Diabetic Neuropathy Clinical Trial
Official title:
A Double-Blind, Randomized, Multicenter Study With 500 mg QD of TRO19622 Versus Placebo in Patients With Painful Peripheral Diabetic Neuropathy
The purpose of this study is to assess the efficacy and safety of TRO19622 administered PO daily for 6 weeks compared to placebo administered PO daily in patients with painful peripheral diabetic neuropathy.
Diabetic peripheral neuropathic pain (DPNP) affects approximately 11% of patients with
diabetic peripheral neuropathy (DPN). Diabetic neuropathy as the underlying disease is the
most common long-term complication of diabetes mellitus estimated to be experienced by a
majority of patients at least in a mild manner.
Many patients with (DPNP) do not respond adequately to any individual treatment option. None
of the various treatments used can be considered a cure. As a result, although a variety of
drugs are available for the treatment of diabetic neuropathic pain, there is a strong need
to develop new drugs with greater efficacy and/or fewer adverse effects.
The primary objective of the study is to compare the effect of TRO19622 versus placebo on
the 24h neuropathic pain scores during the last 7 days of the 6-week treatment period.
Secondary objectives are to compare the efficacy on neuropathic pain, impact on emotional
functioning, safety profile, pain time course, and response rate of TRO19622 versus placebo.
Additionally, the pharmacokinetics of TRO19622 will be assessed.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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