CYANOCOBALAMIN; PHOSPHOLIPID FROM CEREBRAL CORTEX. for Chronic low back pain

Inclusion criteria

• {"criterion_text":"- Clinical diagnosis of chronic mechanical (mild, moderate degenerative process of disc and facet) chronic LBP, for at least 3 months but no more than 6 months, confirmed (thanks to instrumental analysis obtained within 9 months before the Screening visit) by CT or MRI. In case a MRI/CT performed in the previous 9 months is not available, the diagnosis should be confirmed by means of a MRI performed between Screening visit (Visit 1) and Baseline visit (Visit 2).\n- If female, patient must have a negative urine pregnancy test and use a highly effective form of contraception for a least one month prior to screening and throughout the study; or females must be surgically sterile, or postmenopausal as documented in medical history for at least one year. Highly effective birth control methods include: combined hormonal contraception (containing estrogen and progestogen) associated with inhibition of ovulation (oral, intravaginal, transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomised partner; sexual abstinence\n- Patients who did not use Tricortin 1000 in the past to treat LBP or other pathological conditions\n- A moderate to severe acute exacerbation of chronic LBP at study entry, defined as a score ≥4 and ≤8 rated on the NRS-11\n- Age greater than or equal to 40 and less than or equal to 70 years\n- Patient able to maintain a Diary during the study\n- Patient with a Body Mass Index (BMI) < 30 kg/m2\n- Discontinuation of any analgesic/NSAID therapy, opioids, corticosteroids, skeletal muscle relaxants and any other medication or non-pharmacological therapy (if it would interfere with the study assessments), with the exception of paracetamol, with no intent to resume during study\n- Patients who did not receive antidepressant medications and/or benzodiazepines for at least 60 days\n- Patient able to read and understand the language and content of the study material, understand the requirements for follow-up visits, is willing to provide information at the scheduled evaluations and is willing and able to comply with the study requirements\n- Patient has undergone the informed consent process and has signed an approved consent form"}

Exclusion criteria

• {"criterion_text":"- Patients suffering of chronic non-specific LBP\n- Patients who are not able to give informed consent\n- Patients who cannot commit to the entire duration of the study\n- Patients with back pain referred from a mechanical cause (except for mild, moderate degenerative process of disc and facet) non spinal source or back pain associated with another specific spinal cause\n- Patients who have a primary bone disease, cancer, infection (except for osteoporosis patients without fracture history)\n- Other conditions which may confound the interpretation of the study, such as rheumatoid arthritis, severe venous diseases, peripheral arterial diseases, transient ischemic attack, stroke, current symptoms of coronary artery disease\n- History of narcotic abuse at any time in the past and/or drug or alcohol abuse in the past year\n- Patients who have had a previous treatment with physical therapy for LBP in the last 4 weeks before the screening visit or are going through a course of physical therapy or chiropractic treatment at the time of planned enrolment\n- History of carcinoma\n- Progressive neurological deficit\n- Disturbed gait, saddle anaesthesia\n- Participation in another research study\n- Radicular syndromes of idiopatic, metabolic, toxic, infective, demyelinating or neoplastic aetiology\n- Patients with spondylolisthesis, spondylolysis or ankylosing spondylitis\n- Patients with scoliosis of 15° or more\n- Patients with inflammatory arthritis or severe degenerative process of disc and facet\n- Patients who have had prior spine surgery, including rhizotomy as like as, patients who are planning or have been advised to have spine surgery\n- Patients with any concomitant chronic disease(s) or condition(s) that may predispose them to a high probability of interfering with the completion of the follow-up of the study such as peptic ulcer, liver disease, severe coronary disease, renal disease, cancer, pregnancy, alcoholism, mental state, or other clinically significant condition\n- Patients with history of active or suspected oesophageal, gastric, pyloric channel, or duodenal ulceration or bleeding in the last 12 weeks before the screening visit\n- Patients requiring chronic use of analgesia for pain\n- Patients with known allergies or hypersensitivity or intolerance to Tricortin 1000, NSAIDs and/or paracetamol, and/or to active or inactive excipients of formulation\n- Patients in treatment with neuroleptics (antipsychotics)\n- History of epilepsy\n- Patients affected by diabetic neuropathy, multiple sclerosis or Amyotrophic Lateral Sclerosis\n- Any contraindications to either prone distraction or side posture manipulation\n- Any contraindications as reported in the Patient Information Leaflet of Tricortin 1000 or Diclofenac sodium medicated plaster\n- Patients who have an unstable psychiatric condition\n- Unexplained serious thoracic pain\n- Any recent trauma, which may raise the possibility of a fracture\n- Fever and unexplained weight loss\n- Bladder or bowel dysfunction\n- Females who are pregnant or breast-feeding"}

Primary endpoints

• {"endpoint_text":"- Mean change from baseline to Day 15 in NRS-11","definition_or_measurement_approach":"Change from baseline to Day 15 measured on the NRS-11 (Numeric Rating Scale 0-10) for pain."}

Secondary endpoints

• {"endpoint_text":"- LBP related disability improvement measured through the Oswestry Low Back Pain Disability Index (ODI), version 2.1a, at baseline visit and then in the following visits: V3-Day 7 and V4-Day 15.","definition_or_measurement_approach":"Oswestry Disability Index (ODI) version 2.1a measured at baseline, Day 7 (V3) and Day 15 (V4)."}
• {"endpoint_text":"- Clinical improvement evaluated at baseline visit and then at V3-Day 7 and V4-Day 15 through the following parameters: Range of Motion testing, Joint reflex changes (ROT), Lasegue’s test (passive straight leg raise), Femoral stretch test (Wasserman test), Dandy’s sign, Valleix’s points pressure","definition_or_measurement_approach":"Clinical assessments including range of motion, reflexes (ROT), Lasegue's test, femoral stretch test, Dandy's sign, and Valleix's points pressure at baseline, Day 7 and Day 15."}
• {"endpoint_text":"- PGA and CGI of the status of LBP evaluated at baseline visit and then in the following visits: V3-Day 7 and V4-Day 15","definition_or_measurement_approach":"Patient Global Assessment (PGA) and Clinical Global Impression (CGI) assessed at baseline, Day 7 and Day 15."}
• {"endpoint_text":"- Daily rescue medication required for pain relief","definition_or_measurement_approach":"Recording of daily use of rescue medication for pain relief during study period."}
• {"endpoint_text":"- Safety of daily intramuscular Tricortin 1000 injections and of twice daily diclofenac sodium medicated plaster applications evaluated by physical examination, vital signs and by tracking the number of patient withdrawals and their adverse events at each visit.","definition_or_measurement_approach":"Safety assessed by physical examination, vital signs, monitoring withdrawals and adverse events at each visit."}

Italy

Earliest CTIS Part Ii Submission Date

05-09-2024

Latest Decision Or Authorization Date

19-12-2025

Processing Time Days

470

Number Of Sites

7

Number Of Participants

300

Primary sponsor

Full Name

Fidia Farmaceutici S.p.A.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Italy

Third parties

• {"country":"Italy","full_name":"Lb Research S.r.l.","duties_or_roles":"Codes: 1,10,11,4,5,6,7","organisation_type":"Pharmaceutical company"}
• {"country":"Italy","full_name":"Nerpharma S.r.l.","duties_or_roles":"Code: 14","organisation_type":"Pharmaceutical company"}