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

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Efficacy Study With 500 mg QD of TRO19622 vs Placebo in Patients With Painful Peripheral Diabetic Neuropathy
This study is currently recruiting participants.
Verified by Trophos, May 2008
Sponsors and Collaborators: Trophos
Ergomed GmbH Altenhoferallee 3, 64138 Frankfurt am Main, Germany

Information provided by: Trophos
ClinicalTrials.gov Identifier: NCT00496457

Purpose
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.

Condition Intervention Phase
Diabetic Neuropathy
Drug: Experimental
Drug: Placebo comparator
Phase II

MedlinePlus related topics: Diabetes Diabetic Nerve Problems
U.S. FDA Resources
Study Type:Interventional
Study Design:Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:A Double-Blind, Randomized, Multicenter Study With 500 mg QD of TRO19622 Versus Placebo in Patients With Painful Peripheral Diabetic Neuropathy

Further study details as provided by Trophos:

Primary Outcome Measures:
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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
24h Pain time course [ Time Frame: Duration of study (within 11weeks after screening) ] [ Designated as safety issue: Yes ]

Analysis for treatment effects: SF-MPQ, SF-BPI, SF36, POMS, Global Impression of Change (Patient / Investigator) [ Time Frame: Within 6 weeks of treatment ] [ Designated as safety issue: Yes ]

Adverse events [ Time Frame: During the course of the study. ] [ Designated as safety issue: Yes ]

Estimated Enrollment:180
Study Start Date:May 2007
Estimated Study Completion Date:October 2008
Estimated Primary Completion Date:October 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
TRO19622 Drug: Experimental
Capsules of TRO19622 (125 mg)- Once a day before noon meal during 6 weeks
2: Placebo Comparator Drug: Placebo comparator
4 Capsules of PBO per day before noon meal

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.

Eligibility
Ages Eligible for Study:18 Years and older
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No
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.
The following inclusion criteria should be ascertained at the baseline visit:

Have measurable pain perception (previous 24h) on the Likert numerical rating scale with a mean&#8805;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).
Exclusion Criteria:

Be pregnant female, lactating female, or female of child bearing potential (&#8804;60 years of age).
Have a documented neuropathy of any cause other than those mentioned in the inclusion criteria which might interfere with the assessment of the severity of pain (eg, including, but not limited to, alcoholic, uremic, B12, TSH, chemotherapy, HIV, post surgical, or post-traumatic neuropathy).
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.&#8805; 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.
Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00496457

Locations
Croatia
University Hospital "Dubrava", University Department for Internal Medicine, Institut for Diabetes, Endocrinology and Metabolic diseases, Avenija Gojka Suska 6 Completed
Zagreb, Croatia, 10 000
Univerity Hospital OSIJEK, Department for Diabetes and Endocrinology, J.Huttlera 4 Completed
OSIJEK, Croatia, 31 000
Genaral Hospital "Josip Bencevic", Internal Medicine Department-Unit for Diabetes, Andrije Stampara 42 Completed
SLAVONSKI BROD, Croatia, 35 000
General Hospital Varazdin, Internal Medicine Department-Unit for Diabetes, Ivana Mestrovica bb Completed
VARAZDIN, Croatia, 42 000
Germany
Deutsches Diabetes Center, Institut für Klinische Diabetologie, Leibniz-Zentrum an der Heinrich-Heine Universität - Auf'm Hennekamp 65 Completed
Duesseldorf, Germany, 40225
IKFE GmbH - Institut für klinische Forschung und Entwicklung - Parcusstr. 8 Completed
Mainz, Germany, 55116
Universitätsklinikum Heidelberg - Abteilung Innere Medizin I und klinische Chemie - Im Neuenheimer Feld 410 Completed
Heidelberg, Germany, 69120
Diabetes Schwerpunktpraxis - Gesundheitszentrum Potsdam GmbH, Hebbelstr. 1A Completed
Potsdam, Germany, 14467
Diabetologische Schwerpunktpraxis - Wilhelminenstr. 22 Completed
Dinslaken-Bruch, Germany, 46537
Sophien- und Hufeland-Klinikum gGmbH - Klinik für Neurologie und Klinische Neurophysiologie - Henry-van-de-Velde-Str. 2 Completed
Weimar, Germany, 99425
Klinikum Region Hannover GmbH - Klinikum Hannover Nordstadt - Diabetes Schwerpunktklinik -Medizinische Klinik - Haltenhoffstr. 41 Completed
Hannover, Germany, 30167
Pro scientia med - Osterweide 10 Completed
Lübeck, Germany, 23562
Diabetes Zentrum Mergentheim - Theodor-Klotzbücher-Straße 12 Completed
Bad Mergentheim, Germany, 97980
Diabetes Schwerpunktpraxis - Gesundheitszentrum Potsdam GmbH - Hebbelstr. 1A Completed
Potsdam, Germany, 14467
Latvia
Talsu Hospital - Rugena street 7 Recruiting
Talsi, Latvia, LV-3201
Contact: Valda Stalte, MD 00371 29490105
Principal Investigator: Valda Stalte, MD
Clinical Research Centre "Riga" - Katrinas dambis 16 Recruiting
Riga, Latvia, LV-1045
Contact: Agnis Zvagzne, MD 00371 29286688
Principal Investigator: Agnis Zvagzne, MD
Doctor's Practice in Endocrinology - Meža prospekts 9, 2nd floor, 41.kabinets Recruiting
Ogre, Latvia, LV-5001
Contact: Dace Teterovska, MD 00371 29472974
Principal Investigator: Dace Teterovska, MD
Zemgale's Diabetes Centre SIA - Zemgales boulevard 15 Recruiting
Jelgava, Latvia, LV-3000
Contact: Sigita Pastare, MD 00371 29165681
Principal Investigator: Sigita Pastare, MD
Daugavpils Regional Hospital - Vasarnicu street 20 Recruiting
Daugavpils, Latvia, LV-5420
Contact: Jelena Sokolova, MD 00371 26559072
Principal Investigator: Jelena Sokolova, MD
Poland
NZOZ MEDICA, ul. Jutrzenki 4 Not yet recruiting
Lublin, Poland, 20-538
Contact: Monika Bojarska-&#321;o&#347;, MD 0048 81 526 84 41
Principal Investigator: Monika Bojarska-&#321;o&#347;, MD
Adamiec Rajmund Gabinet Lekarski, ul. &#379;elazna 34 Recruiting
Wroc&#322;aw, Poland, 53-428
Contact: Rajmund Adamiec, MD 0048 71 733 22 00
Principal Investigator: Rajmund Adamiec, MD
NZOZ Special-Med. Ul. Weteranów 46 Recruiting
Lublin, Poland, 20-044
Contact: Ewa Szyprowska, MD 0048 693 397 831
Principal Investigator: Ewa Szyprowska, MD
Centrum Neurologii Klinicznej - Ul. Dwernickiego 8 Not yet recruiting
Kraków, Poland, 31-530
Contact: Andrzej Szczudlik, MD 0048 12 426 92 80
Principal Investigator: Andrzej Szczudlik, MD
NZOZ Beta-Med., Plac Wolno&#347;ci 17 Recruiting
Rzeszów, Poland, 35-073
Contact: Mariusz D&#261;browski, MD 0048 17 859 15 60
Principal Investigator: Mariusz D&#261;browski, MD
NZOZ Specjalistyczny O&#347;rodek, Internistyczno-Diabetologiczny, ul Zamenhofa 10/20 Recruiting
Bia&#322;ystok, Poland, 15-435
Contact: Ma&#322;gorzata Arciszewska, MD 0048 85 664 40 50
Principal Investigator: Ma&#322;gorzata Arciszewska, MD
Serbia and Montenegro
Neurology Clinic, Military Medical Academy Completed
Belgrade, Serbia and Montenegro, 11000
Institute for Endocrinology, Clinical Centre Serbia Completed
Belgrade, Serbia and Montenegro, 11000
Clinic for Neurology and Psychiatry, Clinical Hospital Centre "Zvezdara" Completed
Belgrade, Serbia and Montenegro, 11000
Neurology Department, Clinical Hospital Zemun Completed
Belgrade, Serbia and Montenegro, 11000
Center for Neurology, Clinical Centre "Kragujevac" Completed
Kragujevac, Serbia and Montenegro, 34000
Centre of Neurology, Clinical Hospital Centre "Dr Dragisa Misovic" Completed
Belgrade, Serbia and Montenegro, 11000

Sponsors and Collaborators
Trophos
Ergomed GmbH Altenhoferallee 3, 64138 Frankfurt am Main, Germany
Investigators
Study Chair: Jean-Louis Abitbol, MD Trophos, Parc Scientifique de Luminy - Case 931, Luminy Biotech Enterprises, 13288 Marseille Cedex9 - France
Principal Investigator: Dan Ziegler, MD German Diabetes Center, German Diabetes Clinic, Leibniz Institute at the Heinrich-Heine University, Auf ´m Hennekamp 65, 40225 Dusseldorf, Germany

More Information

Responsible Party:ERGOMED ( Bernd Knau )
Study ID Numbers:TRO19622 CLEQ 1104-1, EudraCT Number: 2006-004545-42
First Received:June 22, 2007
Last Updated:May 16, 2008
ClinicalTrials.gov Identifier:NCT00496457 [history]
Health Authority:Germany: Federal Institute for Drugs and Medical Devices; Germany: Ethics Commission; Serbia and Montenegro: Agency for Drugs and Medicinal Devices; Serbia: Local Ethic Committees; Croatia: Ministry of Health and Social Care; Latvia: State Agency of Medicines; Poland: Ministry of Health

Keywords provided by Trophos:
Diabetic Neuropathy
Painful Peripheral Diabetic Neuropathy
TRO19622
Trophos

Study placed in the following topic categories:
Neuromuscular Diseases
Diabetic Neuropathies
Peripheral Nervous System Diseases
Diabetes Mellitus
Endocrine System Diseases
Pain
Endocrinopathy
Diabetes Complications