NCT02403687

Prospective Analgesic Compound Efficacy (PACE) Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 300 (actual)
• Sponsor: Express Specialty Pharmacy · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Objectives The primary objective is the change in pain levels as measured by a 10-point visual analog scale (VAS). Secondary objectives are changes in concomitant pain medication use, quality of life, and patient satisfaction with pain management. Design and Outcomes The study will be conducted at 1 family practice medical clinic in Houston, TX. Patients will be prescribed a pain cream compound based on their symptoms and medical history. Periodic surveys will be administered and concomitant medications recorded to ascertain current pain levels, quality of life, and satisfaction with current pain levels. Blood tests will be performed to monitor liver and kidney function. Interventions and Duration Non-steroidal anti-inflammatory steroid (NSAID) topical cream will be prescribed to patients presenting with pain. For patients with localized pain, they will also be prescribed a transdermal analgesic patch to wear at the site of pain. Subjects will be followed for 24-weeks with surveys administered at baseline, and 1, 2, 4, 8, 12, 16, 20, and 24-weeks after baseline with blood tests performed at 12 and 24-weeks. If patients do not find satisfactory pain relief or experience undesirable side effects from the cream they will be given a prescription for an oral NSAID at anytime during the 24-week observation. Sample Size and Population 500 patients will be enrolled in the study between March 1, 2015 and March 1, 2017. Subjects will be screened from the patient population at 1960 Family Practice, 837 Cupress Creek Parkway, Suite 105, Houston Texas. Subjects will have presented with a primary complaint of pain. Subjects will be stratified by the following medical indications; Arthritis Muscle Spasms Tendonitis Idiopathic Gout Synovitis Radiculopathy Migraine

Conditions

• Arthritis
• Tendonitis
• Gout
• Radiculopathy
• Muscle Spasms
• Synovitis
• Migraine
• Headache

Interventions

Type	Name	Description
DRUG	baclofen 2%	compound topical cream
DRUG	Bupivacaine hydrochloride 1%	compound topical cream
DRUG	Cyclobenzaprine hydrochloride 2%	compound topical cream
DRUG	Diclofenac Sodium 3%	compound topical cream
DRUG	Flurbiprofen 10%	compound topical cream
DRUG	Gabapentin 6%	compound topical cream
DRUG	Ketamine 10%	compound topical cream
DRUG	Lidocaine 2%	compound topical cream
DRUG	Prilocaine 2.5%	compound topical cream
DRUG	Meloxicam 0.09%	compound topical cream
DRUG	Sumatriptan 5%	compound topical cream
DRUG	Tizanidine 0.1%	compound topical cream
DRUG	Topiramate 2.5%	compound topical cream
DRUG	Capsaicin, USP 0.0375%	compound topical cream
DRUG	Menthol, NF 5.00 %	compound topical cream

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-12-01
• Completion: 2017-02-01
• First posted: 2015-03-31
• Last updated: 2018-02-01