ArthritisPACENCT02403687
Prospective Analgesic Compound Efficacy (PACE) Study
An observational study of Arthritis and Tendonitis, run by Express Specialty Pharmacy.
Trial summary
A 24-week observational prospective study on the efficacy of topical non-steroidal anti-inflammatory drugs for the relief of pain. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Arthritis, Tendonitis, Gout
- What is being tested?
- baclofen 2%, Bupivacaine hydrochloride 1% and Cyclobenzaprine hydrochloride 2%
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Feb 2017
- How long will I take part?
- 52 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
A 24-week observational prospective study on the efficacy of topical non-steroidal anti-inflammatory drugs for the relief of pain.
Read the 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
- Being tested
- baclofen 2%, Bupivacaine hydrochloride 1%, Cyclobenzaprine hydrochloride 2%, Diclofenac Sodium 3%, Flurbiprofen 10%
- Medical subject headings
- Arthritis, Tendinopathy, Gout, Radiculopathy, Spasm, Synovitis, Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
baclofen 2%Drug
Also called baclofen
compound topical cream
Bupivacaine hydrochloride 1%Drug
Also called Bupivacaine hydrochloride
compound topical cream
Cyclobenzaprine hydrochloride 2%Drug
Also called Cyclobenzaprine hydrochloride
compound topical cream
Diclofenac Sodium 3%Drug
Also called Diclofenac Sodium
compound topical cream
Flurbiprofen 10%Drug
Also called Flurbiprofen
compound topical cream
Gabapentin 6%Drug
Also called Gabapentin
compound topical cream
Ketamine 10%Drug
Also called Ketamine
compound topical cream
Lidocaine 2%Drug
Also called Lidocaine
compound topical cream
Prilocaine 2.5%Drug
Also called Prilocaine
compound topical cream
Meloxicam 0.09%Drug
Also called Meloxicam
compound topical cream
Sumatriptan 5%Drug
Also called Sumatriptan
compound topical cream
Tizanidine 0.1%Drug
Also called Tizanidine
compound topical cream
Topiramate 2.5%Drug
Also called Topiramate
compound topical cream
Capsaicin, USP 0.0375%Drug
Also called Capsaicin
compound topical cream
Menthol, NF 5.00 %Drug
Also called Menthol
compound topical cream
What is being measured
The primary outcome is the main question the study is designed to answer.
subjective pain control as measured by a 10-point visual analog scale (VAS).
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2016
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
- Target duration
- 52 Weeks
Sponsor and investigators
- Lead sponsor
- Express Specialty Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kate McLellan, Express Specialty Pharmacy
- Investigators
- Kate McLellan, PhD, Study director, KM Clinical, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02403687
- Sponsor's protocol ID
- 1960fp-expr-201501
- Acronym
- PACE
- Status last verified
- Jan 2018
- First submitted
- 5 Mar 2015
- Last updated
- 1 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Analgesic Compound Efficacy (PACE) Study
- ClinicalTrials.gov ID
- NCT02403687
- Acronym / sponsor ID
- PACE / 1960fp-expr-201501
- Conditions
- Arthritis, Tendonitis, Gout, Radiculopathy, Muscle Spasms, Synovitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Express Specialty PharmacyUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 31 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 52 Weeks
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| baclofen 2%Also: baclofencompound topical cream | Drug | – |
| Bupivacaine hydrochloride 1%Also: Bupivacaine hydrochloridecompound topical cream | Drug | – |
| Cyclobenzaprine hydrochloride 2%Also: Cyclobenzaprine hydrochloridecompound topical cream | Drug | – |
| Diclofenac Sodium 3%Also: Diclofenac Sodiumcompound topical cream | Drug | – |
| Flurbiprofen 10%Also: Flurbiprofencompound topical cream | Drug | – |
| Gabapentin 6%Also: Gabapentincompound topical cream | Drug | – |
| Ketamine 10%Also: Ketaminecompound topical cream | Drug | – |
| Lidocaine 2%Also: Lidocainecompound topical cream | Drug | – |
| Prilocaine 2.5%Also: Prilocainecompound topical cream | Drug | – |
| Meloxicam 0.09%Also: Meloxicamcompound topical cream | Drug | – |
| Sumatriptan 5%Also: Sumatriptancompound topical cream | Drug | – |
| Tizanidine 0.1%Also: Tizanidinecompound topical cream | Drug | – |
| Topiramate 2.5%Also: Topiramatecompound topical cream | Drug | – |
| Capsaicin, USP 0.0375%Also: Capsaicincompound topical cream | Drug | – |
| Menthol, NF 5.00 %Also: Mentholcompound topical cream | Drug | – |
Primary outcome
subjective pain control as measured by a 10-point visual analog scale (VAS).
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2018.
- Individual participant dataSharing planned: No
Related trials for Arthritis
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
Recruiting
Autologous Adipose-Derived Stem Cell Injections for Knee Osteoarthritis
Osteoarthritis, Knee
RecruitingPhase 2
A Phase 2a/b Study to Assess the Efficacy, Safety and Tolerability of DDY391 in Participants With Sjögren's Disease
Sjögren's Disease
Recruiting
Exploration of Appropriate BIS Range and Propofol Effect-site Concentration During Total Intravenous Anesthesia With Concomitant Adjuvants.
Knee Osteoarthritis, Replacement, Knee
Not yet recruiting
Platelet-Rich Plasma, Hyaluronic Acid, or Their Combination for Knee Osteoarthritis in Athletes
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kate McLellan, PhD study director
KM Clinical, Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis and Tendonitis, run by Express Specialty Pharmacy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
subjective pain control as measured by a 10-point visual analog scale (VAS). (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2018.