Prospective Analgesic Compound Efficacy (PACE) Study

Migraine Clinical Trial

— PACE  

Official title:

Prospective Analgesic Compound Efficacy (PACE) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02403687
• Other study ID #: 1960fp-expr-201501
• Status: Completed
• Phase: N/A
• First received: March 5, 2015
• Last updated: January 30, 2018
• Start date: June 2015
• Est. completion date: February 2017

Study information

• Verified date: January 2018
• Source: Express Specialty Pharmacy
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: February 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Express Specialty Pharmacy

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	subjective pain control as measured by a 10-point visual analog scale (VAS).		24 weeks