Efficacy Study With 500 mg QD of TRO19622 vs Placebo in Patients With Painful Peripheral Diabetic Neuropathy

NCT ID: NCT00496457

Last Updated: 2016-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 159 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2008-12-31

Brief Summary

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.

Detailed Description

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.

Conditions

Diabetic Neuropathy

Keywords

Diabetic Neuropathy; Painful Peripheral Diabetic Neuropathy; TRO19622; Trophos

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

TRO19622

Group Type: EXPERIMENTAL

Experimental

Intervention Type: DRUG

Capsules of TRO19622 (125 mg)- Once a day before noon meal during 6 weeks

2

Group Type: PLACEBO_COMPARATOR

Placebo comparator

Intervention Type: DRUG

4 Capsules of PBO per day before noon meal

Interventions

Experimental

Capsules of TRO19622 (125 mg)- Once a day before noon meal during 6 weeks

Intervention Type: DRUG

Placebo comparator

4 Capsules of PBO per day before noon meal

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Be a male >18 years or a post-menopausal female (>60 years of age and at least 1 year of amenorrhea).
• Have painful diabetic neuropathy of >6 months duration and are either pain treatment naive or have important side effects or inadequate relief from their current pain medication.
• Be on current pain medication (prescribed analgesics), stable for at least 3 months before study entry (± 25% dosage of basic pain medication, top-up rescue medication allowed), or pain treatment naive.
• Have stable diabetes, defined as HbA1c <10%, no changes in medication in the previous 3 months, and no new symptoms associated with diabetes in the previous 3 months.
• Have scored >2 points on the Michigan Neuropathy Screening Instrument (MNSI), part B-physical assessment by health professional.
• Have an ECG without any clinically significant abnormality.

• Have measurable pain perception (previous 24h) on the Likert numerical rating scale with a mean≥4.0 points calculated from at least 4 daily measurements over the 7 days immediately prior to the Baseline Visit.
• Have stopped current pain medication at least 14 days prior to the Baseline Visit (except rescue medication).

• Have other neurological diseases that may produce weakness, sensory loss, or autonomic symptoms, or laboratory test abnormality.
• Have been on pain treatment with strong opioids, more than 4 different drug regimens in the previous year, or a current combination of more than 2 drugs.
• Have a current medication of lipid lowering agents other than statins.
• Have a body mass index (BMI) >40 kg/m2 (obesity grade III).
• Had any surgery within the previous 2 months.
• Have concurrent serious neurological disease (eg, dementia, multiple sclerosis, or any other disease that would impact the ability of the patient to provide consent for study participation).
• Have a recent history (within the previous 6 months) or current evidence of alcohol or drug abuse.
• Have concurrent unstable disease involving any system (eg, advanced carcinoma, myocardial infarction, clinical or ECG signs of myocardial ischemia, cardiac insufficiency i.e.≥ NYHA functional classification class 2, anginal symptoms, current symptoms of CAD, renal impairment, or any other condition that in the opinion of the Investigator would make the patient unsuitable for study participation).
• Participated in any other investigational drug or therapy study within the previous 3 months.
• Changed or interrupted current well-tolerated medication during the previous 3 months.
• Lack of ability or willingness to give informed consent.
• Be possibly dependent on the Investigator or the Sponsor (eg, including, but not limited to, affiliated employee).
• Have hemostasis disorders or a current treatment of anticoagulants.
• Have non-adequate renal and/or hepatic function as follows:

• Renal - Blood creatinine >1.5X upper limit of normal (ULN)
• Hepatic - Liver enzymes (ALT and AST) >2 X ULN
• Have a known history of or current cardiac dysrhythmias and / or a known history of or current cardiovascular disease including myocardial infarction except patients with well controlled hypertension only.
• Are not able to comply with regard to the known contraindications, warnings and precautions, drug-interactions and dosing recommendations of paracetamol.

Exclusion Criteria

• Be pregnant female, lactating female, or female of child bearing potential (≤60 years of age).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ergomed GmbH

INDUSTRY

Sponsor Role: collaborator

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Louis Abitbol, MD

Role: STUDY_CHAIR

Trophos, Parc Scientifique de Luminy - Case 931, Luminy Biotech Enterprises, 13288 Marseille Cedex9 - France

Dan Ziegler, MD

Role: PRINCIPAL_INVESTIGATOR

German Diabetes Center, German Diabetes Clinic, Leibniz Institute at the Heinrich-Heine University, Auf ´m Hennekamp 65, 40225 Dusseldorf, Germany

Locations

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

IKFE GmbH - Institut für klinische Forschung und Entwicklung - Parcusstr. 8

Mainz, , Germany

Diabetes Schwerpunktpraxis - Gesundheitszentrum Potsdam GmbH - Hebbelstr. 1A

Potsdam, , Germany

Diabetes Schwerpunktpraxis - Gesundheitszentrum Potsdam GmbH, Hebbelstr. 1A

Potsdam, , Germany

Sophien- und Hufeland-Klinikum gGmbH - Klinik für Neurologie und Klinische Neurophysiologie - Henry-van-de-Velde-Str. 2

Weimar, , Germany

Daugavpils Regional Hospital - Vasarnicu street 20

Daugavpils, , Latvia

Zemgale's Diabetes Centre SIA - Zemgales boulevard 15

Jelgava, , Latvia

Doctor's Practice in Endocrinology - Meža prospekts 9, 2nd floor, 41.kabinets

Ogre, , Latvia

Clinical Research Centre "Riga" - Katrinas dambis 16

Riga, , Latvia

Talsu Hospital - Rugena street 7

Talsi, , Latvia

NZOZ Specjalistyczny Ośrodek, Internistyczno-Diabetologiczny, ul Zamenhofa 10/20

Bialystok, , Poland

Centrum Neurologii Klinicznej - Ul. Dwernickiego 8

Krakow, , Poland

NZOZ Special-Med. Ul. Weteranów 46

Lublin, , Poland

NZOZ MEDICA, ul. Jutrzenki 4

Lublin, , Poland

NZOZ Beta-Med., Plac Wolności 17

Rzeszów, , Poland

Adamiec Rajmund Gabinet Lekarski, ul. Żelazna 34

Wroclaw, , Poland

Centre of Neurology, Clinical Hospital Centre "Dr Dragisa Misovic"

Belgrade, , Serbia

Clinic for Neurology and Psychiatry, Clinical Hospital Centre "Zvezdara"

Belgrade, , Serbia

Institute for Endocrinology, Clinical Centre Serbia

Belgrade, , Serbia

Neurology Clinic, Military Medical Academy

Belgrade, , Serbia

Neurology Department, Clinical Hospital Zemun

Belgrade, , Serbia

Center for Neurology, Clinical Centre "Kragujevac"

Kragujevac, , Serbia

Countries

Serbia and Montenegro; Croatia; Germany; Latvia; Poland; Serbia

Other Identifiers

EudraCT Number: 2006-004545-42

Identifier Type: -

Identifier Source: secondary_id

TRO19622 CLEQ 1104-1

Identifier Type: OTHER

Identifier Source: secondary_id

WN29860

Identifier Type: -

Identifier Source: org_study_id