|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | March 13, 2007 | ||||||||
| Last Updated Date | March 13, 2007 | ||||||||
| Start Date ICMJE | April 2007 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE |
pain-free grip strength | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
|
||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Phase II Dose-Ranging Study of OrthoDerm Patch for Patients With Tennis Elbow | ||||||||
| Official Title ICMJE | A Randomized, Double-Blind, Placebo-Controlled Phase II Dose-Ranging Study of the OrthoDerm Transdermal Nitroglycerin Patch for Patients With Chronic Lateral Epicondylitis | ||||||||
| Brief Summary | The purpose of the study is to evaluate the effectiveness and safety of the use of low-dose nitroglycerin transdermal patches to treat pain and function in chronic tennis elbow. |
||||||||
| Detailed Description | Chronic tendonitis remains difficult to treat. Nitric oxide has been demonstrated to stimulate tenocytes to proliferate, differentiate and produce matrix components including collagen. Studies have demonstrated that nitroglycerin transdermal patches, which release nitric oxide, reduce pain and increase function in patients with chronic tendonitis. The purpose of the present study is to examine the efficacy of three dose levels of nitroglycerin, compared to placebo, in reducing pain and increasing function in patients with chronic (greater than three months' duration) lateral epicondylitis. |
||||||||
| Study Phase | Phase II | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||||||
| Condition ICMJE | Tendonitis | ||||||||
| Intervention ICMJE | Drug: OrthoDerm transdermal nitroglycerin patch | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
|
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Enrollment ICMJE | 164 | ||||||||
| Completion Date | November 2007 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 18 Years to 70 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
|
||||||||
| Location Countries ICMJE | Poland | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00447928 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | Orthoderm-1-001-06 | ||||||||
| Study Sponsor ICMJE | Cure Therapeutics | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | Cure Therapeutics | ||||||||
| Verification Date | March 2007 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||
