Efficacy and Safety of Synera in Osteoarthritis Pain

NCT01654302 | Completed Phase 1 Results

• 1 other identifier: STU00061115
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Knee osteoarthritis (OA) can result in significant pain and limitation of function. A number of topical non-steroidal anti-inflammatory drugs have been shown to reduce pain in this condition. This study examines a different topical approach, utilizing a topical anesthetic agent, to evaluate if application of such an agent would provide relief of exercise-induced knee pain in people with knee OA.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Index Knee Pain Scores on a Numeric Rating Scale (NRS)

  Subject rated index knee pain 5 minutes after stopped experimental exercise (with intervention). Index knee pain was reported using the Numeric Rating Scale, a scale from 0 to 10 where 0 = no pain and 10 = the worst pain possible.

  5 minutes after stopped exercise, performed 1 hour after intervention (patch application)

Study Arms (2)

Synera

ACTIVE COMPARATOR

lidocaine/tetracaine patch with heating component which consists of iron powder, activated carbon, sodium chloride, wood flour, water and filter paper.

Drug: Synera

Inactive Patch

PLACEBO COMPARATOR

placebo patch identical in appearance and composition (namely, the heating components) to the active patch other than lacking the lidocaine and tetracaine active ingredients.

Drug: Inactive patch

Interventions

Synera DRUG

70 mg lidocaine/ 70 mg tetracaine topical patch applied once for 12 hours

Also known as: lidocaine/tetracaine

Synera

Inactive patch DRUG

placebo patch applied once for 12 hours

Also known as: placebo

Inactive Patch

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women, age 40 years and above
• Meet American College of Rheumatology criteria for knee OA
• Knee pain most days of the week for the past month
• Knee pain \> 5/10 after exercise intervention
• Capable of undertaking exercise intervention
• Stable cardiovascular function
• Able to return for all clinic visits
• Able to read and understand the informed consent document

You may not qualify if:

• Use of a walker to ambulate or inability to ambulate
• Other forms of arthritis
• Other major causes of pain that could be expected to interfere with assessment of pain during this trial, e.g., recurrent migraine, back pain, fibromyalgia
• History of myocardial infarction
• Blood Pressure \> 140 systolic/100 diastolic
• Scheduled for and likely to need joint replacement surgery in the next 3 months
• Any medical condition that in the judgment of the investigator would make the participant not suitable for the study
• Sensitivity to lidocaine, topical or injectable analgesics/anesthetics.

Sponsors & Collaborators

• Thomas J. Schnitzer: lead
• Nuvo Research Inc.: collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Lidocaine; Tetracaine

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Julia Marks, CRC
• Organization: Northwestern University

julia.marks@northwestern.edu

312-503-1215

Study Officials

• Thomas J Schnitzer, MD, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 11, 2012
• First Posted: July 31, 2012
• Study Start: September 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: February 1, 2015
• Last Updated: May 12, 2015
• Results First Posted: November 10, 2014

Record last verified: 2015-04

Locations

US (1)