NCT00904475

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for phase_4

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2003

Completed
6.1 years until next milestone

First Submitted

Initial submission to the registry

May 15, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 19, 2009

Completed
Last Updated

February 15, 2010

Status Verified

February 1, 2010

Enrollment Period

Same day

First QC Date

May 15, 2009

Last Update Submit

February 12, 2010

Conditions

Chronic Low Back Pain

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (6)

  • 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)

  • +1 more secondary outcomes

Study Arms (2)

1- Lidoderm®

EXPERIMENTAL

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

Drug: Lidoderm®

2-Placebo

PLACEBO COMPARATOR

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

Drug: Lidoderm®

Interventions

Lidoderm®DRUG

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.

Also known as: Lidocaine patch 5%
1- Lidoderm®

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Unknown Facility

Birmingham, Alabama, United States

Location

Unknown Facility

Hueytown, Alabama, United States

Location

Unknown Facility

Phoenix, Arizona, United States

Location

Unknown Facility

Mill Valley, California, United States

Location

Unknown Facility

Allentown, Pennsylvania, United States

Location

Unknown Facility

Salt Lake City, Utah, United States

Location

MeSH Terms

Interventions

Lidoderm

Study Officials

  • Sr. Director

    Endo Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 15, 2009

First Posted

May 19, 2009

Study Start

April 1, 2003

Primary Completion

April 1, 2003

Last Updated

February 15, 2010

Record last verified: 2010-02

Locations

US(6)