|
|
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.
|
|
|
|
Type your Username and Password, then press the Login button.
|
Forgotten your Password? Click here to retrieve it from one of our friendly Customer Service representatives. |
|
|
Clinical Development of TLI-0386 for Treating Diabetic Neuropathy Pain |
TRINITY LABORATORIES INC.
San Antonio, TX |
|
|
|
|
AC = |
Active
|
CO = |
Cross-Over |
CT = |
Controlled |
DB = |
Double-Blind |
DV = |
Device |
IM = |
Intramuscular |
IN = |
Interventional |
IV = |
Intravenous |
MC = |
Multi-Centre |
MG = |
Multi-Group |
NA = |
Non-Active |
NR = |
Non-Randomized |
OL = |
Open-Label |
OR = |
Oral |
PB = |
Placebo |
PD = |
Pharmacokinetics/Dynamics |
PK = |
Pharmacokinetics |
PL = |
Parallel |
PR = |
Prospective |
RD = |
Randomized |
RN = |
No Patient Reimbursement |
Rx = |
Pharmaceutical |
RY = |
Patient Reimbursement |
SB = |
Single-Blind |
SC = |
Single-Centre |
SE = |
Safety/Efficacy |
SG = |
Single Group |
ST = |
Safety |
TP = |
Topical |
TX = |
Treatment |
UC = |
Uncontrolled |
WP = |
Within-Patient |
|
|
|
|
|
Begin Date |
Recruiting Status |
|
|
|
10/2006 |
Open |
|
|
|
|
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. |
|
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. |
|
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%. |
|
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. |
|
|
|
Go to the Course
and take the test |
|
Click here to use your keyboard and chat live online with one of our friendly Customer Service representatives. |
|
