Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| ResearchPoint | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Dexamethasone Iontophoretic Patch (low dose) |
|
| 2 | Experimental | Dexamethasone Iontophoretic Patch (high dose) |
|
| 3 | Experimental | Dexamethasone Passive Patch |
|
| 4 | Placebo Comparator | Placebo Patch |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone Iontophoretic Patch (low dose) | Drug |
| ||
| Dexamethasone Iontophoretic Patch (high dose) |
| Measure | Description | Time Frame |
|---|---|---|
| Pain severity assessed by VAS (Visual Analog Scale) | baseline to completion/termination |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | up to 13 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Robert Arnold | Travanti Pharma Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
| Dexamethasone Passive Patch | Drug |
|
| Placebo Patch | Drug |
|
| Phoenix |
| Arizona |
| United States |
| Tucson | Arizona | United States |
| San Diego | California | United States |
| Steamboat Springs | Colorado | United States |
| Tampa | Florida | United States |
| Oklahoma City | Oklahoma | United States |
| Columbia | South Carolina | United States |
| Dallas | Texas | United States |
| Arlington | Virginia | United States |
| ID | Term |
|---|---|
| D013716 | Tennis Elbow |
| ID | Term |
|---|---|
| D000070639 | Elbow Tendinopathy |
| D052256 | Tendinopathy |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D000092464 | Elbow Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D013708 | Tendon Injuries |
Not provided
Not provided