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Non-Steroidal Anti-inflammatory Drugs in Axial Spondyloarthritis

NCT03473665 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2020-09-22

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Runsheng Wang, MD, MHS · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2019-08-02
Completion
2019-08-02
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03473665 on ClinicalTrials.gov