A Study Comparing The Efficacy And Safety Of Lidocaine 5% Patch With Placebo In Patients With Chronic Axial Low Back Pain

December 5, 2013 updated by: Endo Pharmaceuticals

A Randomized, Double-blind Study Comparing The Efficacy And Safety Of Lidocaine 5% Patch With Placebo In Patients With Chronic Axial Low Back Pain

Patients with Chronic Axial Low Back Pain participated in a Phase II clinical trial to assess the efficacy of lidocaine 5% patch compared with placebo.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
215

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States
    • Arizona
      • Phoenix, Arizona, United States
    • California
      • Carlsbad, California, United States
      • National City, California, United States
    • Connecticut
      • Waterbury, Connecticut, United States
    • District of Columbia
      • Washington, District of Columbia, United States
    • Florida
      • Port Orange, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
    • Illinois
      • Chicago, Illinois, United States
    • Kansas
      • Overland Park, Kansas, United States
    • Massachusetts
      • Pittsfield, Massachusetts, United States
    • North Carolina
      • Burlington, North Carolina, United States
    • Pennsylvania
      • Altoona, Pennsylvania, United States
      • Duncansville, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
    • Tennessee
      • Cordova, Tennessee, United States
    • Texas
      • San Antonio, Texas, United States
    • Virginia
      • Virginia Beach, Virginia, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • Had axial LBP with or without radiation present for at least 3 months as defined as:

    • Chronic axial LBP without radiation: pain isolated to the axial low back without radiation into the buttock or below
    • Chronic axial LBP with radiation: pain that radiates to the buttock or below. This patient group could include patients with radicular/neuropathic and non-radicular components with leg pain component <50%
  • Had daily moderate to severe LBP as the primary source of pain

  • Had a normal neurological examination, including:

    • Motor strength
    • Sensory exam in lower extremities
    • Deep tendon reflexes
  • Had a normal 12-lead electrocardiogram (ECG) without any clinically significant abnormalities in heart rate, rhythm, or conduction
  • Had discontinued use of all analgesic medications (including over-the-counter [OTC] analgesics) prior to randomization (patients were allowed limited use of analgesic medications for indications other than non-study pain).
  • Had a daily average pain intensity rating of 6 or greater (on a 0 to 10 scale) for at least 3 days out of the 5 consecutive days immediately prior to the baseline visit; 0 was defined as "no pain" and 10 was defined as "pain as bad as ever imagined" as measured by Question 5 of the Brief Pain Inventory (BPI) and recorded in a diary

Key Exclusion Criteria:

  • Had spinal stenosis with > 50% leg pain component
  • Had elective surgery scheduled to occur during the 14-week study
  • Had a history of one or more back surgeries within 1 year of study entry
  • Had severe renal insufficiency (creatinine clearance of <30mL/min)
  • Had moderate or greater hepatic impairment
  • Were taking analgesic medications that could not be discontinued during the study. Patients taking these medications prior to the study were required to discontinue use for the duration of the study. Patients using opioid analgesics at study entry were required to taper off these medications.
  • Were taking long-acting opioids or opioids that could not be discontinued over the first 5 days of the placebo run-in period
  • Had received an epidural steroid/local anesthesia injection within 4 weeks prior to study entry
  • Had received trigger point injections within 2 weeks prior to study entry
  • Had received Botulinum Toxin (Botox) Injections for LBP within 6 months prior to study entry
  • Were using a lidocaine-containing product that could not be discontinued during the study
  • Were using any topical medication applied to the low back region
  • Had previously failed treatment with Lidoderm analgesic patch for LBP
  • Were taking class 1 anti-arrhythmic drugs (e.g. mexiletine, tocainide)
  • Had any other chronic pain condition that, in the opinion of the investigator, would have interfered with patient assessment of LBP relief

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Lidocaine 5% Patch
Lidocaine 5% patch (Lidoderm®,Endo Pharmaceuticals Inc.), 2 patches applied directly to the most painful area of the low back once daily (q24h)
Drug: Lidoderm®
Eligible patients were randomly allocated to receive one of two treatments for 12 weeks: lidocaine 5% patch or matching placebo patch.
Other Names:
  • Lidocaine 5% Patch
Placebo Comparator: Placebo Topical Patch
Matching placebo patch, 2 patches applied directly to the most painful area of the low back once daily (q24h)
Drug: Placebo Topical Patch
Eligible patients were randomly allocated to receive one of two treatments for 12 weeks: lidocaine 5% patch or matching placebo patch.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Pain intensity (Question 5 of the BPI)
Time Frame: Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day56), V7/EOS (Day 84)
Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day56), V7/EOS (Day 84)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Safety Assessments included AEs, dermal assessments, clinical laboratory results (including urinalysis), vital sign measurements, physical and neurological examinations, plasma lidocaine concentration
Time Frame: Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day56), V7/EOS (Day 84)
Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day56), V7/EOS (Day 84)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Endo Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2004

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2005

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 15, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 19, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 6, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EN3261-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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