Chronic low back pain MedDRA version: 17.0 Level: LLT Classification code 10024891 Term: Low back pain System Organ Class: 100000004859
Conditions
Interventions
Product Name: 15/30 SER-LAM
Pharmaceutical Form: Tablet
INN or Proposed INN: LAMOTRIGINE
Other descriptive name: LAMOTRIGINE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration
Sponsors
MEDITOP Gyógyszeripari Kft
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written and signed patient information leaflet and informed consent form, obtained prior to starting any study related protocol-specific procedures. 2. Age between 18 and 75 years (inclusive both males and females). 3. 18 kg/m2 = BMI = 35 kg/m2 (and the minimal body weight is 40 kg) 4. Chronic low back pain (as primary painful condition) with presence of pain restricted to lower back or radiated to limb on most days for at least > 3 months. 5. The average spontaneous pain severity score is =4 measuring on an 11-point numeric pain intensity rating scale (BPI) by the patient during the period of 1 week prior to the screening and enrollment. 6. For women of childbearing potential, agreement to use highly effective non-hormonal form of contraception or two effective forms of hormonal/non-hormonal contraception by the patient and/or partner. Contraception use must continue for the duration of study treatment and for at least 2 weeks after the last dose of study treatment. 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 192 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 192
Exclusion criteria
Exclusion criteria: 1. Current uncontrolled hypertension (systolic > 160 mmHg and/or diastolic > 100 mmHg). 2. If QTc > 450 msec. 3. If patient had a surgery in the low back region within 3 months prior to screening. 4. If surgery is indicated for the chronic low back pain. 5. Other reasons of low back pain (abscess, tumor etc.) revealed by neuroimaging. Result of MRI scan performed 3 months prior to randomization is acceptable. 6. Current (i.e. within 3 month prior to screening) spinal fracture, Grade 3 or Grade 4 spondylolisthesis, abscess or acute pathological conditions in the low back/abdominal region. 7. Evidence of any other disease, metabolic or psychological dysfunction, physical examination findings or clinical laboratory finding giving reasonable suspicion of a disease or condition that can significantly interfere with the low back pain or generate unresolved considerations in its differential. 8. Significant cardiovascular history within the past 6 months up to screening defined as: myocardial infarction, coronary angioplasty or bypass graft(s), valvular disease or repair, unstable angina pectoris, transient ischemic attack, or cerebrovascular accident 9. Patients suffering from epilepsy. 10. History of depression in the past 5 years or a current depressive episode. Patients with a score of =11 assessed by HADS depression sub-scale are not eligible. 11. Known hypersensitivity to sertraline or lamitrigine or any of the other ingredients of the study medications. 12. Known hypersensitivity to paracetamol. 13. Neurologic alteration of different origin which significantly affects the sensory or motoric functions (e.g. diabetic neuropathy). 14. Concurrent use of any type of medication having analgesic or muscle-relaxant effect, unless the medication is used regularly for at least 3 months in stable dose. Otherwise, any medication to relieve the pain (either systemic or local) or muscle spasms must have been discontinued for a period of at least 5 half-lives of the drug prior to the enrolment and are not allowed during the whole study period. 15. Concomitant use of monoamine-oxidase inhibitors, including the selective MAOI selegiline, the reversible MAOI moclobemide and reversible non-selective MAO inhibitor linezolid. 16. Concomitant use of pimozide, valproate, tramadol or any serotonergic drugs such as, sumatriptan. 17. Concomitant use of other analgesic methods, unless it is in a regular manner within 2 months prior to randomization (massage, physiotherapy, bath, etc.). 18. Inadequate organ functions, evidenced by laboratory results within 7 days prior to randomization. 19. History of drug or alcohol abuse within the past 2 years or current chronic or intermittent users of illicit drugs. 20. Lactating or pregnant women or women of child-bearing potential without appropriate contraceptive treatment. 21. Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the study or to cooperate at the necessary level. 22. The patient, planned to be enrolled, is an employee of any involved study investigator or any involved institution including the study sponsor 23. Evidence of an uncooperative attitude. 24. Participation in another clinical trial with any investigational drug or device within 1 month or 5 x half-life of the investigational drug prior to study screening of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether the combination of sertraline and lamotrigine, when administered to subjects with low back pain is effective in pain relief.;Secondary Objective: To determine the safety profile of the combination compared with placebo by assessment of: - Adverse Event (AEs) (including serious adverse events (SAEs) - Laboratory values - Electrocardiogram (ECG) - Vital signs - Body weight - Physical examination;Primary end point(s): Change in pain severity, assessed by using average pain ratings on an 11-point numerical rating scale from the baseline to the end of treatment (Brief Pain Inventory). ;Timepoint(s) of evaluation of this end point: Assessment of Brief Pain Inventory scale will be performed during screening, baseline, week 9 (after treatment of maximal dose) and week 11 (FU1, after dose reduction phase). Patients will rate their pain. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change in weekly mean pain scores of the nocturnal pain ratings (if the patient wakes up) from the baseline to the end of treatment (week 9) and to after reduction (week 11) measured by an 11-point numerical rating scale by the patients. 2. Change in Quality of life (EQ-5D) score assessment from baseline to the end of treatment (week 9) and to after reduction (week 11) 3. Change in Roland-Morris Disability Questionnaire (RMQ) from baseline to the end of treatment (week 9) and to after reduction (week 11) 4. Change in Athens Insomnia Scale from baseline to the end of treatment (week 9) and to after reduction (week 11) 5. Change in Hospital Anxiety and Depression Scale (HADS) between the following visits: screening, baseline, week 4, at the end of treatment (week 9) and after reduction (week 11) 6. Change in The Work Productivity and Activity Impairment (WPAI) from baseline to the end of treatment (week 9) and to after reduction (week 11) 7. Parameters of Brief Pain Inventory not covered in the primary endpoint from baseline to the end of treatment (week 9) and to after reduction (week 11) 8. Paracetamol intake during the treatment period;Timepoint(s) of evaluation of this end point: Patient will complet a diary for noctural pain during the whole study and for paracetamol intake. All secondary endpoint will be assessed during baseline visit. At week 4 the Hospital Anxiety and Depression Scale (HADS) assessment will be performed. At week 9 and week 11 the following assessments will be performed: - Change in Quality of life (EQ-5D) - Change in Roland-Morris Disability Questionnaire (RMQ) - Change in Athens Insomnia Scale - Change in Hospital Anxiety and Depression Scale (HADS) - Change in The Work Productivity and Activity Impairment (WPAI) - Parameters of Brief Pain Inventory not covered in the primary endpoint | — |
Countries
Hungary
Contacts
Public ContactGeneral Manager
CPS CORTEX Kft
Outcome results
None listed