Prospective Analgesic Compound Efficacy (PACE) Study
PACE
1 other identifier
observational
300
0 countries
N/A
Brief Summary
A 24-week observational prospective study on the efficacy of topical non-steroidal anti-inflammatory drugs for the relief of pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2015
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2015
CompletedFirst Posted
Study publicly available on registry
March 31, 2015
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedFebruary 1, 2018
January 1, 2018
1.5 years
March 5, 2015
January 30, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
subjective pain control as measured by a 10-point visual analog scale (VAS).
24 weeks
Interventions
compound topical cream
Eligibility Criteria
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.
You may qualify if:
- Primary complaint or clinical findings of arthritis, tendonitis, gout, synovitis, radiculopathy, muscle spasms, migraines, and/or idiopathic pain.
- No new pain medications of any kind in the last 4 weeks. 4.1.3 Between the ages of 18-85yrs.
You may not qualify if:
- Current or history of disease or disorders of the liver, kidneys, gastrointestinal system, or cardiovascular system.
- Blood test indicating kidney, liver, or cardiovascular function outside of normal clinically accepted ranges. Blood test must be performed in the last 7 days.
- 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.
- Women who are pregnant, nursing, or planning to become pregnant in the next 52-weeks.
- 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.
- 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.
- Inability or unwillingness of subject to give written informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kate McLellan, PhD
KM Clinical, Inc.
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 52 Weeks
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Study Director
Study Record Dates
First Submitted
March 5, 2015
First Posted
March 31, 2015
Study Start
June 1, 2015
Primary Completion
December 1, 2016
Study Completion
February 1, 2017
Last Updated
February 1, 2018
Record last verified: 2018-01
Data Sharing
- IPD Sharing
- Will not share