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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
159
Capsules of TRO19622 (125 mg)- Once a day before noon meal during 6 weeks
4 Capsules of PBO per day before noon meal
Effect of TRO19622 versus Placebo on the mean 24h neuropathic pain score on the Likert numerical rating scale.
Time frame: During the last 7 days of the 6-week treatment period
24h Pain time course
Time frame: Duration of study (within 11weeks after screening)
Analysis for treatment effects: SF-MPQ, SF-BPI, SF36, POMS, Global Impression of Change (Patient / Investigator)
Time frame: Within 6 weeks of treatment
Adverse events
Time frame: During the course of the study.
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Univerity Hospital OSIJEK, Department for Diabetes and Endocrinology, J.Huttlera 4
Osijek, Croatia
Genaral Hospital "Josip Bencevic", Internal Medicine Department-Unit for Diabetes, Andrije Stampara 42
Slavonski Brod, Croatia
General Hospital Varazdin, Internal Medicine Department-Unit for Diabetes, Ivana Mestrovica bb
Varaždin, Croatia
University Hospital "Dubrava", University Department for Internal Medicine, Institut for Diabetes, Endocrinology and Metabolic diseases, Avenija Gojka Suska 6
Zagreb, Croatia
Diabetes Zentrum Mergentheim - Theodor-Klotzbücher-Straße 12
Bad Mergentheim, Germany
Diabetologische Schwerpunktpraxis - Wilhelminenstr. 22
Dinslaken-Bruch, Germany
Deutsches Diabetes Center, Institut für Klinische Diabetologie, Leibniz-Zentrum an der Heinrich-Heine Universität - Auf'm Hennekamp 65
Düsseldorf, Germany
Klinikum Region Hannover GmbH - Klinikum Hannover Nordstadt - Diabetes Schwerpunktklinik -Medizinische Klinik - Haltenhoffstr. 41
Hanover, Germany
Universitätsklinikum Heidelberg - Abteilung Innere Medizin I und klinische Chemie - Im Neuenheimer Feld 410
Heidelberg, Germany
Pro scientia med - Osterweide 10
Lübeck, Germany
...and 21 more locations