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

NCT05950152 | Unknown Phase 2

• 1 other identifier: MLI-RD85-P2-2023
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain, Post-operative

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Summed Pain Intensity Difference (SPID) at Other Intervals

  48 Hours

• Time to First Dose of Rescue Analgesia

  48 Hours

• Number of Subjects Utilizing Rescue Analgesia

  48 Hours

Study Arms (3)

meloxicam injection 30 mg

EXPERIMENTAL

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

Drug: Meloxicam Injection 30mg

meloxicam injection 60 mg

EXPERIMENTAL

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

Drug: Meloxicam Injection 60mg

IV Placebo

PLACEBO COMPARATOR

IV Placebo every 24 hours for up to 2 doses

Drug: Nacl 0.9%

Interventions

Meloxicam Injection 30mg DRUG

meloxicam injection 30mg every 24 hours for up to 2 dose

meloxicam injection 30 mg

Meloxicam Injection 60mg DRUG

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

meloxicam injection 60 mg

Nacl 0.9% DRUG

IV Placebo every 24 hours for up to 2 doses

IV Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tide Pharmaceutical Co., Ltd: lead
• The Third Xiangya Hospital of Central South University: collaborator

Study Sites (1)

the Third XiangYa Medical Hospital of Central South University

Changsha, Hunan, 410013, China

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Meloxicam; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiazines; Sulfur Compounds; Organic Chemicals; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

yangwen ou, medical doctor

CONTACT

0731-88618151; ouyangwen139@126.com

saiying wang, medical doctor

CONTACT

0731-88618150; 1771303488@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: July 18, 2023
• Study Start: July 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: February 1, 2024
• Last Updated: July 18, 2023

Record last verified: 2023-07

Locations

CN (1)