Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00346216 · ClinicalTrials.gov registry record · Phase 4
Prospective Randomized Evaluation Of Celecoxib Integrated Safety Vs Ibuprofen Or Naproxen
A Phase 4 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- Completed
- Registry status
- Phase 4
- Development phase
- 24,081
- Enrollment target
NCT00346216: Completed Phase 4 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
NCT00346216 is a Phase 4 study that has completed, run by Pfizer's Upjohn has merged with Mylan to form Viatris. The registered enrollment target is 24,081 participants, above the 516-participant average among 9,235 other Phase 4 trials with a reported enrollment target (4567% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00346216, a Phase 4 study, has completed, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 24,081 participants
- Enrollment target
Study Summary
To answer the question of overall benefit: risk of celecoxib when compared to two most commonly prescribe traditional (non-selective) nonsteroidal anti-inflammatory drugs (NSAIDs) in the treatment of arthritis pain. For this purpose, patients with osteoarthritis or rheumatoid arthritis with or at risk of developing cardiovascular disease will be recruited. The cardiovascular, gastrointestinal and renal safety and symptomatic benefit in each treatment group will be assessed accordingly.
Primary Outcome
APTC events are defined as a composite of any of the following events: Death due to CV causes (including cardiac, cerebrovascular, venous thromboembolic, haemorrhagic, other vascular, or unknown cause); Non-fatal MI; Non-fatal stroke (including intracranial hemorrhages, stroke of ischemic or unknown etiology).
Interventions
- DRUG Ibuprofen
- DRUG Naproxen
- DRUG celecoxib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24,081 participants |
| Start Date | 2006-10-04 |
| Est. Completion | 2016-04-12 |
| Phase | Phase 4 |
What the finished NCT00346216 record still lists
NCT00346216 is an interventional study that assigns participants to a tested intervention. Its 24,081 participants enrollment target places it among the larger protocols in the corpus, above the 516-participant average among 9,235 other Phase 4 trials with a reported enrollment target (4567% higher).
The record links to 0 conditions, and to 3 interventions - of which Ibuprofen is the first listed.
NCT00346216 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00346216 about?
NCT00346216 is a clinical study titled "Prospective Randomized Evaluation Of Celecoxib Integrated Safety Vs Ibuprofen Or Naproxen". To answer the question of overall benefit: risk of celecoxib when compared to two most commonly prescribe traditional (non-selective) nonsteroidal anti-inflammatory drugs (NSAIDs) in the treatment of arthritis pain. For this purpose, patients with osteoarthritis or rheumatoid arthritis with or at ri...
What is the current status of trial NCT00346216?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 24,081 participants. The study started on 2006-10-04. Estimated completion is 2016-04-12.
What interventions are being tested in trial NCT00346216?
The interventions under investigation include: Ibuprofen (DRUG), Naproxen (DRUG), celecoxib (DRUG).
Who is sponsoring clinical trial NCT00346216?
This trial is sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris, which has 158 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00346216's enrollment target sits among peer trials
24,081 5th of 2000 higher than 1,996 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06995898 · 24,000 participants · NA
The Vanguard Study: Testing a New Way to Screen for Cancer
- NCT04595201 · 25,000 participants
Clinical Follow-up of Pregnant Subjects Undergoing NIPT
- NCT04994015 · 25,000 participants
Parkinson's Foundation PD GENEration Genetic Registry
- NCT06589310 · 25,000 participants
Falcon Real World Evidence Registry
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI