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NCT04115098 · ClinicalTrials.gov registry record · Phase 2
Individualizing Anti-Inflammatory Medications for Adults With Axial Spondyloarthritis: A Series of N-of 1 Trials
A Phase 2 study, sponsored by The University of Texas Health Science Center, Houston.
- Terminated
- Registry status
- Phase 2
- Development phase
- 42
- Enrollment target
NCT04115098: Clinical Trial Phase 2 study, sponsored by The University of Texas Health Science Center, Houston.
NCT04115098 is a Phase 2 study that was terminated before completion, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 42 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04115098, a Phase 2 study, was terminated before completion, sponsored by The University of Texas Health Science Center, Houston.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 42 participants
- Enrollment target
Study Summary
The purpose of this study is to compare selective cyclooxygenase-2 (COX-2) and non selective COX inhibitors with respect to the extent to which disease activity is improved without self reported, unacceptable side effects among individual patients with axial spondyloarthritis (AxSpA),to compare selective COX-2 and nonselective COX inhibitors impact on Health related Quality of Life (HrQOL) and how this relates to changes in disease activity and to conduct proteomic assessment of predictive biomarkers of non steroidal anti-inflammatory drug(NSAID) response
Primary Outcome
The ASDAS total score ranges from 0-10, with a higher score meaning worse disease activity. The change in score is reported as \[(ASDAS score at baseline) - (ASDAS score at 4 weeks)\]--a positive value indicates that the score (and disease activity) decreased over time. The "Measure of Dispersion/Precision" indicated as "95% Confidence Interval" actually refers to a "95% Credible Interval."
Interventions
- DRUG Celecoxib
- DRUG Naproxen
- DRUG Meloxicam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2020-06-25 |
| Est. Completion | 2023-08-11 |
| Phase | Phase 2 |
Why NCT04115098 stopped before completion
NCT04115098 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 3 interventions - of which Celecoxib is the first listed.
NCT04115098 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04115098 about?
NCT04115098 is a clinical study titled "Individualizing Anti-Inflammatory Medications for Adults With Axial Spondyloarthritis: A Series of N-of 1 Trials". The purpose of this study is to compare selective cyclooxygenase-2 (COX-2) and non selective COX inhibitors with respect to the extent to which disease activity is improved without self reported, unacceptable side effects among individual patients with axial spondyloarthritis (AxSpA),to compare sele...
What is the current status of trial NCT04115098?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2020-06-25. Estimated completion is 2023-08-11.
What interventions are being tested in trial NCT04115098?
The interventions under investigation include: Celecoxib (DRUG), Naproxen (DRUG), Meloxicam (DRUG).
Who is sponsoring clinical trial NCT04115098?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04115098's enrollment target sits among peer trials
42 1339th of 2000 higher than 649 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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