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Report for Clinical Trial NCT03473665

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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.

NCT03473665 Ankylosing Spondylitis Axial Spondyloarthritis
MeSH:Spondylitis Spondylitis, Ankylosing Spondylarthritis

4 Interventions

Name: Indomethacin

Description: Indomethacin Extended Release Oral Tablet 75mg every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks
Type: Drug
Group Labels: 1

Indomethacin

Name: Diclofenac

Description: Diclofenac Delayed Release Oral Tablet 25mg tablets x 3 tablets every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks
Type: Drug
Group Labels: 1

Diclofenac

Name: Meloxicam

Description: meloxicam 7.5mg tablets every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks
Type: Drug
Group Labels: 1

Meloxicam

Name: Celecoxib

Description: Celecoxib 200mg capsule every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks
Type: Drug
Group Labels: 1

Celecoxib


Primary Outcomes

Description: Change of pain score by numerical rating score from baseline [scale range: 0 (better) -10 (worse)]

Measure: Change of pain score

Time: Week 4 and Week 6

Secondary Outcomes

Description: Change of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) from baseline [scale range: 0 (better) -10 (worse)]

Measure: Change of BASDAI

Time: Week 4 and Week 6

Description: Change of Bath Ankylosing Spondylitis Functional Index (BASFI) from baseline [scale range: 0 (better) -10 (worse)]

Measure: change of BASFI

Time: Week 4 and Week 6

Description: Change of Ankylosing Spondylitis Disease Activity Score (ASDAS) from baseline [composite score: 0 (no disease activity) - 6.5 (very high disease activity)]

Measure: Change of ASDAS

Time: Week 4 and Week 6

Description: Patient's global assessment of effectiveness of a treatment

Measure: Patient Global Assessment of Response to Therapy (PGART)

Time: Week 6

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 Q12H

Ankylosing Spondylitis Axial Spondyloarthritis Spondylitis Spondylitis, Ankylosing Spondylarthritis 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 Q12H; 2) diclofenac 75mg Q12H; 3) meloxicam 7.5mg Q12H; 4) celecoxib 200mg Q12H. --- Q12H ---

Ankylosing Spondylitis Axial Spondyloarthritis Spondylitis Spondylitis, Ankylosing Spondylarthritis 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 Q12H; 2) diclofenac 75mg Q12H; 3) meloxicam 7.5mg Q12H; 4) celecoxib 200mg Q12H. --- Q12H --- --- Q12H ---

Ankylosing Spondylitis Axial Spondyloarthritis Spondylitis Spondylitis, Ankylosing Spondylarthritis 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 Q12H; 2) diclofenac 75mg Q12H; 3) meloxicam 7.5mg Q12H; 4) celecoxib 200mg Q12H. --- Q12H --- --- Q12H --- --- Q12H ---

Ankylosing Spondylitis Axial Spondyloarthritis Spondylitis Spondylitis, Ankylosing Spondylarthritis 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 Q12H; 2) diclofenac 75mg Q12H; 3) meloxicam 7.5mg Q12H; 4) celecoxib 200mg Q12H. --- Q12H --- --- Q12H --- --- Q12H --- --- Q12H ---



HPO Nodes