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NCT00396955 · ClinicalTrials.gov registry record · Phase 2

A Study Comparing 4 Dose Regimens of PLA-695, Naproxen, and Placebo In Subjects With Osteoarthritis Of The Knee

A Phase 2 study, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.

Terminated
Registry status
Phase 2
Development phase
560
Enrollment target

NCT00396955: Clinical Trial Phase 2 study, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.

NCT00396955 is a Phase 2 study that was terminated before completion, run by Wyeth is now a wholly owned subsidiary of Pfizer. The registered enrollment target is 560 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (321% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00396955, a Phase 2 study, was terminated before completion, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.

TERMINATED
Registry status
Phase 2
Development phase
560 participants
Enrollment target

Study Summary

Objectives: Primary:To assess the efficacy and safety of PLA-695 in subjects with active osteoarthritis (OA) of the knee. Secondary:To determine the pharmacokinetics (PK) and pharmacodynamics (PD) of PLA-695 among dose levels. To assess health outcome measures. To assess the effect of PLA-695 on biomarkers related to clinical responses. To assess PLA-695 exposure-response relationship on PD, efficacy, and safety measures. To assess pharmacogenomics (PGX) analysis in OA.

Interventions

  • DRUG PLA-695

Trial Details

FieldValue
Enrollment Target 560 participants
Start Date 2006-11
Est. Completion 2007-11
Phase Phase 2

Why NCT00396955 stopped before completion

NCT00396955 is an interventional study that assigns participants to a tested intervention. The registered 560 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 (321% higher).

The record links to 0 conditions, and to 1 intervention - of which PLA-695 is the first listed.

NCT00396955 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00396955 about?

NCT00396955 is a clinical study titled "A Study Comparing 4 Dose Regimens of PLA-695, Naproxen, and Placebo In Subjects With Osteoarthritis Of The Knee". Objectives: Primary:To assess the efficacy and safety of PLA-695 in subjects with active osteoarthritis (OA) of the knee. Secondary:To determine the pharmacokinetics (PK) and pharmacodynamics (PD) of PLA-695 among dose levels. To assess health outcome measures. To assess the effect of PLA-695 on bi...

What is the current status of trial NCT00396955?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 560 participants. The study started on 2006-11. Estimated completion is 2007-11.

What interventions are being tested in trial NCT00396955?

The interventions under investigation include: PLA-695 (DRUG).

Who is sponsoring clinical trial NCT00396955?

This trial is sponsored by Wyeth is now a wholly owned subsidiary of Pfizer, which has 167 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00396955's enrollment target sits among peer trials

560 60th of 2000 higher than 1,941 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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Source: ClinicalTrials.gov NCT00396955, the US trial registry maintained by the National Library of Medicine. NCT00396955 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.