An observational study in Arthritis, Tendonitis and Gout, sponsored by Express Specialty Pharmacy. Completed. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2018-02-01.
Sponsored by Express Specialty Pharmacy · Observational
A 24-week observational prospective study on the efficacy of topical non-steroidal anti-inflammatory drugs for the relief of pain.
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
345 studies on the registry are indexed under Gout; 49 are open to participants now.
This study's enrollment of 300 is above the median of 232 across 52 observational studies indexed under Gout.
Browse Gout studies →This is the only study on the registry with Express Specialty Pharmacy as lead sponsor.
Compared within Gout, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Arthritis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
4.2.2 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 .
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
compound topical cream
Also known as: baclofen
compound topical cream
Also known as: Bupivacaine hydrochloride
compound topical cream
Also known as: Cyclobenzaprine hydrochloride
compound topical cream
Also known as: Diclofenac Sodium
compound topical cream
Also known as: Flurbiprofen
compound topical cream
Also known as: Gabapentin
compound topical cream
Also known as: Ketamine
compound topical cream
Also known as: Lidocaine
compound topical cream
Also known as: Prilocaine
compound topical cream
Also known as: Meloxicam
compound topical cream
Also known as: Sumatriptan
compound topical cream
Also known as: Tizanidine
compound topical cream
Also known as: Topiramate
compound topical cream
Also known as: Capsaicin
compound topical cream
Also known as: Menthol
subjective pain control as measured by a 10-point visual analog scale (VAS).
Time frame: 24 weeks
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
The record gives a start of Jun 2015, a primary completion of Dec 2016 and a completion of Feb 2017. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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