Lateral EpicondylitisPhase 2NCT00794976
Dexamethasone Iontophoretic Patch for the Treatment of Pain Associated With Lateral Epicondylitis
A Phase 2 study testing Dexamethasone Iontophoretic Patch (low dose), Dexamethasone Iontophoretic Patch (high dose) and Dexamethasone Passive Patch in people with Lateral Epicondylitis and (Tennis Elbow), run by Travanti Pharma Inc. at 10 sites in United States.
Trial summary
The objective of this study is to determine the safety and efficacy of a dexamethasone iontophoretic transdermal patch for the treatment of pain associated with lateral epicondylitis (tennis elbow). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lateral Epicondylitis, (Tennis Elbow)
- What is being tested?
- Dexamethasone Iontophoretic Patch (low dose), Dexamethasone Iontophoretic Patch (high dose) and Dexamethasone Passive Patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 216 participants
- Where
- 10 sitesUnited States
- Study dates
- Oct 2008to May 2009
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with onset of lateral epicondylitis symptoms no more than 12 weeks prior to study entry
- Female patients of childbearing potential must agree to use a medically accepted form of birth control.
Who cannot join
- Subjects with other medical conditions/injuries of the elbow that would account for pain in the area
- Subjects who would require continuation of current pain medications during treatment
- Must not have received a prior corticosteroid injection for lateral epicondylitis in the affected arm
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Study site
Arlington, Virginia
Study site
Birmingham, Alabama
Study site
Columbia, South Carolina
Study site
Dallas, Texas
Study site
Oklahoma City, Oklahoma
Study site
Phoenix, Arizona
Study site
San Diego, California
Study site
Steamboat Springs, Colorado
Study site
Tampa, Florida
Study site
Tucson, Arizona
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of a Dexamethasone Iontophoretic Transdermal Patch for the Treatment of Pain Associated With Lateral Epicondylitis
The objective of this study is to determine the safety and efficacy of a dexamethasone iontophoretic transdermal patch for the treatment of pain associated with lateral epicondylitis (tennis elbow).
Read the detailed description
Detailed Description:
This trial is a randomized, double-blind, placebo-controlled, parallel-group trial in subjects diagnosed with lateral epicondylitis (tennis elbow). Subjects entered into the trial will be assigned to one of four treatment groups. The total duration is up to 13 days of trial participation.
- Conditions
- Lateral Epicondylitis, (Tennis Elbow)
- Being tested
- Dexamethasone Iontophoretic Patch (low dose), Dexamethasone Iontophoretic Patch (high dose), Dexamethasone Passive Patch, Placebo Patch
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone Iontophoretic Patch (low dose)Drug
Dexamethasone Iontophoretic Patch (high dose)Drug
Dexamethasone Passive PatchDrug
Placebo PatchDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Dexamethasone Iontophoretic Patch (low dose) Receives: Drug: Dexamethasone Iontophoretic Patch (low dose) |
| 2 | Experimental | Dexamethasone Iontophoretic Patch (high dose) Receives: Drug: Dexamethasone Iontophoretic Patch (high dose) |
| 3 | Experimental | Dexamethasone Passive Patch Receives: Drug: Dexamethasone Passive Patch |
| 4 | Placebo comparator | Placebo Patch Receives: Drug: Placebo Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain severity assessed by VAS (Visual Analog Scale)
Measured: baseline to completion/termination
Secondary outcomes (1)
Safety
Measured: up to 13 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2008 (estimated)
- Study startOct 2008
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral EpicondylitisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Travanti Pharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ResearchPoint
- Responsible party
- Sponsor
- Investigators
- Robert Arnold, Study director, Travanti Pharma Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00794976
- Sponsor's protocol ID
- 1779
- Status last verified
- May 2015
- First submitted
- 20 Nov 2008
- Last updated
- 13 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of a Dexamethasone Iontophoretic Transdermal Patch for the Treatment of Pain Associated With Lateral Epicondylitis
- ClinicalTrials.gov ID
- NCT00794976
- Acronym / sponsor ID
- 1779
- Conditions
- Lateral Epicondylitis, (Tennis Elbow)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Travanti Pharma Inc.Industry (pharma, biotech, devices)
- Collaborators
- ResearchPoint
- Study start
- Oct 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 21 Nov 2008 (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 objective of this study is to determine the safety and efficacy of a dexamethasone iontophoretic transdermal patch for the treatment of pain associated with lateral epicondylitis (tennis elbow).
Detailed description
Detailed Description:
This trial is a randomized, double-blind, placebo-controlled, parallel-group trial in subjects diagnosed with lateral epicondylitis (tennis elbow). Subjects entered into the trial will be assigned to one of four treatment groups. The total duration is up to 13 days of trial participation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Dexamethasone Iontophoretic Patch (low dose)Dexamethasone Iontophoretic Patch (low dose) |
| 2 | Experimental | Drug: Dexamethasone Iontophoretic Patch (high dose)Dexamethasone Iontophoretic Patch (high dose) |
| 3 | Experimental | Drug: Dexamethasone Passive PatchDexamethasone Passive Patch |
| 4 | Placebo comparator | Drug: Placebo PatchPlacebo Patch |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects with onset of lateral epicondylitis symptoms no more than 12 weeks prior to study entry
- Female patients of childbearing potential must agree to use a medically accepted form of birth control.
Key exclusion criteria (3 listed)
- Subjects with other medical conditions/injuries of the elbow that would account for pain in the area
- Subjects who would require continuation of current pain medications during treatment
- Must not have received a prior corticosteroid injection for lateral epicondylitis in the affected arm
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 |
|---|---|---|
| Dexamethasone Iontophoretic Patch (low dose) | Drug | 1 |
| Dexamethasone Iontophoretic Patch (high dose) | Drug | 2 |
| Dexamethasone Passive Patch | Drug | 3 |
| Placebo Patch | Drug | 4 |
Primary outcome
Pain severity assessed by VAS (Visual Analog Scale)
Time frame: baseline to completion/termination
1 secondary outcome
Safety
Time frame: up to 13 days
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 13 May 2015.
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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.
Robert Arnold study director
Travanti Pharma Inc.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dexamethasone Iontophoretic Patch (low dose), Dexamethasone Iontophoretic Patch (high dose) and Dexamethasone Passive Patch in people with Lateral Epicondylitis and (Tennis Elbow), run by Travanti Pharma Inc. at 10 sites 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 2 inclusion and 3 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 13 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pain severity assessed by VAS (Visual Analog Scale) (time frame: baseline to completion/termination). 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 13 May 2015.