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Clinical Development of TLI-0386 for Treating Diabetic Neuropathy
Pain focuses on a topical cream containing certain novel
derivatives of capsaicin for the management of pain associated with
diabetic neuropathy.
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Clinical
Development of TLI-0386 for Treating Diabetic Neuropathy Pain
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TRINITY
LABORATORIES INC.
San Antonio, TX
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AC =
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Active
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CO =
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Cross-Over
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CT =
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Controlled
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DB =
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Double-Blind
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DV =
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Device
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IM =
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Intramuscular
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IN =
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Interventional
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IV =
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Intravenous
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MC =
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Multi-Centre
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MG =
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Multi-Group
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NA =
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Non-Active
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NR =
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Non-Randomized
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OL =
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Open-Label
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OR =
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Oral
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PB =
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Placebo
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PD =
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Pharmacokinetics/Dynamics
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PK =
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Pharmacokinetics
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PL =
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Parallel
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PR =
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Prospective
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RD =
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Randomized
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RN =
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No Patient
Reimbursement
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Rx =
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Pharmaceutical
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RY =
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Patient
Reimbursement
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SB =
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Single-Blind
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SC =
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Single-Centre
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SE =
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Safety/Efficacy
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SG =
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Single Group
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ST =
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Safety
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TP =
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Topical
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TX =
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Treatment
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UC =
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Uncontrolled
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WP =
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Within-Patient
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Begin Date
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Recruiting Status
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10/2006
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Open
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Diabetic peripheral
neuropathy is one of the most frequent complications of diabetes and,
in the U.S. alone, affects an estimated 50% of the 18.3 million
individuals who have lived with diabetes for ten or more years.
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Diabetic neuropathy (DN)
is the most common and troublesome complication of diabetes mellitus,
leading to greater morbidity and mortality than all other diabetic
complications combined. Control of pain constitutes one of the most
difficult management issues in DN.
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Capsaicin is a potent
agent for the treatment of various human pain symptoms, including
those of DN. The most frequently encountered adverse effect with
capsaicin is burning pain at the site of the application. This can
make it impossible to blind trials leading to dropout rates ranging
from 33-67%.
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Trinity Labs (TLI), the
Sponsor of this study, has filed a patent for the novel derivatives
of capsaicin for pain management. Furthermore, TLI has produced 0.5%
and 1% cream compositions which have shown remarkable effects in
treating pain associated with DN without the burning side effects.
Based on the preliminary results, TLI has chosen the formulation
TLI-0386 for clinical trial in humans with pain associated with
DN.
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