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NCT00904397 · ClinicalTrials.gov registry record · Phase 4

Lidocaine Patch 5% Versus Celecoxib 200 mg in Chronic Axial Low Back Pain

A Phase 4 study, sponsored by Endo USA Inc., a Keenova Therapeutics Company.

Terminated
Registry status
Phase 4
Development phase
98
Enrollment target

NCT00904397: Clinical Trial Phase 4 study, sponsored by Endo USA Inc., a Keenova Therapeutics Company.

NCT00904397 is a Phase 4 study that was terminated before completion, run by Endo USA Inc., a Keenova Therapeutics Company. The registered enrollment target is 98 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00904397, a Phase 4 study, was terminated before completion, sponsored by Endo USA Inc., a Keenova Therapeutics Company.

TERMINATED
Registry status
Phase 4
Development phase
98 participants
Enrollment target

Study Summary

Patients who had axial lower back pain (LBP) with or without radiation present for at least 3 months and had daily moderate to severe LBP as the primary source of pain participated in a Phase IV clinical trial to assess the efficacy of lidocaine patch 5% compared to celecoxib 200 mg in treating chronic axial LBP with and without radiation.

Interventions

  • DRUG Celecoxib
  • DRUG Lidoderm®

Trial Details

FieldValue
Enrollment Target 98 participants
Start Date 2004-07
Phase Phase 4

Why NCT00904397 stopped before completion

NCT00904397 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower).

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

NCT00904397 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00904397 about?

NCT00904397 is a clinical study titled "Lidocaine Patch 5% Versus Celecoxib 200 mg in Chronic Axial Low Back Pain". Patients who had axial lower back pain (LBP) with or without radiation present for at least 3 months and had daily moderate to severe LBP as the primary source of pain participated in a Phase IV clinical trial to assess the efficacy of lidocaine patch 5% compared to celecoxib 200 mg in treating chro...

What is the current status of trial NCT00904397?

This trial is currently terminated. It is a Phase 4 study. The enrollment target is 98 participants. The study started on 2004-07.

What interventions are being tested in trial NCT00904397?

The interventions under investigation include: Celecoxib (DRUG), Lidoderm® (DRUG).

Who is sponsoring clinical trial NCT00904397?

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 NCT00904397's enrollment target sits among peer trials

98 854th of 2000 higher than 1,140 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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 NCT00904397, the US trial registry maintained by the National Library of Medicine. NCT00904397 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.