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

Pain, Post-operative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05950152
• Other study ID #: MLI-RD85-P2-2023
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 2023
• Est. completion date: February 2024

Study information

• Verified date: July 2023
• Source: Beijing Tide Pharmaceutical Co., Ltd
• Contact: yangwen ou, medical doctor
• Phone: 0731-88618151
• Email: ouyangwen139[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 108
• Est. completion date: February 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Post-operative
• Pain, Postoperative

Intervention

Drug:
• 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

Locations

Country	Name	City	State
China	the Third XiangYa Medical Hospital of Central South University	Changsha	Hunan

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Tide Pharmaceutical Co., Ltd	The Third Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Summed Pain Intensity Difference Over the First 24 Hours (SPID24)	Pain intensity was recorded using a Numeric Pain Rating Scale (Range 0-10) where 0 equates to no pain (better), and 10 equates to the worst pain imaginable (worse). Pain intensity scores were to be recorded at the following time points: 0.25, 0.5, 0.75, 1, and 2 hours post Dose 1. Thereafter pain assessments were to be recorded every 2 hours until 48 hours post Dose 1. Pain intensity differences from baseline at each time point were calculated and a time weighted summed pain intensity difference (SPID) was then calculated. Time weighted SPID calculations were computed by multiplying a weight factor to each score prior to summation. The weight factor at each time point was the time elapsed since the previous observation. A smaller SPID value (i.e. more negative) was better.	24 Hours
Secondary	Summed Pain Intensity Difference (SPID) at Other Intervals	Pain intensity was recorded using a Numeric Pain Rating Scale (Range 0-10) where 0 equates to no pain (better), and 10 equates to the worst pain imaginable (worse). Pain intensity scores were to be recorded at the following time points: 0.25, 0.5, 0.75, 1, and 2 hours post Dose 1. Thereafter pain assessments were to be recorded every 2 hours until 48 hours post Dose 1. Pain intensity differences from baseline at each time point were calculated and a time weighted summed pain intensity difference (SPID) was then calculated. Time weighted SPID calculations were computed by multiplying a weight factor to each score prior to summation. The weight factor at each time point was the time elapsed since the previous observation. A smaller SPID value (i.e. more negative) was better.	48 Hours
Secondary	Time to First Dose of Rescue Analgesia	Rescue analgesia (oral oxycodone 5 mg) was available to subjects with inadequately controlled pain upon request. Time to first rescue was calculated as the elapsed time from administration of Dose 1 to the administration of the first dose of rescue analgesia.	48 Hours
Secondary	Number of Subjects Utilizing Rescue Analgesia	Rescue analgesia (oral oxycodone 5 mg) was available to subjects with inadequately controlled pain upon request.	48 Hours