NCT03582332

Serum Creatinine Change / Renal Adverse Effect With Use of Non-steroidal Painkillers in Axial Spondyloarthritis Patients

Effect of Continuous Administration of Different Therapeutic Dosages of Indomethacin and Etoricoxib in the Management of Axial Spondyloarthritis: A Randomized Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Axial Spondyloarthritis

Interventions

Type	Name	Description
DRUG	Indomethacin SR, 75 Mg Oral Capsule, Extended Release	Indomethacin SR, 75 Mg Oral Capsule, Extended Release orally twice daily
DRUG	Indomethacin 25 Mg Oral Capsule	Indomethacin 25 Mg Oral Capsule, 2 capsule orally twice daily
DRUG	Etoricoxib 90 mg	Etoricoxib 90 mg once daily orally
DRUG	Etoricoxib 60 mg	Etoricoxib 60 mg once daily orally

Timeline

• Start date: 2016-01-02
• Primary completion: 2016-06-23
• Completion: 2016-06-23
• First posted: 2018-07-11
• Last updated: 2018-07-11