Status:
COMPLETED
A Phase Ⅱ Clinical Study Trial of Felbinac Trometamol Injection in China
Lead Sponsor:
Shijiazhuang Yiling Pharmaceutical Co. Ltd
Conditions:
Pain
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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 moderat...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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);
- 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.
Key Trial Info
Start Date :
March 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 5 2019
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT03872830
Start Date
March 27 2019
End Date
December 5 2019
Last Update
July 7 2020
Active Locations (1)
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1
Shijiazhuang Yiling Pharmaceutical Co.,Ltd
Shijiazhuang, Hebei, China, 050036