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

NCT03872830 | Completed Phase 2

• 1 other identifier: BALF-PAIN-2001
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

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 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

Outcome Measures

Primary Outcomes (1)

• 24h total morphine consumption

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

  up to 24hours after multi-dose

Secondary Outcomes (4)

• Area under the pain intensity curve(AUC)

  up to 24 hours after multi-dose

• Press time

  up to 24 hours after multi-dose

• Total number of analgesia pump presses

  up to 24 hours after multi-dose

• The number of effective presses of analgesia pump

  up to 24 hours after multi-dose

Study Arms (4)

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 .

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 .

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 .

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.

Drug: Placebos

Interventions

Felbinac Trometamol Injection DRUG

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.

Experimental: group1; Experimental: group2; Experimental: group3

Placebos DRUG

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.

Experimental: group4

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 \[BMI = weight (kg) / height 2 (m2)\];
• 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.

You may not qualify if:

• 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;

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

Condition Hierarchy (Ancestors)

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

Study Officials

• Wen Ouyang, MD

  The Third Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: March 6, 2019
• First Posted: March 13, 2019
• Study Start: March 27, 2019
• Primary Completion: September 30, 2019
• Study Completion: December 5, 2019
• Last Updated: July 7, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)