Prospective Analgesic Compound Efficacy (PACE) Study

• Status: Completed
• Trial end date: 2017-02-01
• Target enrollment: 0
• Participant gender: All

Summary

A 24-week observational prospective study on the efficacy of topical non-steroidal anti-inflammatory drugs for the relief of pain.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Express Specialty Pharmacy
• Treatments: Amitriptyline; Analgesics; Baclofen; Bupivacaine; Capsaicin; Clonidine; Cyclobenzaprine; Diclofenac; Flurbiprofen; Gabapentin; Ketamine; Lidocaine; Meloxicam; Menthol; Prilocaine; Sumatriptan; Tizanidine; Topiramate

Criteria

Inclusion Criteria:

• 4.1.1 Primary complaint or clinical findings of arthritis, tendonitis, gout, synovitis, radiculopathy, muscle spasms, migraines, and/or idiopathic pain.

4.1.2 No new pain medications of any kind in the last 4 weeks. 4.1.3 Between the ages of 18-85yrs.

Exclusion Criteria:

• 4.2.1 Current or history of disease or disorders of the liver, kidneys, gastrointestinal system, or cardiovascular system.

4.2.2 Blood test indicating kidney, liver, or cardiovascular function outside of normal clinically accepted ranges. Blood test must be performed in the last 7 days.

4.2.3 Broken or inflamed skin, burns, open wounds, atopic dermatitis or eczema in the area of pain where the compound cream and transdermal patch would be applied.

4.2.4 Women who are pregnant, nursing, or planning to become pregnant in the next 52-weeks.

4.2.5 Allergy/sensitivity to study drugs or their formulations. 4.2.6 Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.

4.2.7 Serious illness (requiring systemic treatment and/or hospitalization) until subject either completes therapy or is clinically stable on therapy, in the opinion of the site investigator, for at least 14 days prior to study entry.

4.2.8 Inability or unwillingness of subject to give written informed consent.