Prospective Analgesic Compound Efficacy (PACE) Study

NCT ID: NCT02403687

Last Updated: 2018-02-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2017-02-28

Brief 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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

baclofen 2%

compound topical cream

Intervention Type: DRUG

Bupivacaine hydrochloride 1%

compound topical cream

Intervention Type: DRUG

Cyclobenzaprine hydrochloride 2%

compound topical cream

Intervention Type: DRUG

Diclofenac Sodium 3%

compound topical cream

Intervention Type: DRUG

Flurbiprofen 10%

compound topical cream

Intervention Type: DRUG

Gabapentin 6%

compound topical cream

Intervention Type: DRUG

Ketamine 10%

compound topical cream

Intervention Type: DRUG

Lidocaine 2%

compound topical cream

Intervention Type: DRUG

Prilocaine 2.5%

compound topical cream

Intervention Type: DRUG

Meloxicam 0.09%

compound topical cream

Intervention Type: DRUG

Sumatriptan 5%

compound topical cream

Intervention Type: DRUG

Tizanidine 0.1%

compound topical cream

Intervention Type: DRUG

Topiramate 2.5%

compound topical cream

Intervention Type: DRUG

Capsaicin, USP 0.0375%

compound topical cream

Intervention Type: DRUG

Menthol, NF 5.00 %

compound topical cream

Intervention Type: DRUG

Other Intervention Names

baclofen; Bupivacaine hydrochloride; Cyclobenzaprine hydrochloride; Diclofenac Sodium; Flurbiprofen; Gabapentin; Ketamine; Lidocaine; Prilocaine; Meloxicam; Sumatriptan; Tizanidine; Topiramate; Capsaicin; Menthol

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Express Specialty Pharmacy

OTHER

Sponsor Role: lead

Responsible Party

Kate McLellan

Study Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kate McLellan, PhD

Role: STUDY_DIRECTOR

KM Clinical, Inc.

Other Identifiers

1960fp-expr-201501

Identifier Type: -

Identifier Source: org_study_id