A double-blind, randomized, multi-center study with 500 mg QD of TRO19622 versus placebo in patients with painful peripheral diabetic neuropathy
- Conditions
- Painful peripheral diabetic neuropathyMedDRA version: 8.1Level: LLTClassification code 10012680Term: Diabetic neuropathy
- Registration Number
- EUCTR2006-004545-42-DE
- Lead Sponsor
- TROPHOS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 180
1.Be a male >18 years or a post-menopausal female (>60 years of age and at least 1 year of amenorrhea).
2.Have painful diabetic neuropathy of >6 months duration and have had a documented response to their neuropathic pain treatment (if not pain treatment naive).
3.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.
4.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.
5.Have scored >2 points on the Michigan Neuropathy Screening Instrument (MNSI), part B-physical assessment by health professional.
6.Have a normal electrocardiogram (ECG)
The following inclusion criteria should be ascertained at the baseline visit:
7.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.
8.Have stopped current pain medication at least 14 days prior to the Baseline Visit (except rescue medication).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1.Be pregnant female, lactating female, or female of child bearing potential (=60 years of age).
2.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).
3.Have other neurological diseases that may produce weakness, sensory loss, or autonomic symptoms, or laboratory test abnormality.
4.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 3 drugs.
5.Have a current medication of lipid lowering agents other than statins.
6.Have a body mass index (BMI) >40 kg/m2 (obesity grade III).
7.Had any surgery within the previous 2 months.
8.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).
9.Have a recent history (within the previous 6 months) or current evidence of alcohol or drug abuse.
10.Have concurrent unstable disease involving any system (eg, advanced carcinoma, acute myocardial infarction, renal failure, or any other condition that in the opinion of the Investigator would make the patient unsuitable for study participation).
11.Participated in any other investigational drug or therapy study within the previous 3 months.
12.Changed or interrupted current well-tolerated medication during the previous 3 months.
13.Lack of ability or willingness to give informed consent.
14.Be possibly dependent on the Investigator or the Sponsor (eg, including, but not limited to, affiliated employee).
15.Have hemostasis disorders or a current treatment of anticoagulants.
16.Have non-adequate renal and/or hepatic function as follows:
•Renal – blood creatinine >1.5 × upper limit of normal (ULN)
•Hepatic – liver enzymes (ALT and AST) >2 × ULN
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method