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

Primary Purpose

Chronic Low Back Pain

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Lidoderm®

About this trial

This is an interventional treatment trial for Chronic Low Back Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Were currently experiencing moderate/severe pain despite current analgesic treatment
Had daily moderate-to-severe LBP for at least 3 months duration
Had a mean daily pain intensity score of >6 on a 0 to 10 scale, with 0 being no pain and 10 being pain as bad as the patients have ever imagined (Question 5 of BPI) during the baseline week; patients had to complete daily diary assessments at least 5 of 7 days during the baseline week

Exclusion Criteria:

Had a history of greater than one back surgery, or one back surgery within 3 months of study entry
Had severe spinal stenosis
Had chronic back pain of >12 months duration with an undefined spinal diagnosis
Had radicular symptoms with radiation into the thigh or below (i.e., knee, calf, foot, etc.)
Had received an epidural steroid/local anesthetic injection within 2 weeks prior to study entry
Had received trigger point injections within 2 weeks prior to study entry
Had received Botulinum Toxin Injections for LBP within 3 months prior to study entry
Were taking a lidocaine-containing product that could not be discontinued while receiving study medication
Were taking class 1 anti-arrhythmic drugs (e.g., mexiletine, tocainide)
Had received Lidoderm for LBP in the past

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1- Lidoderm®

2-Placebo

Arm Description

Lidoderm (lidocaine patch 5%), up to three patches applied topically once daily (q24h) to the area of maximal peripheral pain

Matching placebo, up to three patches applied topically once daily (q24h) to the area of maximal peripheral pain

Outcomes

Primary Outcome Measures

Mean change in average daily pain intensity (BPI Question 5) from baseline week to the final week of treatment (primary endpoint)

Secondary Outcome Measures

Mean change from baseline to Week 2 and Week6/EOS in average daily pain intensity (BPI Question 5)

Pain relief (BPI Question 8)

Mean change from baseline to Week 2 and Week 6 in Pain Quality Assessment Scale (PQAS)

Patient and Investigator Global Impression of Pain Relief at Week 6

QoL: Change from baseline to Week 6 in pain interference with QoL (BPI Question 9) and Profile of Mood States (POMS)

Safety assessments included AEs, discontinuations as a result of AEs, clinical laboratory tests, vital signs, physical examination, plasma lidocaine levels, dermal assessments and sking sensory testing

Full Information

NCT ID

NCT00904475

First Posted

May 15, 2009

Last Updated

February 12, 2010

Sponsor

Endo Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00904475

Brief Title

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

Official Title

A Prospective, Prospective, Double-blind, Randomized, Placebo-Controlled, Pilot Study of the Efficacy and Safety of Lidoderm Patch in the Treatment of Low Back Pain

Study Type

Interventional

2. Study Status

Record Verification Date

February 2010

Overall Recruitment Status

Completed

Study Start Date

April 2003 (undefined)

Primary Completion Date

April 2003 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Endo Pharmaceuticals

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Low Back Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

102 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1- Lidoderm®

Arm Type

Experimental

Arm Description

Lidoderm (lidocaine patch 5%), up to three patches applied topically once daily (q24h) to the area of maximal peripheral pain

Arm Title

2-Placebo

Arm Type

Placebo Comparator

Arm Description

Matching placebo, up to three patches applied topically once daily (q24h) to the area of maximal peripheral pain

Intervention Type

Drug

Intervention Name(s)

Lidoderm®

Other Intervention Name(s)

Lidocaine patch 5%

Intervention Description

Eligible patients were randomized equally to one of two groups: lidocaine patch 5% or matching placebo patch. During the 6-week treatment period, patients used up to three patches daily applied q24h.

Intervention Type

Drug

Intervention Name(s)

Lidoderm®

Other Intervention Name(s)

Lidocaine patch 5%

Intervention Description

Eligible patients were randomized equally to one of two groups: lidocaine patch 5% or matching placebo patch. During the 6-week treatment period, patients used up to three patches daily applied q24h.

Primary Outcome Measure Information:

Title

Mean change in average daily pain intensity (BPI Question 5) from baseline week to the final week of treatment (primary endpoint)

Time Frame

Visit - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 28), V6/EOS (Day 42)

Secondary Outcome Measure Information:

Title

Mean change from baseline to Week 2 and Week6/EOS in average daily pain intensity (BPI Question 5)

Title

Pain relief (BPI Question 8)

Title

Mean change from baseline to Week 2 and Week 6 in Pain Quality Assessment Scale (PQAS)

Title

Patient and Investigator Global Impression of Pain Relief at Week 6

Title

QoL: Change from baseline to Week 6 in pain interference with QoL (BPI Question 9) and Profile of Mood States (POMS)

Title

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Were currently experiencing moderate/severe pain despite current analgesic treatment Had daily moderate-to-severe LBP for at least 3 months duration Had a mean daily pain intensity score of >6 on a 0 to 10 scale, with 0 being no pain and 10 being pain as bad as the patients have ever imagined (Question 5 of BPI) during the baseline week; patients had to complete daily diary assessments at least 5 of 7 days during the baseline week Exclusion Criteria: Had a history of greater than one back surgery, or one back surgery within 3 months of study entry Had severe spinal stenosis Had chronic back pain of >12 months duration with an undefined spinal diagnosis Had radicular symptoms with radiation into the thigh or below (i.e., knee, calf, foot, etc.) Had received an epidural steroid/local anesthetic injection within 2 weeks prior to study entry Had received trigger point injections within 2 weeks prior to study entry Had received Botulinum Toxin Injections for LBP within 3 months prior to study entry Were taking a lidocaine-containing product that could not be discontinued while receiving study medication Were taking class 1 anti-arrhythmic drugs (e.g., mexiletine, tocainide) Had received Lidoderm for LBP in the past

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sr. Director

Organizational Affiliation

Endo Pharmaceuticals

Official's Role

Study Director

Facility Information:

City

Birmingham

State/Province

Alabama

Country

United States

City

Hueytown

State/Province

Alabama

Country

United States

City

Phoenix

State/Province

Arizona

Country

United States

City

Mill Valley

State/Province

California

Country

United States

City

Allentown

State/Province

Pennsylvania

Country

United States

City

Salt Lake City

State/Province

Utah

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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