Extract Study by Cannamedical about Pain Ease

Recruiting

Conditions: chronic pain

Registration Number: DRKS00026906

Lead Sponsor: Cannamedical Pharma GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 500

Inclusion Criteria

1. Age = 18 years
2. Presence of chronic pain
3. Previous pain therapies have not been successful due to side effects, insufficient dose, due to side effects, drug interactions or pre-existing conditions, allergic reactions
4. No previous therapy with the Cannamedical-Extract
5. Prescription of medicinal cannabis is indicated
6. Patients who—after having been informed by their physician—have signed the consent and privacy policy.

Exclusion Criteria

1. Existing recreational cannabis use in the last 6 months
2. Existing recreational drug use in the last 6 months
3. Presence of schizophrenia, psychosis, or other psychiatric diseases
4. Known allergies to ingredients or carriers.
5. Presence of pregnancy and lactation and women who are planning to become pregnant during
6. Simultaneous participation in another study
7. Patients who are not capable of giving consent
8. Imprisoned or under-age patients
9. Persons who do not speak German

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effect of Cannamedical® Hybrid cannabis extract on average pain intensity measured by 11-item Numerical Rating Scale (NRS). The NRS values of V1 (baseline study) are compared with those of the subsequent visits (V2-V4).

Secondary Outcome Measures

Name	Time	Method
1. Quality of life, measured by the BPI-SF (general activity, mood, ability to walk, normal work, relationship with others, sleep, enjoyment of life)<br>2. Quality of life, measured by the SF-12 (vitality, social contacts, emotions in coping with everyday life, well-being).<br>3. Agility, self-care, general activities, measured by the EQ-5D-3L<br>4. Duration and quality of sleep, measured by means of the MOS-SS <br>5. Physician satisfaction with therapy<br>6. Patient satisfaction with therapy<br>7. Number of sick days so far