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

This study has been completed.
Sponsor:
Collaborator:
Ergomed GmbH
Information provided by:
Trophos
ClinicalTrials.gov Identifier:
NCT00496457
First received: June 22, 2007
Last updated: January 26, 2009
Last verified: January 2009
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Multicenter Study With 500 mg QD of TRO19622 Versus Placebo in Patients With Painful Peripheral Diabetic Neuropathy

Resource links provided by NLM:


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
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
TRO19622
Drug: Experimental
Capsules of TRO19622 (125 mg)- Once a day before noon meal during 6 weeks
Placebo Comparator: 2 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≥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 (≤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.≥ 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Croatia
Univerity Hospital OSIJEK, Department for Diabetes and Endocrinology, J.Huttlera 4
Osijek, Croatia, 31 000
Genaral Hospital "Josip Bencevic", Internal Medicine Department-Unit for Diabetes, Andrije Stampara 42
Slavonski Brod, Croatia, 35 000
General Hospital Varazdin, Internal Medicine Department-Unit for Diabetes, Ivana Mestrovica bb
Varazdin, Croatia, 42 000
University Hospital "Dubrava", University Department for Internal Medicine, Institut for Diabetes, Endocrinology and Metabolic diseases, Avenija Gojka Suska 6
Zagreb, Croatia, 10 000
Germany
Diabetes Zentrum Mergentheim - Theodor-Klotzbücher-Straße 12
Bad Mergentheim, Germany, 97980
Diabetologische Schwerpunktpraxis - Wilhelminenstr. 22
Dinslaken-Bruch, Germany, 46537
Deutsches Diabetes Center, Institut für Klinische Diabetologie, Leibniz-Zentrum an der Heinrich-Heine Universität - Auf'm Hennekamp 65
Duesseldorf, Germany, 40225
Klinikum Region Hannover GmbH - Klinikum Hannover Nordstadt - Diabetes Schwerpunktklinik -Medizinische Klinik - Haltenhoffstr. 41
Hannover, Germany, 30167
Universitätsklinikum Heidelberg - Abteilung Innere Medizin I und klinische Chemie - Im Neuenheimer Feld 410
Heidelberg, Germany, 69120
Pro scientia med - Osterweide 10
Lübeck, Germany, 23562
IKFE GmbH - Institut für klinische Forschung und Entwicklung - Parcusstr. 8
Mainz, Germany, 55116
Diabetes Schwerpunktpraxis - Gesundheitszentrum Potsdam GmbH - Hebbelstr. 1A
Potsdam, Germany, 14467
Diabetes Schwerpunktpraxis - Gesundheitszentrum Potsdam GmbH, Hebbelstr. 1A
Potsdam, Germany, 14467
Sophien- und Hufeland-Klinikum gGmbH - Klinik für Neurologie und Klinische Neurophysiologie - Henry-van-de-Velde-Str. 2
Weimar, Germany, 99425
Latvia
Daugavpils Regional Hospital - Vasarnicu street 20
Daugavpils, Latvia, LV-5420
Zemgale's Diabetes Centre SIA - Zemgales boulevard 15
Jelgava, Latvia, LV-3000
Doctor's Practice in Endocrinology - Meža prospekts 9, 2nd floor, 41.kabinets
Ogre, Latvia, LV-5001
Clinical Research Centre "Riga" - Katrinas dambis 16
Riga, Latvia, LV-1045
Talsu Hospital - Rugena street 7
Talsi, Latvia, LV-3201
Poland
NZOZ Specjalistyczny Ośrodek, Internistyczno-Diabetologiczny, ul Zamenhofa 10/20
Białystok, Poland, 15-435
Centrum Neurologii Klinicznej - Ul. Dwernickiego 8
Kraków, Poland, 31-530
NZOZ MEDICA, ul. Jutrzenki 4
Lublin, Poland, 20-538
NZOZ Special-Med. Ul. Weteranów 46
Lublin, Poland, 20-044
NZOZ Beta-Med., Plac Wolności 17
Rzeszów, Poland, 35-073
Adamiec Rajmund Gabinet Lekarski, ul. Żelazna 34
Wrocław, Poland, 53-428
Serbia
Centre of Neurology, Clinical Hospital Centre "Dr Dragisa Misovic"
Belgrade, Serbia, 11000
Clinic for Neurology and Psychiatry, Clinical Hospital Centre "Zvezdara"
Belgrade, Serbia, 11000
Institute for Endocrinology, Clinical Centre Serbia
Belgrade, Serbia, 11000
Neurology Clinic, Military Medical Academy
Belgrade, Serbia, 11000
Neurology Department, Clinical Hospital Zemun
Belgrade, Serbia, 11000
Center for Neurology, Clinical Centre "Kragujevac"
Kragujevac, Serbia, 34000
Sponsors and Collaborators
Trophos
Ergomed GmbH
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

No publications provided

Responsible Party: Bernd Knau, ERGOMED
ClinicalTrials.gov Identifier: NCT00496457     History of Changes
Other Study ID Numbers: TRO19622 CLEQ 1104-1, EudraCT Number: 2006-004545-42
Study First Received: June 22, 2007
Last Updated: January 26, 2009
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

Additional relevant MeSH terms:
Diabetic Neuropathies
Peripheral Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Nervous System Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on November 25, 2014