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

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ClinicalTrials.gov Identifier: NCT03872830
Recruitment Status : Not yet recruiting
First Posted : March 13, 2019
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Shijiazhuang Yiling Pharmaceutical Co. Ltd

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.

Condition or disease Intervention/treatment Phase
Pain Drug: Felbinac Trometamol Injection Drug: Placebos Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental: group1
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

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: Experimental: group2
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

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: Experimental: group3
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

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.


Placebo Comparator: Experimental: group4
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

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.





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Area under the pain intensity curve(AUC) [ Time Frame: up to 24 hours after multi-dose ]
    Pain intensity under exercise/rest state - area under the time curve

  2. Press time [ Time Frame: up to 24 hours after multi-dose ]
    The first time to press the analgesic pump for analgesia

  3. Total number of analgesia pump presses [ Time Frame: up to 24 hours after multi-dose ]
    Total number of analgesic pump presses within 24 hours after the first dose

  4. The number of effective presses of analgesia pump [ Time Frame: up to 24 hours after multi-dose ]
    The number of effective presses of analgesia pump within 24 hours after the end of the first dose



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03872830


Contacts
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Contact: Xuedong Gao, MD 0311-66703017 gaoxuedong@yiling.cn

Locations
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China, Hebei
Shijiazhuang Yiling Pharmaceutical Co.,Ltd Not yet recruiting
Shijiazhuang, Hebei, China, 050036
Contact: Xuedong Gao, MD    66703017    gaoxuedong@yiling.cn   
Sponsors and Collaborators
Shijiazhuang Yiling Pharmaceutical Co. Ltd
Investigators
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Principal Investigator: Wen Ouyang, MD The Third Xiangya Hospital of Central South University

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Responsible Party: Shijiazhuang Yiling Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier: NCT03872830     History of Changes
Other Study ID Numbers: BALF-PAIN-2001
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Biphenylylacetic acid
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents