NCT02749123

Brief Summary

A comparison of transdermal patches for efficacy, side effects and quality of life for patients with back pain and arthritis. The three arms in the trial were; prescription strength lidocaine 5%, over the counter lidocaine 3.6%, menthol 1.25% and placebo.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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, 2016

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

April 18, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 22, 2016

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

April 22, 2016

Status Verified

April 1, 2016

Enrollment Period

1 month

First QC Date

April 18, 2016

Last Update Submit

April 19, 2016

Conditions

Back PainArthritis

Outcome Measures

Primary Outcomes (1)

  • Efficacy comparison of lidocaine 5% and lidocaine 3.6%, menthol 1.25% as measured by VAS numeric 0-10 pain scale

    Endpoint is a non-inferiority statistical comparison. Comparison is based off of analysis of identical questionnaires administered at baseline and day ten

    Day ten

Secondary Outcomes (4)

  • Quality of life comparison of placebo and lidocaine 3.6%, menthol 1.25% as measured by VAS numeric 0-10 pain scale

    Day ten

  • Efficacy comparison of placebo and lidocaine 3.6%, menthol 1.25% as measured by VAS numeric 0-10 pain scale

    Day 10

  • Side effect comparison of placebo and lidocaine 3.6%, menthol 1.25% as measured by VAS numeric 0-10 pain scale

    Day 10

  • Side effect comparison of lidocaine 5% and lidocaine 3.6%, menthol 1.25% as measured by VAS numeric 0-10 pain scale

    Day 10

Study Arms (2)

Lidocaine5% v Lidocaine3.6%,Menthol1.25%

ACTIVE COMPARATOR

Daily patch Q12 followed by Q12 of no patch

Drug: lidocaine 5% patchDrug: lidocaine 3.6%, menthol 1.25%

Lidocaine 3.6%, menthol 1.25% v placebo

PLACEBO COMPARATOR

Daily patch Q12 followed by Q12 of no patch

Drug: lidocaine 3.6%, menthol 1.25%Drug: Placebo

Interventions

lidocaine 5% patchDRUG

10cmx 14 cm transdermal patch sealed in its own pouch

Also known as: Lidoderm
Lidocaine5% v Lidocaine3.6%,Menthol1.25%
lidocaine 3.6%, menthol 1.25%DRUG

10cmx 14 cm transdermal patch sealed in its own pouch

Also known as: LidoPatch
Lidocaine 3.6%, menthol 1.25% v placeboLidocaine5% v Lidocaine3.6%,Menthol1.25%
PlaceboDRUG

patch with no active manufactured to have the same look and feel as Lidoderm 10cmx 14 cm transdermal patch sealed in its own pouch

Lidocaine 3.6%, menthol 1.25% v placebo

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of back pain
  • Diagnosis of arthritis

You may not qualify if:

  • Pregnancy or expected pregnancy in the next three months
  • Allergic to any lidocaine, menthol and methylparaben
  • No reliable access to the internet
  • Baseline average pain intensity of 1,2,9 or 10 on a scale of 0-to 10.
  • Pain on the area of the body not conducive to patch therapy (eg fingers, toes etc)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Advocate Good Sheppard Hospital

Barrington, Illinois, 60010, United States

RECRUITING

MeSH Terms

Conditions

Back PainArthritis

Interventions

LidocaineTransdermal PatchLidoderm

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsJoint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesEquipment and Supplies

Central Study Contacts

James J Ciullo, MBA

CONTACT

6302512873jay@lidopatch.com

Eric Castro, MD

CONTACT

773-771-4160jedc269@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2016

First Posted

April 22, 2016

Study Start

April 1, 2016

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

April 22, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Investigators plan to share the study results as a whole but no plans to share individual results.

Locations

US(1)