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Efficacy and Tolerability of AP707 in Patients with Chronic Back Pain
EU CTIS ID: 2022-502151-54-00
What this study is testing
Evaluation of efficacy of AP707 as add-on treatment in patients with chronic back pain
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed and dated informed consent form
- Completed painDETECT questionnaire with 20 or more score points
- Patients with chronic back pain 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
You likely can't join if
- Medical history of hypersensitivity or intolerance to the investigational product or its ingredients or to ingredients of similar chemical structure
- 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)
- Answered during Screening less than 12 times of 18 the pain intensity (NRS) inquiry
- 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, Bilirubin > 1.5 x ULN
See the full eligibility criteria
- Signed and dated informed consent form
- Completed painDETECT questionnaire with 20 or more score points
- Patients with chronic back pain 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
- Medical history of hypersensitivity or intolerance to the investigational product or its ingredients or to ingredients of similar chemical structure
- 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)
- Answered during Screening less than 12 times of 18 the pain intensity (NRS) inquiry
- 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, Bilirubin > 1.5 x ULN
- Laboratory renal value: Serum creatinine > 1.5 ULN
- Known intolerance to cannabinoids or cannabis products
- Participation in another clinical trial within the last four weeks prior to inclusion
- Pregnant or nursing women (as excluded by pregnancy testing at visit 1 for women of childbearing potential)
- Other medical conditions that do not allow the trial subject to appraise the nature, scope, and potential consequences of the clinical trial
- 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.