BioavailabilityEarly Phase 1NCT03145259
Evaluation of Bioavailability of Diclofenac Dermal Products
A Early Phase 1 study testing Diclofenac Epolamine Patch and diclofenac sodium solution in people with Bioavailability, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
The study will utilize already FDA-approved marketed diclofenac products in healthy adults to generate data for establishing rate of drug delivery comparisons between diclofenac epolamine patches and diclofenac sodium solution in healthy adults and to determine skin concentrations. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioavailability
- What is being tested?
- Diclofenac Epolamine Patch and diclofenac sodium solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2017to 15 May 2020
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men or non-pregnant, women who are of any ethnic background between the age of 18 to 45 years old
- Subjects must be non-smokers (must have refrained from the use of nicotine-containing substances, including tobacco products (e.g., cigarettes, cigars, chewing tobacco, snuff, gum, patches or electronic cigarettes) over the previous 2 months and are not currently using tobacco products
- Provide written informed consent before initiation of any of the study procedures
- Agree not to participate in another clinical trial/study during the study period or to participate in an investigational drug study for at least 1 month after the last study session
- Able to adhere to the study protocol and study restrictions
- Able to participate in all study sessions
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- Has a volar forearm of either at least 24 cm (9.45 inches) in length or of sufficient size that can accommodate the products to be tested in a study area that begins at least 5 cm (1.97 inches) above the wrist and ends a minimum of 0.5 cm (0.197 inches) below the antecubital fossa (i.e., the bend in the arm at the elbow).
- Subjects have upper arms large enough to allow for placement of two 140 cm2 [21.7 in2] patches (distance from acromion process of the scapula to olecranon process should be a minimum of 35 cm [13.8 inches]; circumference of upper arms should be a minimum of 28 cm [11.02 inches] and 200 cm2 [31 in2] area for application of solution
- Subjects deemed to be healthy as judged by the Medically Accountable Investigator (MAI) and determined by medical history, physical examination and medication history
- Negative urine drug screening test (cannabinoids, amphetamines, barbiturates, benzodiazepine, cocaine, methadone, opiates, PCP)
- Have normal screening laboratories for white blood cells (WBC), hemoglobin (Hgb), platelets, sodium, potassium, chloride, bicarbonate, blood urea nitrogen (BUN), creatinine, alanine transaminase (ALT) and aspartate aminotransferase (AST)
- Have normal screening laboratories for urine protein and urine glucose
- Female subjects must be of non-childbearing potential (as defined as surgically sterile [i.e. history of hysterectomy or tubal ligation] or postmenopausal for more than 1 year), or if of childbearing potential must be non-pregnant at the time of enrollment and on the morning of each study session, and must agree to use hormonal or barrier birth control such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence, or a vasectomized partner
- Agrees not to donate blood to a blood bank throughout participation in the study and for at least 3 months after last study session
- Have a normal ECG; must not have the following to be acceptable: pathologic Q wave abnormalities, significant ST-T wave changes, left ventricular hypertrophy, right bundle branch block, left bundle branch block. (sinus rhythm is between 55-100 beats per minute)
- Have normal vital signs:
- Temperature 35-37.9°C (95-100.3°F)
- Systolic blood pressure 90-165 mmHg
- Diastolic blood pressure 60-100 mmHg
- Heart rate 55-100 beats per minute
- Respiration rate 12-20 breaths per minute
Who cannot join
- Women who are pregnant, lactating, breast feeding or have a positive serum pregnancy test at enrollment or positive urine pregnancy test on the morning of the first day of each study session
- Smokers (current use or use over the previous 2 months of nicotine-containing substances, including tobacco products (e.g., cigarettes, cigars, chewing tobacco, snuff, gum, patch or electronic cigarettes)
- Participation in any ongoing investigational drug trial/study or clinical drug trial/study
- History as either reported by the subject or evident to the Medically Accountable Investigator (MAI) of infectious disease or skin infection or of chronic skin disease (e.g., psoriasis, atopic dermatitis)
- History of diabetes
- History of significant skin cancers (e.g., melanoma, squamous cell carcinoma) except basal cell carcinomas that were superficial and did not involve the investigative sites
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- Body Mass Index (BMI) ≥30 kg/m2
- History of chronic obstructive pulmonary disease or cor pulmonale, or substantially decreased respiratory reserve, hypoxia, hypercapnia or pre-existing respiratory depression
- Active positive Hepatitis B, C and/or HIV serologies
- Positive urine drug screening test
- Use of chronic prescription medications during the period 0 to 30 days; or over-the-counter medication (e.g. antihistamines, topical corticosteroids) and short term (<30 days) prescription medications during the period 0-3 days before a study session (vitamins, herbal supplements and birth control medications not included)
- Currently taking daily oral nonsteroidal anti-inflammatory drug [NSAIDs] (aspirin, ibuprofen, naproxen, etc…)
- Currently taking daily anticoagulants or within the past month prior to entry into the study (warfarin, heparin, rivaroxaban, dabigatran, etc…), ACE-inhibitors, cyclosporine, diuretics, lithium or methotrexate
- Donation or loss of greater than one pint of blood within 60 days of entry to the study
- Any prior adverse reaction or hypersensitivity to diclofenac, aspirin, ibuprofen, naproxen or other nonsteroidal anti-inflammatory drug (NSAID), other inactive ingredients in the patch or topical solution or to adhesives or tapes used to cover or tape strip the treatment sites
- Received an experimental agent (vaccine, drug, biologic, device, blood product or medication) within 1 month before enrollment in this study or expects to receive an experimental agent during the study
- Eat or drink anything containing alcohol within 24 hours prior to dose administration
- Any condition that would, in the opinion of the Medically Accountable Investigator (MAI), place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol
- Subject has an obvious difference in skin color between arms or the presence of a skin condition, excessive hair at the application site (upper arms/volar forearms), sunburn, raised moles or scars, open sores at application site (upper arms/volar forearms), scar tissue, tattoo, or coloration that would interfere with placement of diclofenac products, skin assessment, or reactions to diclofenac
- History of asthma or urticaria,, hypertension, myocardial infarction, thrombotic events, stroke, congestive heart failure, impaired renal function or liver disease
- History of gastrointestinal bleeding or peptic ulcer disease
Trial locations and contacts
1 site in 1 country.
United States1 site
General Clinical Research Center (GCRC) at the University of Maryland Medical Center
Baltimore, Maryland, 21201
About this study
The study will utilize already FDA-approved marketed diclofenac products in healthy adults to generate data for establishing rate of drug delivery comparisons between diclofenac epolamine patches and diclofenac sodium solution in healthy adults and to determine skin concentrations.
Read the detailed description
The study will utilize already FDA-approved marketed diclofenac products in healthy adults to generate data for establishing rate of drug delivery comparisons between diclofenac epolamine patches and diclofenac sodium solution in healthy adults and to determine skin concentrations. This study supports FDA's continuing effort to identify the most accurate, sensitive, reproducible and efficient methods to evaluate topical dermatological drug products.
- Conditions
- Bioavailability
- Being tested
- Diclofenac Epolamine Patch, diclofenac sodium solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diclofenac Epolamine PatchDrug
Also called patch
patch
diclofenac sodium solutionDrug
Also called solution
solution
| Study group | Role | What they receive |
|---|---|---|
| Diclofenac patch | Other | Study Session 1: diclofenac epolamine patches (PK) [51 h study duration] Receives: Drug: Diclofenac Epolamine Patch |
| Diclofenac solution | Other | Study Session 2: diclofenac sodium solution (PK) [47 h study duration] Receives: Drug: diclofenac sodium solution |
| Diclofenac patch and solution | Other | Study Session 3: diclofenac epolamine patch pieces and diclofenac sodium solution (no PK, for skin tape stripping) [51 h study duration] Receives: Drug: Diclofenac Epolamine Patch; Drug: diclofenac sodium solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Diclofenac Concentrations
Study Session 1: within 60 min prior to dosing, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 24, 27, 30, 32, 51 h Study Session 2: within 60 min prior to dosing, 1, 2, 3, 4, 5, 6, 7, 23, 26, 29, 31, 47 h Study Session 3: no blood samples obtained
Measured: blood samples obtained over 51 hour time period for study session 1 and over 47 hour time period for study session 2; through study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study start19 Apr 2017
- Primary completion29 Aug 2019
- Study completion15 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BioavailabilityStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- The same 12 volunteers received all treatments in three separate study arms.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Food and Drug Administration (FDA)
- Responsible party
- Principal investigator, Audra Stinchcomb, University of Maryland, Baltimore
- Investigators
- Audra L Stinchcomb, PhD, Principal investigator, University of Maryland Baltimore School of PharmacyHazem E Hassan, PhD, Principal investigator, University of Maryland Baltimore School of Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03145259
- Sponsor's protocol ID
- HP-00067047
- Status last verified
- Jun 2020
- First submitted
- 1 May 2017
- Last updated
- 30 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Bioavailability of Diclofenac Dermal Products
- ClinicalTrials.gov ID
- NCT03145259
- Acronym / sponsor ID
- HP-00067047
- Conditions
- Bioavailability
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Food and Drug Administration (FDA)
- Study start
- 19 Apr 2017 (actual)
- Primary completion
- 29 Aug 2019 (actual)
- Study completion
- 15 May 2020 (actual)
- First posted
- 9 May 2017 (actual)
- Results
- Posted 16 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will utilize already FDA-approved marketed diclofenac products in healthy adults to generate data for establishing rate of drug delivery comparisons between diclofenac epolamine patches and diclofenac sodium solution in healthy adults and to determine skin concentrations.
Detailed description
The study will utilize already FDA-approved marketed diclofenac products in healthy adults to generate data for establishing rate of drug delivery comparisons between diclofenac epolamine patches and diclofenac sodium solution in healthy adults and to determine skin concentrations. This study supports FDA's continuing effort to identify the most accurate, sensitive, reproducible and efficient methods to evaluate topical dermatological drug products.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The same 12 volunteers received all treatments in three separate study arms.
| Arm | Type | Receives |
|---|---|---|
| Diclofenac patch | Other | Drug: Diclofenac Epolamine PatchStudy Session 1: diclofenac epolamine patches (PK) [51 h study duration] |
| Diclofenac solution | Other | Drug: diclofenac sodium solutionStudy Session 2: diclofenac sodium solution (PK) [47 h study duration] |
| Diclofenac patch and solution | Other | Drug: Diclofenac Epolamine Patch, Drug: diclofenac sodium solutionStudy Session 3: diclofenac epolamine patch pieces and diclofenac sodium solution (no PK, for skin tape stripping) [51 h study duration] |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (21 listed)
- Men or non-pregnant, women who are of any ethnic background between the age of 18 to 45 years old
- Subjects must be non-smokers (must have refrained from the use of nicotine-containing substances, including tobacco products (e.g., cigarettes, cigars, chewing tobacco, snuff, gum, patches or electronic cigarettes) over the previous 2 months and are not currently using tobacco products
- Provide written informed consent before initiation of any of the study procedures
- Agree not to participate in another clinical trial/study during the study period or to participate in an investigational drug study for at least 1 month after the last study session
- Able to adhere to the study protocol and study restrictions
Key exclusion criteria (21 listed)
- Women who are pregnant, lactating, breast feeding or have a positive serum pregnancy test at enrollment or positive urine pregnancy test on the morning of the first day of each study session
- Smokers (current use or use over the previous 2 months of nicotine-containing substances, including tobacco products (e.g., cigarettes, cigars, chewing tobacco, snuff, gum, patch or electronic cigarettes)
- Participation in any ongoing investigational drug trial/study or clinical drug trial/study
- History as either reported by the subject or evident to the Medically Accountable Investigator (MAI) of infectious disease or skin infection or of chronic skin disease (e.g., psoriasis, atopic dermatitis)
- History of diabetes
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 |
|---|---|---|
| Diclofenac Epolamine PatchAlso: patchpatch | Drug | Diclofenac patch, Diclofenac patch and solution |
| diclofenac sodium solutionAlso: solutionsolution | Drug | Diclofenac patch and solution, Diclofenac solution |
Primary outcome
Serum Diclofenac Concentrations
Time frame: blood samples obtained over 51 hour time period for study session 1 and over 47 hour time period for study session 2; through study completion
Study Session 1: within 60 min prior to dosing, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 24, 27, 30, 32, 51 h Study Session 2: within 60 min prior to dosing, 1, 2, 3, 4, 5, 6, 7, 23, 26, 29, 31, 47 h Study Session 3: no blood samples obtained
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Audra L Stinchcomb, PhD principal investigator
University of Maryland Baltimore School of Pharmacy
Hazem E Hassan, PhD principal investigator
University of Maryland Baltimore School of Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Diclofenac Epolamine Patch and diclofenac sodium solution in people with Bioavailability, run by University of Maryland, Baltimore at 1 site in United States.
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 21 inclusion and 21 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 30 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Serum Diclofenac Concentrations (time frame: blood samples obtained over 51 hour time period for study session 1 and over 47 hour time period for study session 2; through study completion). 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 30 Jun 2020.