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UNKNOWNPHASE2

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

A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Analgesic Efficacy, Safety and Tolerability of Meloxicam Injection in Subjects After Abdominal Surgery

NCT05950152•Beijing Tide Pharmaceutical Co., Ltd

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 70 years

Sex

ALL

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.

Locations (1)

the Third XiangYa Medical Hospital of Central South University

Changsha, Hunan, China

Key Dates

Start Date

July 1, 2023

Primary Completion Date

December 1, 2023

Completion Date

February 1, 2024

Last Updated

July 18, 2023

Enrollment

108

ESTIMATED participants

Conditions

Pain, Post-operative

Interventions

Meloxicam Injection 30mg

DRUG

Meloxicam Injection 60mg

DRUG

Nacl 0.9%

DRUG

Contacts

yangwen ou, medical doctor

CONTACT

0731-88618151 ouyangwen139@126.com

saiying wang, medical doctor

CONTACT

0731-88618150 1771303488@qq.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 18, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Controlled Trial to Determine Most Effective Post-Operative Analgesia After Third Molar Extraction

Evaluation of N1539 Following Abdominoplasty Surgery

Placebo-Controlled Evaluation of Intranasal Dexmedetomidine for Postoperative Analgesia Following Bunionectomy Surgery