Efficacy, Safety and Tolerability Study of Meloxicam Injection in Subjects After Abdominal Surgery

Tide Pharmaceutical

Status and phase: Not yet enrolling; Phase 2

Conditions: Pain, Post-operative

Treatments: Drug: Meloxicam Injection 60mg; Drug: Nacl 0.9%; Drug: Meloxicam Injection 30mg

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05950152

MLI-RD85-P2-2023

Details and patient eligibility

About

The purpose of this study is to determine the analgesic efficacy and safety of Meloxicam Injection in subjects undergoing abdominal surgery.

Enrollment: 108 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Voluntarily provide written informed consent. Be scheduled to undergo elective abdominoplasty surgery without collateral procedures.

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 abdominoplasty surgery within the preceding 12 months. Have active or recent (within 6 months) gastrointestinal ulceration or bleeding.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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108 participants in 3 patient groups, including a placebo group

meloxicam injection 30 mg

Experimental group

Description:

meloxicam injection 30mg every 24 hours for up to 2 doses.

Treatment:

Drug: Meloxicam Injection 30mg

meloxicam injection 60 mg

Experimental group

Description:

meloxicam injection 60mg every 24 hours for up to 2 doses

Treatment:

Drug: Meloxicam Injection 60mg

IV Placebo

Placebo Comparator group

Description:

IV Placebo every 24 hours for up to 2 doses

Treatment:

Drug: Nacl 0.9%