Lateral Epicondylitis (Tennis Elbow)Phase 1NCT00895076
Study to Compare the Pharmacokinetics of a Dexamethasone Iontophoretic Patch to a Dexamethasone Injection
A Phase 1 study testing dexamethasone in people with Lateral Epicondylitis (Tennis Elbow), run by Travanti Pharma Inc. at 1 site in United States.
Trial summary
The primary objectives are to evaluate the extent of systemic exposure and dexamethasone bioavailability following a single application of a dexamethasone iontophoretic transdermal patch in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Lateral Epicondylitis (Tennis Elbow)
- What is being tested?
- dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to May 2009
- Phase
- Phase 1
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men or women aged 18 Years to 45 Years
- Must have a Body Mass Index (BMI) between 18 and 29 kg/m2, inclusive.
- Must, in the investigator's opinion, have no clinically significant disease as determined by medical and psychiatric history, physical examination, vital signs, and/or laboratory evaluations conducted at the screening visit or on clinic admission that would interfere with the evaluation of safety or pharmacokinetics.
- Must have negative screens for Hbs-Ag, HCV-Ab, and HIV-Ab, and no history of a positive result.
- Female subjects may be included if they are surgically sterile or 2 years post menopausal, and they have a negative serum pregnancy test at screening. Female subjects of child bearing potential and peri-menopausal subjects may be included if they have a negative serum pregnancy test at screening and on admission to the clinic on Day -1, and agree to use a medically accepted method of birth control (e.g., barrier method with spermicide, oral contraceptive, or abstinence) and agree to continue use of this method for the duration of the trial.
- Must be non-smokers, defined as not having smoked tobacco, used chewing tobacco, or used nicotine-containing products for smoking cessation in the 6 months prior to screening.
- Must be able to communicate effectively with the study personnel.
- Must agree to remain in the study facility overnight for approximately five consecutive days and nights.
Who cannot join
- Is a female subject who is pregnant, breastfeeding, or planning a pregnancy during the study.
- Has a clinically significant unstable medical abnormality, chronic disease, significant neurological (including seizure and cognitive disorders), hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, or metabolic disease, or any other abnormality that could interfere with the PK evaluation of the study drug. Particular attention will be paid to exclude subjects with a risk for the consequences of systemic corticosteroid exposure, such as diabetes or poorly controlled hypertension.
- Has had a clinically significant illness within 30 days of Screening.
- Use of any prescription medication (other than hormonal contraceptives) within 14 days or over-the-counter (OTC) medication (with the exception of ibuprofen and acetaminophen) within 7 days of randomization or intends to use any prescription or OTC medication during the study that may interfere with the evaluation of the study drug.
- Use of any topical creams, lotions or oils on the patch application site within 2 weeks of treatment administration in the first period and throughout the study.
- Use of any steroid, including topical steroid, within 4 weeks of treatment administration in the first period and throughout the study.
Show all 20Show fewer
- Intake of grapefruit products, and foods, herbal products and over-the-counter or prescription medications that may interact with the CYP450 enzyme system from 7 days prior to treatment administration in the first period until completion of the end-of-study procedures.
- Has ingested alcohol within 24 hours before admission (Day -1) and throughout the study.
- Has a history of significant allergy or hypersensitivity to the study drugs or to any component of iontophoretic transdermal patch used in this study, including allergy or sensitivity to bandage adhesives or to sodium bisulfate.
- Has any of the following exclusionary clinical laboratory results:
- Hemoglobin less than 12.0 g/dL
- Serum creatinine greater than 2.0 mg/dL
- Abnormal liver function tests (serum glutamic oxaloacetic transaminase [SGOT], also called aspartate transaminase [AST]; or serum glutamic pyruvic transaminase [SGPT], also called alanine transaminase [ALT] more than twice the upper limit of normal)
- Elevated serum bilirubin more than 2 times the upper limit of normal
- Any blood donation or significant blood loss within 90 days of treatment administration in the first period.
- Any plasma donation within 7 days of randomization.
- Has any sensory dysfunction, any skin irritation, sensitivity or disease, or a tattoo that may in the opinion of the investigator interfere with assessment of topical effects at the site of patch application.
- Has history of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or any history of drug abuse or addiction within 12 months of study enrollment.
- Has or develops a positive urine drug screen, including ethanol, cocaine, tetrahydrocannabinol, barbiturates, amphetamines, benzodiazepines, and opiates.
- Use of any other investigational drug within 30 days or five half-lives (whichever is longer) before treatment administration in the first period, or plans to use an investigational drug (other than the study drugs) during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-Label, Single Dose, Two-Way Crossover Study to Evaluate the Pharmacokinetics and Safety of a Dexamethasone Iontophoretic Transdermal Patch Compared to Dexamethasone Injection in Healthy Adult Volunteers
The primary objectives are to evaluate the extent of systemic exposure and dexamethasone bioavailability following a single application of a dexamethasone iontophoretic transdermal patch in healthy volunteers.
The secondary objectives are to evaluate the systemic and topical safety of the dexamethasone iontophoretic transdermal patch and of the dexamethasone intramuscular (IM) injection.
- Conditions
- Lateral Epicondylitis (Tennis Elbow)
- Being tested
- dexamethasone
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexamethasoneDrug
iontophoretic patch and injection
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | dexamethasone iontophoretic patch Receives: Drug: dexamethasone |
| 2 | Active comparator | dexamethasone intramuscular injection Receives: Drug: dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objectives are to evaluate the extent of systemic exposure and dexamethasone bioavailability following a single application of a dexamethasone iontophoretic transdermal patch in healthy volunteers.
Measured: 0-33 hours
Pharmacokinetics and safety of dexamethasone iontophoretic patch
Measured: 0-33 hours
Secondary outcomes (1)
The secondary objectives are to evaluate the systemic and topical safety of the dexamethasone iontophoretic transdermal patch and of the dexamethasone IM injection.
Measured: 0-33 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2009 (estimated)
- Study startMay 2009
- Primary completionMay 2009 (estimated)
- Study completionMay 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral Epicondylitis (Tennis Elbow)Studies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Travanti Pharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cetero Research, San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00895076
- Sponsor's protocol ID
- 2019
- Status last verified
- May 2009
- First submitted
- 6 May 2009
- Last updated
- 7 May 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Single Dose, Two-Way Crossover Study to Evaluate the Pharmacokinetics and Safety of a Dexamethasone Iontophoretic Transdermal Patch Compared to Dexamethasone Injection in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT00895076
- Acronym / sponsor ID
- 2019
- Conditions
- Lateral Epicondylitis (Tennis Elbow)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Travanti Pharma Inc.Industry (pharma, biotech, devices)
- Collaborators
- Cetero Research, San Antonio
- Study start
- May 2009
- Primary completion
- May 2009 (estimated)
- Study completion
- May 2009 (estimated)
- First posted
- 7 May 2009 (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.
The primary objectives are to evaluate the extent of systemic exposure and dexamethasone bioavailability following a single application of a dexamethasone iontophoretic transdermal patch in healthy volunteers.
The secondary objectives are to evaluate the systemic and topical safety of the dexamethasone iontophoretic transdermal patch and of the dexamethasone intramuscular (IM) injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: dexamethasonedexamethasone iontophoretic patch |
| 2 | Active comparator | Drug: dexamethasonedexamethasone intramuscular injection |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Men or women aged 18 Years to 45 Years
- Must have a Body Mass Index (BMI) between 18 and 29 kg/m2, inclusive.
- Must, in the investigator's opinion, have no clinically significant disease as determined by medical and psychiatric history, physical examination, vital signs, and/or laboratory evaluations conducted at the screening visit or on clinic admission that would interfere with the evaluation of safety or pharmacokinetics.
- Must have negative screens for Hbs-Ag, HCV-Ab, and HIV-Ab, and no history of a positive result.
- Female subjects may be included if they are surgically sterile or 2 years post menopausal, and they have a negative serum pregnancy test at screening. Female subjects of child bearing potential and peri-menopausal subjects may be included if they have a negative serum pregnancy test at screening and on admission to the clinic on Day -1, and agree to use a medically accepted method of birth control (e.g., barrier method with spermicide, oral contraceptive, or abstinence) and agree to continue use of this method for the duration of the trial.
Key exclusion criteria (20 listed)
- Is a female subject who is pregnant, breastfeeding, or planning a pregnancy during the study.
- Has a clinically significant unstable medical abnormality, chronic disease, significant neurological (including seizure and cognitive disorders), hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, or metabolic disease, or any other abnormality that could interfere with the PK evaluation of the study drug. Particular attention will be paid to exclude subjects with a risk for the consequences of systemic corticosteroid exposure, such as diabetes or poorly controlled hypertension.
- Has had a clinically significant illness within 30 days of Screening.
- Use of any prescription medication (other than hormonal contraceptives) within 14 days or over-the-counter (OTC) medication (with the exception of ibuprofen and acetaminophen) within 7 days of randomization or intends to use any prescription or OTC medication during the study that may interfere with the evaluation of the study drug.
- Use of any topical creams, lotions or oils on the patch application site within 2 weeks of treatment administration in the first period and throughout the study.
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 |
|---|---|---|
| dexamethasoneiontophoretic patch and injection | Drug | 1, 2 |
Primary outcome
The primary objectives are to evaluate the extent of systemic exposure and dexamethasone bioavailability following a single application of a dexamethasone iontophoretic transdermal patch in healthy volunteers.
Time frame: 0-33 hours
Pharmacokinetics and safety of dexamethasone iontophoretic patch
Time frame: 0-33 hours
1 secondary outcome
The secondary objectives are to evaluate the systemic and topical safety of the dexamethasone iontophoretic transdermal patch and of the dexamethasone IM injection.
Time frame: 0-33 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing dexamethasone in people with Lateral Epicondylitis (Tennis Elbow), run by Travanti Pharma Inc. 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 8 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 7 May 2009. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
The primary objectives are to evaluate the extent of systemic exposure and dexamethasone bioavailability following a single application of a dexamethasone iontophoretic transdermal patch in healthy volunteers. (time frame: 0-33 hours). The study lists 2 primary outcomes in all. 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 7 May 2009.