Long Term Efficacy and Tolerability of AP707 in Patients With Chronic Back Pain

Launched by APURANO PHARMACEUTICALS GMBH · Oct 5, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called AP707 for people suffering from chronic back pain. The research aims to find out how effective and safe this treatment is over a long period. Participants will receive either AP707 or a placebo (a treatment with no active ingredients) for 14 weeks, in addition to their standard pain management. The researchers will monitor changes in pain levels, quality of life, and sleep to see how well the treatment works.

To be eligible for the trial, participants must be at least 18 years old, have had chronic back pain for at least three months, and experience moderate to severe pain. They should also be able to understand German well enough to complete questionnaires. It's important to note that certain medical conditions, such as severe heart or liver problems, or a history of substance abuse, may exclude someone from participating. Participants will have the opportunity to help advance research into better pain management while receiving careful monitoring throughout the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Signed and dated informed consent form
• • 2. Patients with chronic back pain since at least 3 months
• • 3. Female and male patients (\> 18 years)
• • 4. Patients with more than 1 year life expectancy
• • 5. Patients with optimized sCPT on study entry as defined in section 3.1.1 and section 3.1.3 of the study protocol
• • 6. Willingness of study patients of both sexes to use reliable contraception during study participation and for three months after taking the last study medication
• • 7. Good command of German language, in order to understand questionnaires in German
• • 8. 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
• • 9. Completed QUISS (Quantification Inventory for Somatoform Syndromes) questionnaire with 45 or less score points
• • 10. Completed painDETECT questionnaire with 20 or more score points
• Exclusion Criteria:
• • 1. Medical history of hypersensitivity or intolerance to the investigational product or its ingredients or to ingredients of similar chemical structure
• • 2. Known intolerance to cannabinoids or cannabis products.
• • 3. Participation in another clinical trial within the last four weeks prior to inclusion.
• • 4. Pregnant or nursing women (as excluded by pregnancy testing at visit 1).
• • 5. Other medical conditions that do not allow the trial subject to appraise the nature, scope, and potential consequences of the clinical trial
• • 6. Indications that the trial subject is unlikely to comply with the study protocol (e.g., unwillingness to cooperate)
• • 7. Known use of medicinal cannabis products within the last 8 weeks
• • 8. Active malignant tumor disease, tumor pain, or other dominant severe pain other than that of the study indication
• • 9. Known history of severe liver or kidney diseases
• • 10. Known history of severe cardiovascular disease
• • 11. Known history of or acute mental illness such as severe depression, psychosis, bipolar disorder, mania, anxiety, or obsessive-compulsive disorder
• • 12. Known history of addictive disease (e.g., alcohol, medication, drug addiction)
• • 13. Answered during Screening less than 12 times of 18 the pain intensity (NRS) inquiry
• • 14. 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
• • 15. Laboratory renal value: Serum creatinine \> 1.5 ULN