Phase 2 trial, conducted in more than one site, in which no one knows the treatment assigned to the patient to evaluate the effect against pain and the safety of the study drug, DFL24412, respect a control drug (Ketoprofen Lysine Salt), in patient with chronic low back pai
- Conditions
- Chronic Low Back PainMedDRA version: 21.0Level: LLTClassification code 10052430Term: Chronic lumbagoSystem Organ Class: 100000004859Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2021-001629-38-ES
- Lead Sponsor
- Dompè Farmaceutici S.p.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 150
1. Provide written informed consent before the initiation of any study-specific procedures
2. Must be 18-65 years of age at the time of signing the Informed Consent Form (ICF)
3. Have a normal physical examination, 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
4. Diagnosis of persistent nonspecific chronic low back pain (CLBP, pain localised below the costal margin and above the inferior gluteal folds with no known specific pathology, persisting for at least 3 months), with no substantial recent change in pain severity or clinical management
5. Documented nociceptive and neuropathic components (DN4 >/= 4 for neuropatic component)
6. Report at least moderate pain (NRS>/= 4) before randomization
7. 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
8. If a female with childbearing potential, have a negative serum ß-human chorionic gonadotropin (ß-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 theirfemale 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.
9. Have a negative COVID-19 antigen rapid test or have received vaccination for COVID-19
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 140
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 10
1. History of major thoraco-abdominal or low back surgery in the last 3 months
2. CLBP due to malignancy, fibromyalgia,ochronosis, recent trauma, infection, juvenile scoliosis or congenital malformation
3. Previous diagnosis of psychosis, bipolar disorder, schizoaffective disorder, major depressive disorder or neurological disorder
4. CLPB management requiring opiod or surgery
5. Any concomitant use of antidepressants and/or anticonvulsants, opioids, nonsteroidal anti-inflammatory drugs, muscle relaxants, and/or any other prohibited medication during the trial or being anticipated by the investigator to be required
6. 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
7. History of drug and/or alcohol abuse or dependence, excluding nicotine and caffeine
8. 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)
9. Have serum creatinine level higher than 1.6mg/dL or creatinine clearance <60, or had renal transplantation or receiving renal dialysis
10. 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
11. History of bronchial asthma, peptic ulcer, gastrointestinal bleeding, ulceration or perforation
12. Crohn’s disease or ulcerative colitis
13. 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)
14. 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
15. Female patients who meet the following criteria: Pregnant, breast-feeding, and/or planning to become pregnant and/or breast-feed during the study
16. 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 Visit1
17. Be an employee or a relative of an employee of the investigational study center
18. 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
19. Unable or unlikely to comply with the study protocol, to fulfill eDiary and questionnaires appropriately or unsuitable for any other reason, as judged by the PI
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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 2;Secondary Objective: • To further evaluate the analgesic efficacy of DFL24412 80 mg-34 mg and DFL24412 40 mg-17 mg in chronic low back pain compared to KLS 80 mg.<br>• To assess the efficacy of DFL24412 compared to KLS on neuropathic component in chronic low back pain.<br>• To assess the effect of DFL24412 compared to KLS on quality of life, Patient Global impression of Change and work and mental impact.;Primary end point(s): Change From Baseline in Average Daily Low Back Pain (LBP) intensity as Measured by an 11-point Numeric Rating Scale (NRS) at Week 2;Timepoint(s) of evaluation of this end point: Time Frame: Baseline, Week 2
- Secondary Outcome Measures
Name Time Method