Back to resultsEfficacy, Safety and Tolerability Study of Meloxicam Injection in Subjects After Abdominal Surgery
Primary Purpose
Pain, Post-operative
Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Meloxicam Injection 30mg
Meloxicam Injection 60mg
Nacl 0.9%
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Post-operative
Eligibility Criteria
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.
Sites / Locations
- the Third XiangYa Medical Hospital of Central South University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
meloxicam injection 30 mg
meloxicam injection 60 mg
IV Placebo
Arm Description
meloxicam injection 30mg every 24 hours for up to 2 doses.
meloxicam injection 60mg every 24 hours for up to 2 doses
IV Placebo every 24 hours for up to 2 doses
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Number of Subjects Utilizing Rescue Analgesia
Rescue analgesia (oral oxycodone 5 mg) was available to subjects with inadequately controlled pain upon request.
Full Information
NCT ID
NCT05950152
First Posted
July 10, 2023
Last Updated
July 10, 2023
Sponsor
Beijing Tide Pharmaceutical Co., Ltd
Collaborators
The Third Xiangya Hospital of Central South University
1. Study Identification
Unique Protocol Identification Number
NCT05950152
Brief Title
Efficacy, Safety and Tolerability Study of Meloxicam Injection in Subjects After Abdominal Surgery
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Tide Pharmaceutical Co., Ltd
Collaborators
The Third Xiangya Hospital of Central South University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine the analgesic efficacy and safety of Meloxicam Injection in subjects undergoing abdominal surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Post-operative
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
meloxicam injection 30 mg
Arm Type
Experimental
Arm Description
meloxicam injection 30mg every 24 hours for up to 2 doses.
Arm Title
meloxicam injection 60 mg
Arm Type
Experimental
Arm Description
meloxicam injection 60mg every 24 hours for up to 2 doses
Arm Title
IV Placebo
Arm Type
Placebo Comparator
Arm Description
IV Placebo every 24 hours for up to 2 doses
Intervention Type
Drug
Intervention Name(s)
Meloxicam Injection 30mg
Intervention Description
meloxicam injection 30mg every 24 hours for up to 2 dose
Intervention Type
Drug
Intervention Name(s)
Meloxicam Injection 60mg
Intervention Description
meloxicam injection 60mg every 24 hours for up to 2 dose
Intervention Type
Drug
Intervention Name(s)
Nacl 0.9%
Intervention Description
IV Placebo every 24 hours for up to 2 doses
Primary Outcome Measure Information:
Title
Summed Pain Intensity Difference Over the First 24 Hours (SPID24)
Description
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.
Time Frame
24 Hours
Secondary Outcome Measure Information:
Title
Summed Pain Intensity Difference (SPID) at Other Intervals
Description
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.
Time Frame
48 Hours
Title
Time to First Dose of Rescue Analgesia
Description
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.
Time Frame
48 Hours
Title
Number of Subjects Utilizing Rescue Analgesia
Description
Rescue analgesia (oral oxycodone 5 mg) was available to subjects with inadequately controlled pain upon request.
Time Frame
48 Hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
yangwen ou, medical doctor
Phone
0731-88618151
Email
ouyangwen139@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
saiying wang, medical doctor
Phone
0731-88618150
Email
1771303488@qq.com
Facility Information:
Facility Name
the Third XiangYa Medical Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yangwen ou, medical doctor
Phone
0731-88618151
Email
ouyangwen139@126.com
First Name & Middle Initial & Last Name & Degree
saiying wang, medical doctor
Phone
0731-88618150
Email
1771303488@qq.com
12. IPD Sharing Statement
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Efficacy, Safety and Tolerability Study of Meloxicam Injection in Subjects After Abdominal Surgery
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