Chronic Low Back Pain MedDRA version: 21.0 Level: LLT Classification code 10052430 Term: Chronic lumbago System Organ Class: 100000004859
Conditions
Interventions
Product Name: Co-crystal of ketoprofen, lysine and gabapentin
Product Code: DFL24412
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: KETOPROFEN LYSINE SALT
CAS Number: 57469-78-0
Current Spons
Sponsors
Dompè Farmaceutici S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. • To assess the efficacy of DFL24412 compared to KLS on neuropathic component in chronic low back pain. • 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change From Baseline in Average Daily LBP Intesity as Measured by an 11-point Numeric Rating Scale (NRS) at Week 1 2. Change From Baseline in Average Daily Low Back Pain (LBP) Intensity as Measured by an 11-point Numeric Rating Scale (NRS) at the follow-up visit 3. Change from baseline in Neuropathic Pain Symptom Inventory (NPSI) score at week 2 4. Change from baseline in Douleur Neuropathique en 4 Questions (DN4) score at week 2 5. Change from baseline in Douleur Neuropathique en 4 Questions (DN4) score at the follow-up visit 6. Number of Participants Withdrawn Due to Lack of Efficacy 7. Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 2 8. Change from Baseline in Hospital Anxiety and Depression Scale (HADS) total score at Week 2 9. Patient Global Impression of Change (PGI-C) Score 10. Change From Baseline in European Quality of Life Questionnaire-5 Dimension-5 Level (EQ-5D-5L) to Week 2 11. Change From Baseline in Work Productivity and Activity Impairment (WPAI) Instrument to Week 2 12. Number of rescue interventions;Timepoint(s) of evaluation of this end point: 1. Time Frame: Baseline, Week 1 2. Time Frame: Baseline, Day 28 3. Time Frame: Baseline, Week 2 4. Time Frame: Baseline, Week 2 5. Time Frame: Baseline, Day 28 6. Time Frame: Baseline, Week 2 7. Time Frame: Baseline, Week 2 8. Time Frame: Baseline, Week 2 9. Time Frame: Week 2 10. Time Frame: Baseline, Week 2 11. Time Frame: Baseline, Week 2 12. Time Frame: week 2 | — |
Countries
Italy, Spain
Contacts
Public ContactClinical Operations
Dompè Farmaceutici S.p.A.
Outcome results
None listed