Clinical trial NCT00414349 (phase 3, status: completed)
Conditions: neuropathic pain
ICD codes: E85.1, E85.0, N31.0, N31.1, N31.2, E10.610, E11.610
Drugs: topical analgesic, oral intake, topical analgesic
SMILES: OCCN(CCO)CCO.OC(=O)C1=CC=CC=C1O, OCCN(CCO)CCO.OC(=O)C1=CC=CC=C1O
Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects with >= 18 years of age

          -  Intact skin in the area of topical treatment

          -  Creatinine clearance CLCR >= 30 mL/min

          -  NRS-3 > 4 (recalled average pain intensity during the last 3 days)

        Subjects with DPN

          -  Controlled, treated type 1 or 2 diabetes mellitus with glycosylated hemoglobin
             (Hba1c)<= 11%

          -  Painful, distal symmetrical, sensomotor polyneuropathy of the lower extremities for >=
             3 months (below the knees on both extremities) with at least 2 of the following
             symptoms present: burning, sensation, tingling or prickling, numbness from time to
             time, painful heat or cold sensation (e.g. warm or cold water)

        Subjects with PHN

          -  Subjects with PHN and neuropathic pain present for >= 3 months after healing of the
             herpes zoster skin rash.

          -  Without neurolytic neurosurgical therapy for their condition.

        Exclusion Criteria:

        General

          -  Evidence or history of alcohol, medication or drug abuse and/or dependency in the past
             2 years, unstable psychological personality requiring intermittent or permanent
             treatment.

          -  Psychiatric illness (subjects with well-controlled depression or anxiety disorder may
             participate if they are not taking any of the prohibited medications defined (below),
             epilepsy or suicide risk.

          -  Pregnant or breastfeeding women

          -  Women of childbearing potential who are sexually active without satisfactory
             contraception for at least 28 days prior to enrollment, during the trial, and until 28
             days after the follow-up visit.

          -  Subjects with severe cardiac impairment e.g. NYHA class > 3, myocardial infarction
             less than 6 months prior to enrollment, and/or unstable angina pectoris.

          -  Subjects with severe hepatic disorder and/or AST or ALT >= 3x the upper limit of
             normal.

          -  Subjects with known or suspected severe renal failure (CLCR < 30 mL/min).

          -  Anticipated need for surgery during the trial, requiring at least regional or general
             anesthesia.

          -  Subjects who are undergoing active treatment for cancer, are known to be infected with
             HIV or being acutely and intensively immunosuppressed following transplantation.

          -  Participation in another trial of investigational medicinal products or devices
             parallel to or less than 1 month before entry into the trial, or previous
             participation in this trial.

        Trial specific:

          -  Any concomitant use of drugs for the treatment of neuropathic pain or commonly used
             for the treatment of neuropathic pain.

          -  Use of transcutaneous electrical nerve stimulations (TENS) after enrollment.

          -  CLCR < 30 mL/min

          -  Evidence of another cause for pain in the area of neuropathic pain such as lumbar
             radiculopathy, surgery trauma, restless legs syndrome, if this coud confound the
             assessment or self-evaluation of the neuropathic pain.

          -  Presence of other severe pain that could confound the assessment or self-evaluation of
             the neuropathic pain.

          -  History of malignancy within the past 5 years (with the exception of basal cell
             carcinoma).

        Subjects with PHN

          -  Active herpes zoster lesion or dermatitis of any origin at the affected site with PHN.

          -  Subjects who had neurological ablation by block or neurosurgical intervention for
             control of pain in PHN.

        Subjects with DPN

          -  No palpable pulse of the arteria dorsalis pedis in both feet.

          -  Clinical signs for venous insufficiency and/or postthrombotic syndrome Sage III/IV
             (i.e. extensive varicoses)

          -  Ulcers on the lower extremities.