M54 F45.41 R52 M53 M79
Conditions
Interventions
Group 1: Patients with chronic pain will be treated over a period of 14 weeks with CannaXan 771. They will be asked daily about their pain intensity on a scale of 0-10 and about any concomitant medica
Sponsors
CannaXan GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Existing patient informed consent obtained after providing information 2. Patient with a serious illness and resulting chronic pain that has not been sufficiently re-lieved by existing treatment options (cf. § 31 para. 6 SGB V) 3. Moderate to severe pain: = 5 on the NRS scale (0 – 10)
Exclusion criteria
Exclusion criteria: 1. Known history of hypersensitivity or intolerance to CannaXan 771 or its ingredients, or to ingredients of similar chemical structure 2. Concurrent use of other cannabis products 3. Existing substance dependence disorder (e.g., alcohol, medication, drug dependence) 4. Pregnant or breastfeeding women 5. Psychological illness, current or past, that precludes participation in the study 6. Acute severe somatic diseases (gastrointestinal diseases, common cold) 7. Severe cardiovascular diseases 8. Chronic Hepatitis C or other liver or kidney disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this prospective non-interventional study is to evaluate the acceptance and tolerability of CannaXan 771 treatment in chronic pain patients in clinical practice. To clearly evaluate the acceptance of the treatment, the following parameters are defined and recorded as 'acceptance criteria': • Documentation of pain reduction using the 11-point Numeric Rating Scale (NRS) throughout the therapy with CannaXan 771. • Improvement in health-related quality of life using the SF-12 (Short-Form Health Survey) questionnaire. • Improvement in sleep quality using the RIS (Regensburg Insomnia Score) qestionnaire. The tolerability of the treatment is evaluated by documenting the following parameters: • Occurrence of side effects during the therapy with CannaXan 771 • Optionally, liver function tests (ALT, AST, AP, Bilirubin) if they are routinely performed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives of this prospective NIS include the documentation of the following parameters: • Reduction of analgesic concomitant medication (dose, type, and combination) • Dose of the compounded medication CannaXan 771 | — |
Countries
Germany
Contacts
Public ContactStefan Lorenzl
Krankenhaus Agatharied/Neurologie
Outcome results
None listed