Efficacy and Tolerability of AP707 in Patients with chronic Pain due to Diabetic Polyneuropathy

Ki vehet részt

• Signed and dated informed consent form
• Patients with chronic pain due to diabetic polyneuropathy since at least 3 months
• Female and male patients (≥ 18 years)
• Patients with more than 1 year life expectancy
• Patients with optimized sCPT on study entry as defined in section 3.1.1 and section 3.1.3 of the study protocol
• Willingness of study patients of both sexes to use reliable contraception during study participation and for three months after taking the last study medication
• Good command of German language, in order to understand questionnaires in German
• Current moderate to severe pain with pain intensity ≥ 5 on Numeric Rating Scale (NRS, 0 - 10) and thus an existing need for further pain therapy
• Completed QUISS (Quantification Inventory for Somatoform Syndromes) questionnaire with 45 or less score points

Ki nem vehet részt

• Medical history of hypersensitivity or intolerance to the investigational product or its ingredients or to ingredients of similar chemical structure
• Participation in another clinical trial within the last four weeks prior to inclusion
• Known history of severe cardiovascular disease
• Known history of or acute mental illness such as severe depression, psychosis, bipolar disorder, mania, anxiety, or obsessive-compulsive disorder
• Known history of addictive disease (e.g., alcohol, medication, drug addiction)
• Other medical conditions that do not allow the trial subject to appraise the nature, scope, and potential consequences of the clinical trial
• Active malignant tumor disease, tumor pain, or other dominant severe pain other than that of the study indication
• Known history of severe liver or kidney diseases
• Laboratory liver values: Alanine aminotransferase (ALT, GPT) > 3 x ULN (Upper Limit of Normal range), Aspartate aminotransferase (AST, GOT) > 3 x ULN, Alkaline phosphatase (AP) > 2.5 x ULN, and for bilirubin > 1.5 x ULN
• Laboratory renal value: Serum creatinine > 1.5 ULN
• Answered during Screening less than 12 times of 18 the pain intensity (NRS) inquiry
• Known intolerance to cannabinoids or cannabis products
• Pregnant or nursing women (as excluded by pregnancy testing at visit 1 for women of childbearing potential)
• Indications that the trial subject is unlikely to comply with the study protocol (e.g., unwillingness to cooperate)
• Known use of medicinal cannabis products within the last 8 weeks