Efficacy, Safety and Tolerability Study of Meloxicam Injection in Subjects After Abdominal Surgery
NCT ID: NCT05950152
Last Updated: 2023-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
108 participants
INTERVENTIONAL
2023-07-31
2024-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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meloxicam injection 30 mg
meloxicam injection 30mg every 24 hours for up to 2 doses.
Meloxicam Injection 30mg
meloxicam injection 30mg every 24 hours for up to 2 dose
meloxicam injection 60 mg
meloxicam injection 60mg every 24 hours for up to 2 doses
Meloxicam Injection 60mg
meloxicam injection 60mg every 24 hours for up to 2 dose
IV Placebo
IV Placebo every 24 hours for up to 2 doses
Nacl 0.9%
IV Placebo every 24 hours for up to 2 doses
Interventions
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Meloxicam Injection 30mg
meloxicam injection 30mg every 24 hours for up to 2 dose
Meloxicam Injection 60mg
meloxicam injection 60mg every 24 hours for up to 2 dose
Nacl 0.9%
IV Placebo every 24 hours for up to 2 doses
Eligibility Criteria
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Inclusion Criteria
Be American Society of Anesthesiology (ASA) physical class 1 or 2. Male or female between 18 and 70 years of age, inclusive. Have a body mass index 18\~30 kg/m2. Be able to understand the study procedures, comply with all study procedures, and agree to participate in the study program.
Exclusion Criteria
Have a history of myocardial infarction or coronary artery bypass graft surgery within the preceding 12 months.
Have a history or clinical manifestations of significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, or other condition that would preclude participation in the study.
Have a history of migraine or frequent headaches, seizures, or are currently taking anticonvulsants.
Have another painful physical condition that may confound the assessments of post operative pain.
Have a history of advanced malignant tumor. Have a history of alcohol abuse (regularly drinks \> 4 units of alcohol per day; 8 oz. beer, 3 oz. wine, 1 oz. spirits) within the past 5 years or a history of prescription/illicit drug abuse.
Have positive results on the urine drug screen or alcohol breath test indicative of illicit drug or alcohol abuse.
Have evidence of a clinically significant 12 lead ECG abnormality. Have a clinically significant abnormal clinical laboratory test value. Have history of or positive test results for HIV, treponema pallidum,or hepatitis B or C.
Have a known allergy to meloxicam or any excipient of N1539, D5W, aspirin, other non-steroidal anti-inflammatory drugs (NSAIDs) or to any peri- or postoperative medications used in this study.
Have been receiving or have received chronic opioid therapy defined as greater than 15 morphine equivalents units per day for greater than 3 out of 7 days per week over a one-month period within 12 months of surgery.
18 Years
70 Years
ALL
No
Sponsors
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The Third Xiangya Hospital of Central South University
OTHER
Beijing Tide Pharmaceutical Co., Ltd
INDUSTRY
Responsible Party
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Locations
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the Third XiangYa Medical Hospital of Central South University
Changsha, Hunan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MLI-RD85-P2-2023
Identifier Type: -
Identifier Source: org_study_id
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