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A phase 2, multicenter, randomized, double blind, active controlled, parallel group study assessing the analgesic effect and safety of two doses of DFL24412 in patients with chronic low back pain compared to Ketoprofen Lysine Salt (KLS)
EU CTIS ID: 2024-513940-27-00
What this study is testing
To evaluate the efficacy of DFL24412 80 mg-34 mg per os (p.o.) and DFL24412 40 mg-17 mg p.o. in chronic low back pain compared to KLS (80 mg) at week 1.
- Therapeutic exploratory (Phase II)
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
- Provide written informed consent before the initiation of any study-specific procedures
- Must be 18-65 years of age at the time of signing the Informed Consent Form (ICF)
- Have a normal physical examination (except features of CLBP as per IC 4, 5, and 6), vital signs, clinical laboratory test results, and electrocardiogram (ECG) results or abnormal results that are judged not clinically significant by the PI and documented as such in the eCRF
- Diagnosis of chronic low back pain (CLBP, pain localised below the costal margin and above the inferior gluteal folds with no known specific pathology, persisting/recurring for at least 3 months) with no substantial recent change in pain severity or clinical management, with or without lumbosacral radicular pain and/or radiculopathy
- Clinically documented nociceptive and neuropathic components ((‘probable neuropathic pain’ as per International Association for the Study of Pain, IASP)
- Report at least moderate pain (NRS ≥ 4) before randomization
You likely can't join if
- History of major thoraco-abdominal or low back surgery in the last 3 months
- Severe or unstable cardiovascular, hepatic, renal, metabolic, respiratory, or hematologic diseases, symptomatic peripheral vascular disease, hemorrhagic diathesis, haemolytic anemia, systemic immune-mediated and rheumatologic disorders, or other medical condition or psychiatric conditions that, in the opinion of investigator, would compromise participation or be likely to lead to hospitalization during the course of the study
- History of bronchial asthma, peptic ulcer, gastrointestinal bleeding, ulceration or perforation
- Crohn’s disease or ulcerative colitis
- Positive test for hepatitis B surface antigen (HBsAg), anti-hepatitis C antibody (antiHCV) or human immunodeficiency virus I and II antibodies (anti-HIV I/II)
- History of intolerance or hypersensitivity to: ketoprofen lysine salt or other drugs of the same class, gabapentin, rescue medications, component of the formulation; any history of severe drug allergy or hypersensitivity
See the full eligibility criteria
Who can join
- Provide written informed consent before the initiation of any study-specific procedures
- Must be 18-65 years of age at the time of signing the Informed Consent Form (ICF)
- Have a normal physical examination (except features of CLBP as per IC 4, 5, and 6), vital signs, clinical laboratory test results, and electrocardiogram (ECG) results or abnormal results that are judged not clinically significant by the PI and documented as such in the eCRF
- Diagnosis of chronic low back pain (CLBP, pain localised below the costal margin and above the inferior gluteal folds with no known specific pathology, persisting/recurring for at least 3 months) with no substantial recent change in pain severity or clinical management, with or without lumbosacral radicular pain and/or radiculopathy
- Clinically documented nociceptive and neuropathic components ((‘probable neuropathic pain’ as per International Association for the Study of Pain, IASP)
- Report at least moderate pain (NRS ≥ 4) before randomization
- If undergoing physical and/or exercise-based therapy for back pain, therapy must be stable at least three weeks prior to study and remain the same throughout study
- If a female with childbearing potential, have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test; Women of childbearing age and potential must be willing to use highly effective contraception during the study and for 3 months after the last study treatment dose. Male patients and their female partners of childbearing age and potential must be willing to use effective contraception during the study and for 3 months after the last study treatment dose. Highly effective methods of birth control are listed in Appendix 4 of Protocol KLG0121.
- Have a negative COVID-19 antigen rapid test or have received vaccination for COVID-19
What rules you out
- History of major thoraco-abdominal or low back surgery in the last 3 months
- Severe or unstable cardiovascular, hepatic, renal, metabolic, respiratory, or hematologic diseases, symptomatic peripheral vascular disease, hemorrhagic diathesis, haemolytic anemia, systemic immune-mediated and rheumatologic disorders, or other medical condition or psychiatric conditions that, in the opinion of investigator, would compromise participation or be likely to lead to hospitalization during the course of the study
- History of bronchial asthma, peptic ulcer, gastrointestinal bleeding, ulceration or perforation
- Crohn’s disease or ulcerative colitis
- Positive test for hepatitis B surface antigen (HBsAg), anti-hepatitis C antibody (antiHCV) or human immunodeficiency virus I and II antibodies (anti-HIV I/II)
- History of intolerance or hypersensitivity to: ketoprofen lysine salt or other drugs of the same class, gabapentin, rescue medications, component of the formulation; any history of severe drug allergy or hypersensitivity
- Female patients who meet the following criteria: Pregnant, breast-feeding, and/or planning to become pregnant and/or breast-feed during the study
- Treatment with any investigational product (IP) during the study and within the 3 months (or at least 5 half-lives, whichever is longer) prior to Visit 1
- Be an employee or a relative of an employee of the investigational study center
- Inability to speak and understand the local language sufficiently to understand the nature of the study, to provide written informed consent, and to allow the completion of all study assessments
- Unable or unlikely to comply with the study protocol, to fulfill eDiary/ paper Diary and questionnaires appropriately or unsuitable for any other reason, as judged by the PI
- CLBP due to malignancy, fibromyalgia, ochronosis, recent trauma, infection, juvenile scoliosis or congenital malformation
- Previous diagnosis of psychosis, bipolar disorder, schizoaffective disorder, major depressive disorder or neurological disorder
- CLBP management requiring opioids or surgery and interventional procedures planned in the following 3 months
- Any concomitant use of antidepressants, anticonvulsants, opioids, nonsteroidal anti-inflammatory drugs, muscle relaxants, and/or any other prohibited medication as listed in Appendix 6 of Protocol KLG0121 during the trial or being anticipated by the investigator to be required
- Any concurrent medical condition that, in the judgment of the PI, might interfere with the conduct of the study, confound the interpretation of the study results, or endanger the patient’s well-being
- History of drug and/or alcohol abuse or dependence, excluding nicotine and caffeine
- Have alanine aminotransferase or aspartate aminotransferase higher than 100 International Units per Liter (IU/L) or total bilirubin higher than 1.6 milligram per deciliter (mg/dL)
- Have serum creatinine level higher than 1.6 mg/dL or creatinine clearance < 60, or had renal transplantation or receiving renal dialysis
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.