Indomethacin SR, 75 Mg Oral Capsule, Extended Release
DrugIndomethacin SR, 75 Mg Oral Capsule, Extended Release orally twice daily
Other names: indomethacin
NCT Number: NCT03582332
2 Non-steroidal anti-inflammatory drugs (NSAIDs), indomethacin and etoricoxib were prescribed sequentially in Axial Spondyloarthritis patients according to the internationally accepted guidelines to determine serum creatinine change with NSAIDs use.
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Notify Me18 year–45 year
All sexes
Interventional
Phase 4
The study had 2 phases. In phase 1, Patients of axial Spondyloarthritis were randomized into 2 groups; group A and group B. they were put on indomethacin 150 mg/day and indomethacin 100 mg/day respectively and were followed up at 3rd week. Those who had normal serum creatinine and responded with the drug were followed up to 24th week. Those who did not respond were excluded from phase 1 and were enrolled in phase 2. Non-responders of indomethacin 150mg and indomethacin 100 mg were put on etoricoxib 90 mg and etoricoxib 60 mg respectively. Again followed up to 24th week.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Indomethacin SR, 75 Mg Oral Capsule, Extended Release orally twice daily
Other names: indomethacin
Indomethacin 25 Mg Oral Capsule, 2 capsule orally twice daily
Other names: indomethacin
Etoricoxib 90 mg once daily orally
Other names: Etoricoxib
Etoricoxib 60 mg once daily orally
Other names: Etoricoxib
Time frame: 3rd week and 24th week
change in serum creatinine >25% from baseline with use of indomethacin and etoricoxib in Axial Spondyloarthritis patients
Time frame: 3rd week and 24th week
<4 responded to treatment, 4 or more means not responded to treatment
Time frame: 3rd week and 24th week
ASDAS: <1.3 between "inactive disease" and "moderate disease activity", <2.1 between "moderate disease activity" and "high disease activity", and >3.5 between "high disease activity" and "very high disease activity"
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Other
Effect of Continuous Administration of Different Therapeutic Dosages of Indomethacin and Etoricoxib in the Management of Axial Spondyloarthritis: A Randomized Controlled Trial
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