Prospective Analgesic Compound Efficacy (PACE) Study (PACE)

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

Study Overview

• Status: Completed
• Conditions: Arthritis; Migraine; Headache; Radiculopathy; Gout; Synovitis; Tendonitis; Muscle Spasms
• Intervention / Treatment: Drug: baclofen 2%; Drug: Bupivacaine hydrochloride 1%; Drug: Cyclobenzaprine hydrochloride 2%; Drug: Diclofenac Sodium 3%; Drug: Flurbiprofen 10%; Drug: Gabapentin 6%; Drug: Ketamine 10%; Drug: Lidocaine 2%; Drug: Prilocaine 2.5%; Drug: Meloxicam 0.09%; Drug: Sumatriptan 5%; Drug: Tizanidine 0.1%; Drug: Topiramate 2.5%; Drug: Capsaicin, USP 0.0375%; Drug: Menthol, NF 5.00 %

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

• Study Type: Observational
• Enrollment (Actual): 300

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The patient population will be taken from the patients normally treated at 1960 Family Practice. Patients not approached for the study will have known medical issues consistent with the exclusion criteria. Patients who can meet the medical requirements of the inclusion criteria for the study will be asked to participate. Patients who do not meet the inclusion criteria, meet any of the exclusion criteria, or decline to be involved in the study will be treated with traditional standard medical practices, and their standard of care will not change in any way.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
subjective pain control as measured by a 10-point visual analog scale (VAS).	24 weeks

Collaborators and Investigators

• Sponsor: Express Specialty Pharmacy
• Investigators: Study Director: Kate McLellan, PhD, KM Clinical, Inc.

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (ACTUAL): December 1, 2016
• Study Completion (ACTUAL): February 1, 2017

Study Registration Dates

• First Submitted: March 5, 2015
• First Submitted That Met QC Criteria: March 30, 2015
• First Posted (ESTIMATE): March 31, 2015

Study Record Updates

• Last Update Posted (ACTUAL): February 1, 2018
• Last Update Submitted That Met QC Criteria: January 30, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Tendon Injuries; Peripheral Nervous System Diseases; Neuromuscular Manifestations; Tendinopathy; Headache; Radiculopathy; Spasm; Synovitis; Hypoglycemic Agents; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Central Nervous System Depressants; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Dermatologic Agents; Tranquilizing Agents; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Anti-Anxiety Agents; GABA Agents; Anticonvulsants; Antidepressive Agents, Tricyclic; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Antimanic Agents; Cyclooxygenase 2 Inhibitors; Neuromuscular Agents; Antipruritics; Adrenergic Uptake Inhibitors; Sympatholytics; Vasoconstrictor Agents; Muscle Relaxants, Central; GABA Agonists; GABA-B Receptor Agonists; Ketamine; Lidocaine; Gabapentin; Prilocaine; Bupivacaine; Diclofenac; Amitriptyline; Clonidine; Topiramate; Capsaicin; Meloxicam; Baclofen; Menthol; Flurbiprofen; Tizanidine; Cyclobenzaprine; Sumatriptan
• Other Study ID Numbers: 1960fp-expr-201501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO