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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 . |
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| 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 . |
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| 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 . |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the pain intensity curve(AUC) | Pain intensity under exercise/rest state - area under the time curve | up to 24 hours after multi-dose |
| Press time | The first time to press the analgesic pump for analgesia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wen Ouyang, MD | The Third Xiangya Hospital of Central South University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shijiazhuang Yiling Pharmaceutical Co.,Ltd | Shijiazhuang | Hebei | 050036 | China |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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. |
|
| 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 | 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 | up to 24 hours after multi-dose |