Clinical trial NCT00496457 (phase 2, status: completed)
Conditions: diabetic neuropathy
ICD codes: E10.40, E11.40, E13.40, E10.43, E11.43, E13.43, E08.40
Drugs: experimental, placebo comparator
SMILES: C#CC1=CC=CC(NC2=NC=NC3=CC4=C(OCCOCCOCCO4)C=C23)=C1, [Na+].[Cl-]
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.

        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.