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NCT00521989 · ClinicalTrials.gov registry record · Phase 2
CRx-102 Osteoarthritis Multicenter Evaluation Trial
A Phase 2 study, sponsored by Zalicus.
- Terminated
- Registry status
- Phase 2
- Development phase
- 279
- Enrollment target
NCT00521989: Clinical Trial Phase 2 study, sponsored by Zalicus.
NCT00521989 is a Phase 2 study that was terminated before completion, run by Zalicus. The registered enrollment target is 279 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (110% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00521989, a Phase 2 study, was terminated before completion, sponsored by Zalicus.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 279 participants
- Enrollment target
Study Summary
CRx-102 is a synergistic combination drug candidate containing the cardiovascular drug dipyridamole and a very low dose of the glucocorticoid prednisolone. CRx-102 is believed to work through a novel mechanism of action in which dipyridamole selectively amplifies the anti-inflammatory and immunomodulatory activities of the glucocorticoid without replicating the dose-dependent adverse effects. CRx-102 has been associated with clinical benefit in proof of concept studies in subjects with hand OA and RA. This is the first study to explore the efficacy of CRx-102 in knee OA. It is considered a dose-finding study and will also compare the potential benefits of CRx-102 treatment to both prednisolone administered alone and to placebo in this indication.
Primary Outcome
The WOMAC Index is a validated, 24-question self-administered assessment of three dimensions of pain, stiffness, and physical function for subjects with knee or hip OA. The WOMAC pain question #1 asks subjects to "think about the pain you felt in your (study joint) caused by your arthritis during the last 48 hours when walking on a flat surface." This is a visual analog scale (VAS) where the subject indicates pain severity by making a mark through a 100 mm horizontal line with "No Pain" on the l
Interventions
- DRUG Placebo
- DRUG Prednisolone
- DRUG CRx-102 (2.7/180)
- DRUG CRx-102 (2.7/360)
- DRUG CRx-102 (2.7/90)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 279 participants |
| Start Date | 2007-08 |
| Est. Completion | 2009-07 |
| Phase | Phase 2 |
Why NCT00521989 stopped before completion
NCT00521989 is an interventional study that assigns participants to a tested intervention. The registered 279 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (110% higher).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT00521989 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00521989 about?
NCT00521989 is a clinical study titled "CRx-102 Osteoarthritis Multicenter Evaluation Trial". CRx-102 is a synergistic combination drug candidate containing the cardiovascular drug dipyridamole and a very low dose of the glucocorticoid prednisolone. CRx-102 is believed to work through a novel mechanism of action in which dipyridamole selectively amplifies the anti-inflammatory and immunomodu...
What is the current status of trial NCT00521989?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 279 participants. The study started on 2007-08. Estimated completion is 2009-07.
What interventions are being tested in trial NCT00521989?
The interventions under investigation include: Placebo (DRUG), Prednisolone (DRUG), CRx-102 (2.7/180) (DRUG), CRx-102 (2.7/360) (DRUG), CRx-102 (2.7/90) (DRUG).
Who is sponsoring clinical trial NCT00521989?
This trial is sponsored by Zalicus, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00521989's enrollment target sits among peer trials
279 201st of 2000 higher than 1,799 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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