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NCT00780325 · ClinicalTrials.gov registry record · Phase 1
Effects of Dual Cyclooxygenase-2 and Carbonic Anhydrase Inhibition
A Phase 1 study, sponsored by University of Pennsylvania.
- Terminated
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT00780325: Clinical Trial Phase 1 study, sponsored by University of Pennsylvania.
NCT00780325 is a Phase 1 study that was terminated before completion, run by University of Pennsylvania. The registered enrollment target is 26 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00780325, a Phase 1 study, was terminated before completion, sponsored by University of Pennsylvania.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
Cyclooxygenase-2 (COX-2) inhibitors have become a common analgesic treatment option for patients with arthritis. However, long-term treatment has been associated with increased cardiovascular risk. With the past withdrawals and rejections of approval for COX-2 inhibitors the treatment options are now very limited. This translates for example to about 10 million osteoarthritis patients in the US who cannot receive COX-2 inhibitors because of concomitant hypertension. And this exemplifies the unmet medical need to develop and offer safe treatment options for this particular patient population. This trial investigates pharmacodynamic aspects of CG100649 which is being developed as a novel COX-2 inhibitor. Preclinical data show a dual mechanism of action, which consists of the inhibition of the two enzymes COX-2 and carbonic anhydrase-I/-II (CA-I/II) and through which the cardiovascular risk of COX-2 inhibition might be attenuated.
Interventions
- DRUG Placebo capsules
- DRUG Acetazolamide
- DRUG Celecoxib
- DRUG Naproxen
- DRUG CG100649 (2 mg)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2008-10 |
| Est. Completion | 2013-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00780325
The ClinicalTrials.gov registry entry for NCT00780325 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Placebo capsules is the first listed.
NCT00780325 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00780325 about?
NCT00780325 is a clinical study titled "Effects of Dual Cyclooxygenase-2 and Carbonic Anhydrase Inhibition". Cyclooxygenase-2 (COX-2) inhibitors have become a common analgesic treatment option for patients with arthritis. However, long-term treatment has been associated with increased cardiovascular risk. With the past withdrawals and rejections of approval for COX-2 inhibitors the treatment options are no...
What is the current status of trial NCT00780325?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2008-10. Estimated completion is 2013-07.
What interventions are being tested in trial NCT00780325?
The interventions under investigation include: Placebo capsules (DRUG), Acetazolamide (DRUG), Celecoxib (DRUG), Naproxen (DRUG), CG100649 (2 mg) (DRUG).
Who is sponsoring clinical trial NCT00780325?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
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