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COMPLETED Phase 4

Pilot Study of the Efficacy and Safety of Lidoderm Patch in the Treatment of Low Back Pain

NCT00904475 · View on ClinicalTrials.gov ↗

Study Summary

Patients with moderate to severe chronic Low Back Pain (LBP) despite current analgesic treatment participated in a Phase IV clinical trial to evaluate the analgesic efficacy of the lidocaine patch 5% compared to placebo in treating moderate to severe chronic LBP.

Conditions Studied

Interventions

  • DRUG Lidoderm®

Study Locations (6)

Alabama

  • — Birmingham
  • — Hueytown

Arizona

  • — Phoenix

California

  • — Mill Valley

Pennsylvania

  • — Allentown

Utah

  • — Salt Lake City

Trial Details

FieldValue
Enrollment Target 102 participants
Start Date 2003-04
Phase Phase 4

Sponsor

Endo Pharmaceuticals

23 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00904475

The ClinicalTrials.gov registry entry for NCT00904475 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 102 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Endo Pharmaceuticals, which has 23 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Chronic Low Back Pain appearing as the primary indexed condition, and to 1 intervention — of which Lidoderm® is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00904475 reports 6 study locations spanning 5 distinct geographic areas — top geographies include Alabama, Arizona, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00904475 about?

NCT00904475 is a clinical study titled "Pilot Study of the Efficacy and Safety of Lidoderm Patch in the Treatment of Low Back Pain". Patients with moderate to severe chronic Low Back Pain (LBP) despite current analgesic treatment participated in a Phase IV clinical trial to evaluate the analgesic efficacy of the lidocaine patch 5% compared to placebo in treating moderate to severe chronic LBP.

What is the current status of trial NCT00904475?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 102 participants. The study started on 2003-04.

What conditions does trial NCT00904475 study?

This clinical trial studies the following conditions: Chronic Low Back Pain. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00904475?

The interventions under investigation include: Lidoderm® (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00904475?

This trial is sponsored by Endo Pharmaceuticals, which has 23 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00904475 being conducted?

This trial has 6 study locations across Alabama, Arizona, California, Pennsylvania, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial