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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 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.
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
| Field | Value |
|---|---|
| Enrollment Target | 560 participants |
| Start Date | 2006-11 |
| Est. Completion | 2007-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00396955
The ClinicalTrials.gov registry entry for NCT00396955 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 560 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wyeth is now a wholly owned subsidiary of Pfizer, which has 167 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which PLA-695 is the first listed.
NCT00396955 reports 0 study locations.
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.
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