
The first time to press the analgesic pump for analgesia
Measured: up to 24 hours after multi-dose
Total number of analgesia pump presses
Total number of analgesic pump presses within 24 hours after the first dose
Measured: up to 24 hours after multi-dose
The number of effective presses of analgesia pump
The number of effective presses of analgesia pump within 24 hours after the end of the first dose
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.

27 Mar 20195 Dec 2019

First posted13 Mar 2019
Study start27 Mar 2019
Primary completion30 Sep 2019
Study completion5 Dec 2019

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 165 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03872830
Sponsor's protocol ID: BALF-PAIN-2001
Status last verified: Jul 2020
First submitted: 6 Mar 2019
Last updated: 7 Jul 2020
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 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-exploratory Phase II Clinical Trial to Evaluating the Efficacy and Safety of Felbinac Trometamol Injection in the Treatment of Moderate to Severe Pain After Surgery
ClinicalTrials.gov ID: NCT03872830
Acronym / sponsor ID: BALF-PAIN-2001
Conditions: Pain
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 165 participants (actual)
Lead sponsor: Shijiazhuang Yiling Pharmaceutical Co. LtdIndustry (pharma, biotech, devices)
Study start: 27 Mar 2019 (actual)
Primary completion: 30 Sep 2019 (actual)
Study completion: 5 Dec 2019 (actual)
First posted: 13 Mar 2019 (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: 4

Arm	Type	Receives
Experimental: group1	Experimental	Drug: Felbinac Trometamol InjectionGeneric name:Felbinac Trometamol Injection; Placebo:normal saline Dosage form:Injection Dosage:47.13mg Volume:2ml Frequency:Multi-dose Duration:1 day. A total of 40 subjects,40 received the test drug .
Experimental: group2	Experimental	Drug: Felbinac Trometamol InjectionGeneric name:Felbinac Trometamol Injection; Placebo:normal saline Dosage form:Injection Dosage:94.25mg Volume:4ml Frequency:Multi-dose Duration:1 day. A total of 40 subjects,40 received the test drug .
Experimental: group3	Experimental	Drug: Felbinac Trometamol InjectionGeneric name:Felbinac Trometamol Injection; Placebo:normal saline Dosage form:Injection Dosage:188.5mg Volume:8ml Frequency:Multi-dose Duration:1 day. A total of 40 subjects,40 received the test drug .
Experimental: group4	Placebo comparator	Drug: PlacebosGeneric name:Placebo; Placebo:normal saline Dosage form:Injection Dosage:4ml/injection Volume:10ml Frequency:Multi-dose Duration:1 day. A total of 40 subjects,40 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 (7 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)];
Inpatients who underwent open surgery under elective general anesthesia (including gallbladder, intestinal or lower abdominal surgery, etc.), or laparoscopic surgery with a single surgical incision ≥ 5 cm;
Expected to require more than 24 hours of PCIA( patient controlled intravenous analgesia) treatment after surgery ;

Key exclusion criteria (17 listed)

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 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(See Annex 1).
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 InjectionFelbinac Trometamol Injection diluted to 100 ml with 0.9% sodium chloride injection,a 30-minute period using a Microinjection pump. One dose at 8h and 16h 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 3 times,3 times/day,once every 8 hours.	Drug	Experimental: group1, Experimental: group2, Experimental: group3
PlacebosPlacebo diluted to 100 ml with 0.9% sodium chloride injection,a 30-minute period using a Microinjection pump. One dose at 8h and 16h 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 3 times,3 times/day,once every 8 hours.	Drug	Experimental: group4

Primary outcome

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

4 secondary outcomes

Area under the pain intensity curve(AUC)
Time frame: up to 24 hours after multi-dose
Press time
Time frame: up to 24 hours after multi-dose
Total number of analgesia pump presses
Time frame: up to 24 hours after multi-dose
The number of effective presses of analgesia pump
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 7 Jul 2020.
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 2 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 7 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 7 Jul 2020. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

On the ClinicalTrials.gov record for NCT03872830.

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 7 Jul 2020.