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NCT00589979 · ClinicalTrials.gov registry record · Phase 2

Efficacy and Safety of the Lidoderm Patch Applied to Patients With Osteoarthritis of the Knee

A Phase 2 study, sponsored by Endo USA Inc., a Keenova Therapeutics Company.

Completed
Registry status
Phase 2
Development phase
169
Enrollment target

NCT00589979: Completed Phase 2 study, sponsored by Endo USA Inc., a Keenova Therapeutics Company.

NCT00589979 is a Phase 2 study that has completed, run by Endo USA Inc., a Keenova Therapeutics Company. The registered enrollment target is 169 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (27% higher). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT00589979, a Phase 2 study, has completed, sponsored by Endo USA Inc., a Keenova Therapeutics Company.

COMPLETED
Registry status
Phase 2
Development phase
169 participants
Enrollment target

Study Summary

Patients with knee pain due to Osteoarthritis (OA) experiencing sub-optimal pain relief from their current analgesic regimen will participate in a pilot clinical trial to evaluate the effectiveness and tolerability of the Lidoderm Patch compared with placebo in treating knee pain from OA.

Primary Outcome

Time-to-exit was defined as the number of days at which a patient either met the switching criterion \[a 2-category change in the Pain Relief Scale (PRS) score in the worsening direction (increasing pain or decreasing pain relief) for 2 consecutive days\] or discontinued from the study. The PRS is a 9-point categorical rating scale to assess pain relief in the last 24 hours in which 0 = completely worse and 8 = complete pain relief. Traditional survival models that consider event times (e.g. med

Interventions

  • DRUG Placebo Patch
  • DRUG Lidoderm (Lidocaine 5% Patch)

Trial Details

FieldValue
Enrollment Target 169 participants
Start Date 2007-03
Est. Completion 2008-10
Phase Phase 2

What the finished NCT00589979 record still lists

NCT00589979 is an interventional study that assigns participants to a tested intervention. The registered 169 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 (27% higher).

The record links to 0 conditions, and to 2 interventions - of which Placebo Patch is the first listed.

NCT00589979 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00589979 about?

NCT00589979 is a clinical study titled "Efficacy and Safety of the Lidoderm Patch Applied to Patients With Osteoarthritis of the Knee". Patients with knee pain due to Osteoarthritis (OA) experiencing sub-optimal pain relief from their current analgesic regimen will participate in a pilot clinical trial to evaluate the effectiveness and tolerability of the Lidoderm Patch compared with placebo in treating knee pain from OA.

What is the current status of trial NCT00589979?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 169 participants. The study started on 2007-03. Estimated completion is 2008-10.

What interventions are being tested in trial NCT00589979?

The interventions under investigation include: Placebo Patch (DRUG), Lidoderm (Lidocaine 5% Patch) (DRUG).

Who is sponsoring clinical trial NCT00589979?

This trial is sponsored by Endo USA Inc., a Keenova Therapeutics Company, which has 61 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00589979's enrollment target sits among peer trials

169 403rd of 2000 higher than 1,598 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 NCT00589979, the US trial registry maintained by the National Library of Medicine. NCT00589979 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.