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

NCT00496457 | Completed Phase 2

• 3 other identifiers: WN29860EudraCT Number: 2006-004545-42TRO19622 CLEQ 1104-1
• Study Type: interventional
• Target: 159
• Locations: 5 countries
• Sites: 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.

Conditions

Diabetic Neuropathy

Keywords

Diabetic Neuropathy; Painful Peripheral Diabetic Neuropathy; TRO19622; Trophos

Outcome Measures

Primary Outcomes (1)

• Effect of TRO19622 versus Placebo on the mean 24h neuropathic pain score on the Likert numerical rating scale.

  During the last 7 days of the 6-week treatment period

Secondary Outcomes (3)

• 24h Pain time course

  Duration of study (within 11weeks after screening)

• Analysis for treatment effects: SF-MPQ, SF-BPI, SF36, POMS, Global Impression of Change (Patient / Investigator)

  Within 6 weeks of treatment

• Adverse events

  During the course of the study.

Study Arms (2)

1

EXPERIMENTAL

TRO19622

Drug: Experimental

2

PLACEBO COMPARATOR

Drug: Placebo comparator

Interventions

Experimental DRUG

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

1

Placebo comparator DRUG

4 Capsules of PBO per day before noon meal

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Hoffmann-La Roche: lead
• Ergomed GmbH: collaborator

Study Sites (31)

Univerity Hospital OSIJEK, Department for Diabetes and Endocrinology, J.Huttlera 4

Osijek, 31 000, Croatia

Location

Genaral Hospital "Josip Bencevic", Internal Medicine Department-Unit for Diabetes, Andrije Stampara 42

Slavonski Brod, 35 000, Croatia

Location

General Hospital Varazdin, Internal Medicine Department-Unit for Diabetes, Ivana Mestrovica bb

Varaždin, 42 000, Croatia

Location

University Hospital "Dubrava", University Department for Internal Medicine, Institut for Diabetes, Endocrinology and Metabolic diseases, Avenija Gojka Suska 6

Zagreb, 10 000, Croatia

Location

Diabetes Zentrum Mergentheim - Theodor-Klotzbücher-Straße 12

Bad Mergentheim, 97980, Germany

Location

Diabetologische Schwerpunktpraxis - Wilhelminenstr. 22

Dinslaken-Bruch, 46537, Germany

Location

Deutsches Diabetes Center, Institut für Klinische Diabetologie, Leibniz-Zentrum an der Heinrich-Heine Universität - Auf'm Hennekamp 65

Düsseldorf, 40225, Germany

Location

Klinikum Region Hannover GmbH - Klinikum Hannover Nordstadt - Diabetes Schwerpunktklinik -Medizinische Klinik - Haltenhoffstr. 41

Hanover, 30167, Germany

Location

Universitätsklinikum Heidelberg - Abteilung Innere Medizin I und klinische Chemie - Im Neuenheimer Feld 410

Heidelberg, 69120, Germany

Location

Pro scientia med - Osterweide 10

Lübeck, 23562, Germany

Location

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

Mainz, 55116, Germany

Location

Diabetes Schwerpunktpraxis - Gesundheitszentrum Potsdam GmbH - Hebbelstr. 1A

Potsdam, 14467, Germany

Location

Diabetes Schwerpunktpraxis - Gesundheitszentrum Potsdam GmbH, Hebbelstr. 1A

Potsdam, 14467, Germany

Location

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

Weimar, 99425, Germany

Location

Daugavpils Regional Hospital - Vasarnicu street 20

Daugavpils, LV-5420, Latvia

Location

Zemgale's Diabetes Centre SIA - Zemgales boulevard 15

Jelgava, LV-3000, Latvia

Location

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

Ogre, LV-5001, Latvia

Location

Clinical Research Centre "Riga" - Katrinas dambis 16

Riga, LV-1045, Latvia

Location

Talsu Hospital - Rugena street 7

Talsi, LV-3201, Latvia

Location

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

Bialystok, 15-435, Poland

Location

Centrum Neurologii Klinicznej - Ul. Dwernickiego 8

Krakow, 31-530, Poland

Location

NZOZ Special-Med. Ul. Weteranów 46

Lublin, 20-044, Poland

Location

NZOZ MEDICA, ul. Jutrzenki 4

Lublin, 20-538, Poland

Location

NZOZ Beta-Med., Plac Wolności 17

Rzeszów, 35-073, Poland

Location

Adamiec Rajmund Gabinet Lekarski, ul. Żelazna 34

Wroclaw, 53-428, Poland

Location

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

Belgrade, 11000, Serbia

Location

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

Belgrade, 11000, Serbia

Location

Institute for Endocrinology, Clinical Centre Serbia

Belgrade, 11000, Serbia

Location

Neurology Clinic, Military Medical Academy

Belgrade, 11000, Serbia

Location

Neurology Department, Clinical Hospital Zemun

Belgrade, 11000, Serbia

Location

Center for Neurology, Clinical Centre "Kragujevac"

Kragujevac, 34000, Serbia

Location

MeSH Terms

Conditions

Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Jean-Louis Abitbol, MD

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

  STUDY CHAIR

• Dan Ziegler, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2007
• First Posted: July 4, 2007
• Study Start: May 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: November 22, 2016

Record last verified: 2016-11

Locations

CR (4); LA (5); PL (6); SE (6); DE (10)