NCT03473665

Non-Steroidal Anti-inflammatory Drugs in Axial Spondyloarthritis

Non-Steroidal Anti-inflammatory Drugs in Axial Spondyloarthritis: a Pilot Study

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a 6-week randomized, double-blind trial of 4 different non-steroidal anti-inflammatory drugs in patients with axial spondyloarthritis to compare the change of pain score from baseline at 4 weeks to the change of pain score from baseline at 6 weeks.

Detailed description

Patients with ankylosing spondylitis or axial spondyloarthritis who fulfills the inclusion and exclusion criteria will be randomized into one of the four arms after an initial one week washout period, including: 1) indomethacin 75mg every 12 hours (Q12H); 2) diclofenac 75mg Q12H; 3) meloxicam 7.5mg Q12H; 4) celecoxib 200mg Q12H. The treatment length will be 6 weeks. Primary outcome is the change of pain score from baseline to week 4 and to week 6.

Conditions

• Ankylosing Spondylitis
• Axial Spondyloarthritis

Interventions

Type	Name	Description
DRUG	Indomethacin	Indomethacin Extended Release Oral Tablet 75mg every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks
DRUG	Diclofenac	Diclofenac Delayed Release Oral Tablet 25mg tablets x 3 tablets every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks
DRUG	Meloxicam	meloxicam 7.5mg tablets every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks
DRUG	Celecoxib	Celecoxib 200mg capsule every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks

Timeline

• Start date: 2018-03-01
• Primary completion: 2019-08-02
• Completion: 2019-08-02
• First posted: 2018-03-22
• Last updated: 2020-09-22
• Results posted: 2020-09-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study