Trial intelligence / Profile preview

Lidoderm Patch in Chronic Low Back Pain

NCT00904475Phase 4

Key facts

Status: Completed
Start: Apr 2003
Primary completion: Apr 2003
Countries: 1
Sponsor: Endo International plc
Modality: Small Molecules

Drugs: lidocaine 10% oropharyngeal spray
Conditions: chronic low back pain (CLBP)

Overview

Phase 4, randomised, double-blind trial of lidocaine 10% oropharyngeal spray in chronic low back pain (CLBP) (2 arms), sponsored by Endo International plc. Primary endpoint: Mean change in average daily pain intensity (BPI Question 5) at 6 weeks. Started Apr 2003; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Lidoderm
Lidoderm (lidocaine patch 5%)
Placebo
Matching placebo patch

Who it enrols

Patients with moderate to severe chronic low back pain (>3 months) and a daily pain score >6, excluding those with severe spinal stenosis, radicular symptoms below the thigh, or recent back procedures.

Endpoints

Primary

Mean change in average daily pain intensity (BPI Question 5)6 weeks

Secondary

Mean change in average daily pain intensity (BPI Question 5) at Week 22 weeks
Pain relief (BPI Question 8)
Mean change in Pain Quality Assessment Scale (PQAS)6 weeks
Patient and Investigator Global Impression of Pain Relief6 weeks
Change in pain interference with QoL (BPI Question 9)6 weeks
Change in Profile of Mood States (POMS)6 weeks
Adverse Events and Safety Assessments

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