The objective of this trial was to assess the efficacy and safety of 15 mg meloxicam i.m. once daily compared with 15 mg meloxicam tablets once daily p.o. in patients with Rheumatoid arthritis over a time period of 7 days.
This was a randomized (1:1), open-label, multi-center, active-control, parallel-group study to compare the efficacy of 15 mg meloxicam i.m. once daily compared with 15 mg meloxicam tablets once daily p.o. in patients with rheumatoid arthritis over a time period of 7 days. Patients eligible for the trial who met all inclusion and exclusion criteria and who gave their informed consent were randomized to one of two treatment groups (i.e. meloxicam ampoule or meloxicam tablet). The study period totaled 8-14 days included screening, randomisation, study drug administration, and 7-day follow-up. The relevant assessment were performed on the day of randomisation and 7-day follow up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
People's Hospital, Beijing University
Beijing, China
Beijing Xuan Wu Hospital
Beijing, China
1st Affiliated, Anhui Medical University
Hefei City, Anhui Province, China
Qilu Hospital, Shang Dong University
Nanzhou, China
Patient's assessment of overall pain
Time frame: 7 days
Patient's global assessment of disease activity
Time frame: 7 days
Investigator's Global Assessment of Disease Activity
Time frame: 7 days
Tender/Painful Joint Count
Time frame: 7 days
Swollen Joint Count
Time frame: 7 days
Duration of Morning Stiffness
Time frame: 7 days
Patient's assessment of physical function
Time frame: 7 days
Final Global Assessment of Efficacy by Patient
Time frame: 7 days
Final Global Assessment of Efficacy by Investigator
Time frame: 7 days
Withdrawals due to Inadequate Efficacy
Time frame: 7 days
Change in Patient Status With Regard to Arthritic Condition as Assessed by the Patient
Time frame: 7 days
Change in Patient Status With Regard to Arthritic Condition as Assessed by the Investigator
Time frame: 7 days
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Shanghai Renji Hospital
Shanghai, China
Shanghai Zhongshan Hospital
Shanghai, China
Shanghai Guanghai Hospital
Shanghai, China
Shanghai Changhai Hospital
Shanghai, China
Onset of Analgesic Action
Time frame: 7 days
Time to Maximum Pain Relief After the First Trial Drug Administration
Time frame: 7 days
Paracetamol Consumption
Time frame: 7 days