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

NCT04526132 | Completed Phase 3

• 1 other identifier: BALF-PAIN-3001
• Study Type: interventional
• Target: 306
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• 24h total morphine consumption

  The total amount of morphine within 24 hours after the end of first drug administration

  up to 24hours after multi-dose

Secondary Outcomes (8)

• Area under the pain intensity curve during movement (AUCM)

  0-8 h，8-16 h，16-24 h and 0-48 h

• Area under the pain intensity curve during rest(AUCR)

  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

  up to 48 hours after multi-dose

• Pain intensity at 48 hours after the end of the first administration under rest

  up to 48 hours after multi-dose

• Press time

  up to 48 hours after multi-dose

Study Arms (2)

Experimental: group1

EXPERIMENTAL

Generic name: Felbinac Trometamol Injection; Placebo:Normal saline Dosage form: Injection Dosage:8ml Volume:4ml

Drug: Felbinac Trometamol Injection

Experimental: group2

PLACEBO COMPARATOR

Generic name:Placebo Placebo:Normal saline Dosage form:Injection Dosage:8mg Volume:4ml

Drug: Placebos

Interventions

Felbinac Trometamol Injection DRUG

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.

Also known as: 4-Biphenylacetic Acid Trishydroxymettiylaminometnane

Experimental: group1

Placebos DRUG

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.

Also known as: Normal saline

Experimental: group2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≤age≤65 years of age, gender is not limited;
• ASA grade I or II;
• ≤ 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.

You may not qualify if:

• 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);
• 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;

Sponsors & Collaborators

• Shijiazhuang Yiling Pharmaceutical Co. Ltd: lead

Study Sites (1)

Shijiazhuang Yiling Pharmaceutical Co.,Ltd

Shijiazhuang, Hebei, 050036, China

Location

MeSH Terms

Conditions

Pain

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Wen Ouyang, MD

  The Third Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2020
• First Posted: August 25, 2020
• Study Start: April 25, 2021
• Primary Completion: December 29, 2021
• Study Completion: June 30, 2022
• Last Updated: May 22, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)