Phase II Dose-Ranging Study of OrthoDerm Patch for Patients With Tennis Elbow
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by Cure Therapeutics.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Cure Therapeutics
Information provided by:
Cure Therapeutics
ClinicalTrials.gov Identifier:
NCT00447928
First received: March 13, 2007
Last updated: NA
Last verified: March 2007
History: No changes posted
| Tracking Information | |||||||||
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| First Received Date ICMJE | March 13, 2007 | ||||||||
| Last Updated Date | March 13, 2007 | ||||||||
| Start Date ICMJE | April 2007 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| 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 |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 2 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
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| Condition ICMJE | Tendonitis | ||||||||
| Intervention ICMJE | Drug: OrthoDerm transdermal nitroglycerin patch | ||||||||
| Study Arm (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Enrollment ICMJE | 164 | ||||||||
| Completion Date | November 2007 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 70 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Poland | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00447928 | ||||||||
| Other Study ID Numbers ICMJE | Orthoderm-1-001-06 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Not Provided | ||||||||
| Study Sponsor ICMJE | Cure Therapeutics | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Cure Therapeutics | ||||||||
| Verification Date | March 2007 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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