07-17-2008
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This Phase II study - which is enrolling subjects at 58 trial centers in 19 states and 6 countries – wishes to recruit more than 300 individuals 18 years and older who have been diagnosed with diabetes for at least one year and have peripheral neuropathy (pain & numbness, commonly experienced in the hands and feet).
The trial will study the effectiveness of the orally administered drug [S,S]-Reboxetine over a 10-week course of treatment. As described by one of the 58 trial centers (NewYork-Presbyterian/Weill Cornell Medical Center):
To ease pain and numbness associated with diabetes, … physician-scientists are studying a drug previously used for depression to treat peripheral neuropathy. Diabetics often suffer from this condition because of high blood sugar levels that damage nerve cells. Those with peripheral neuropathy often endure chronic pain, cramping and sleepless nights that prevent them from living a normal lifestyle.
But now, scientists believe that a drug called reboxetine may alleviate their symptoms. The compound works by boosting the level of the neurotransmitter norepinephrine between nerve cells. But it also works by inhibiting the neurotransmitter's degradation within the nerve, where it is stored within the cell for later use.
The trial will measure reboxetine treatment’s impact on measures of pain as well as sleep quality.
For more information see the ClinicalTrials.gov listing for A Trial of [S,S]-Reboxetine in Patients with Chronic Painful Diabetic Peripheral Neuropathy (ID # NCT00625833).
And if you have questions or want specifics on the locations and contact information for trial centers in your area:
1. Call the toll-free Pfizer ClinicalTrials.gov Call Center ( 1-800-718-1021 )
2. A recorded message will ask you to state
- Your name, phone #, city, state and zip code
- The name of the study and its ID number - NCT00625833
3. The call center promises to get back to you "within 2 business days."