Clinical trial NCT02403687: Prospective Analgesic Compound Efficacy (PACE) Study
Official title: Prospective Analgesic Compound Efficacy (PACE) Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis
Tendonitis
Gout
Radiculopathy
Muscle Spasms
Synovitis
Migraine
Headache
Lead sponsor: Express Specialty Pharmacy
Sponsor class: OTHER
First posted: 2015-03-31
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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

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.

Primary outcomes:
measure: subjective pain control as measured by a 10-point visual analog scale (VAS).
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: KM Clinical, Inc.
name: Kate McLellan, PhD
role: STUDY_DIRECTOR
References: