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
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04025320 -
The Effect of Intraneural Facilitation Therapy on Diabetic Patients With Peripheral Neuropathy
|
N/A | |
| Completed |
NCT02659007 -
Less Neuropathy After Yoga- Managing Diabetic Neuropathy With Yoga
|
Phase 1 | |
| Completed |
NCT01953757 -
A Nutritional Intervention for Diabetic Neuropathy (WCCR-DN2)
|
N/A | |
| Completed |
NCT01707979 -
NIR- and Multifrequent Impedance Spectroscopy on the Skin in Type 1 Diabetes
|
N/A | |
| Completed |
NCT00608439 -
Centella Asiatica Selected Triterpenes (CAST) for Diabetic Neuropathy
|
Phase 2 | |
| Completed |
NCT00576277 -
Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AV411 in Neuropathic Pain
|
Phase 1/Phase 2 | |
| Completed |
NCT00235443 -
A Follow-On Trial to Assess the Long Term Safety and Efficacy of SPM 927 in Painful Distal Diabetic Neuropathy
|
Phase 2/Phase 3 | |
| Completed |
NCT00830011 -
Cognitive Behavioral Therapy for Painful Diabetic Neuropathy
|
N/A | |
| Completed |
NCT00931879 -
Lovaza® and Microvascular Function in Type 2 Diabetes
|
Phase 4 | |
| Completed |
NCT00190970 -
The Effect of Ruboxistaurin on Small Fiber Function
|
Phase 2 | |
| Completed |
NCT00101426 -
Safety and Efficacy of AS-3201 in the Treatment of Diabetic Sensorimotor Polyneuropathy
|
Phase 3 | |
| Completed |
NCT00238550 -
Study of CBME in the Relief of Painful Diabetic Neuropathy
|
Phase 2 | |
| Completed |
NCT05573685 -
Basket Study (CT-100-002) to Evaluate the Effects of a DiNaMo™ Component Training
|
N/A | |
| Recruiting |
NCT02341261 -
Activity for Diabetic Polyneuropathy
|
N/A | |
| Completed |
NCT01822925 -
Study of DA-9801 to Treat Diabetic Neuropathy
|
Phase 2 | |
| Completed |
NCT01690962 -
A Nutritional Intervention for Diabetic Neuropathy
|
N/A | |
| Terminated |
NCT00993018 -
A Study of Effectiveness and Safety of JNJ-42160443 in Patients With Diabetic Painful Neuropathy
|
Phase 2 | |
| Withdrawn |
NCT02315235 -
The Peripheral Mobilized Mononuclear Cell-based Therapy in Patient With Diabetic Neuropathy
|
N/A | |
| Recruiting |
NCT02606747 -
The Balance Control Mechanism of DPN Patients
|
N/A | |
| Completed |
NCT02068027 -
Study of Clonidine Hydrochloride Topical Gel, 0.1% in the Treatment of Pain Associated With Diabetic Neuropathy
|
Phase 2 |