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Prospective Analgesic Compound Efficacy (PACE) Study (PACE)

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ClinicalTrials.gov Identifier: NCT02403687
Recruitment Status : Completed
First Posted : March 31, 2015
Last Update Posted : February 1, 2018
Sponsor:
Information provided by (Responsible Party):
Kate McLellan, Express Specialty Pharmacy

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

Condition or disease Intervention/treatment
Arthritis Tendonitis Gout Radiculopathy Muscle Spasms Synovitis Migraine Headache 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


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Study Type : Observational [Patient Registry]
Actual Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 52 Weeks
Official Title: Prospective Analgesic Compound Efficacy (PACE) Study
Study Start Date : June 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  1. subjective pain control as measured by a 10-point visual analog scale (VAS). [ Time Frame: 24 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02403687


Sponsors and Collaborators
Express Specialty Pharmacy
Investigators
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Study Director: Kate McLellan, PhD KM Clinical, Inc.

Additional Information:

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Responsible Party: Kate McLellan, Study Director, Express Specialty Pharmacy
ClinicalTrials.gov Identifier: NCT02403687     History of Changes
Other Study ID Numbers: 1960fp-expr-201501
First Posted: March 31, 2015    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Tendinopathy
Synovitis
Radiculopathy
Spasm
Headache
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Muscular Diseases
Tendon Injuries
Wounds and Injuries
Neuromuscular Manifestations
Topiramate
Diclofenac
Meloxicam
Flurbiprofen
Lidocaine
Sumatriptan
Ketamine
Gabapentin
Amitriptyline
Tizanidine
Bupivacaine
Prilocaine
Cyclobenzaprine