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NCT00504127 · ClinicalTrials.gov registry record · Phase 3

Efficacy and Safety Study of Naproxcinod in Subjects With Osteoarthritis of the Knee

A Phase 3 study, sponsored by NicOx.

Completed
Registry status
Phase 3
Development phase
1,020
Enrollment target

NCT00504127: Completed Phase 3 study, sponsored by NicOx.

NCT00504127 is a Phase 3 study that has completed, run by NicOx. The registered enrollment target is 1,020 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (32% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00504127, a Phase 3 study, has completed, sponsored by NicOx.

COMPLETED
Registry status
Phase 3
Development phase
1,020 participants
Enrollment target

Study Summary

To study of efficacy and safety of Naproxcinod vs. Naproxen and Placebo in the indication of signs and symptoms of osteoarthritis

Interventions

  • DRUG placebo
  • DRUG Naproxcinod 375 mg bid
  • DRUG Naproxcinod 750 mg bid
  • DRUG Naproxen 500 mg bid

Trial Details

FieldValue
Enrollment Target 1,020 participants
Start Date 2007-04
Phase Phase 3
NicOx

6 total trials

What the finished NCT00504127 record still lists

NCT00504127 is an interventional study that assigns participants to a tested intervention. Its 1,020 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (32% higher).

The record links to 0 conditions, and to 4 interventions - of which placebo is the first listed.

NCT00504127 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00504127 about?

NCT00504127 is a clinical study titled "Efficacy and Safety Study of Naproxcinod in Subjects With Osteoarthritis of the Knee". To study of efficacy and safety of Naproxcinod vs. Naproxen and Placebo in the indication of signs and symptoms of osteoarthritis

What is the current status of trial NCT00504127?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,020 participants. The study started on 2007-04.

What interventions are being tested in trial NCT00504127?

The interventions under investigation include: placebo (DRUG), Naproxcinod 375 mg bid (DRUG), Naproxcinod 750 mg bid (DRUG), Naproxen 500 mg bid (DRUG).

Who is sponsoring clinical trial NCT00504127?

This trial is sponsored by NicOx, which has 6 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00504127's enrollment target sits among peer trials

1,020 291st of 2000 higher than 1,708 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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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Source: ClinicalTrials.gov NCT00504127, the US trial registry maintained by the National Library of Medicine. NCT00504127 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.