Low Back Pain. MedDRA version: 20.0 Level: LLT Classification code 10024988 Term: Lumbago System Organ Class: 100000004859
Conditions
Interventions
Product Name: IDN 5243
Product Code: IDN 5243
Pharmaceutical Form: Solution for injection
INN or Proposed INN: 3-glycosyl-3-O-demethylthiocolchicine derivative.
CAS Number: 810669-93-3
Current Sponsor
Sponsors
INDENA S.P.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female patients, - 18-70 years old inclusive,- Signed Informed consent obtained prior the inclusion in the trial, - A diagnosis of LBP equal to or greater than 50 mm on VAS with severe or moderate lumbar muscle spasm naïve or in relapsing condition, - Patients must have a medical history, physical and neurological examinations that support a clinical diagnosis of acute LBP that is felt down to the lower leg below the knee with the onset no longer than 30 days before Visit 1, - Patients must be appropriate candidates for treatment with study medication in the Investigator's clinical judgment, - Patients must be able to appropriately verbalize pain characteristics and to complete all protocol required measurements/assessments without assistance, - Patients must be medically stable on the basis of physical examination, medical history, vital signs, and clinical laboratory tests performed at screening. Are the trial subjects under 18? no Number of subjects for this age range: 1 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: - LPB of non-mechanical origin such as neoplasm, infection or inflammatory chronic disorder, - Serum creatinine level > 1.7 mg/dL or Urea > 17 mmol/l, - Severe to mild hepatic dysfunction, - Abnormal blood count, - Ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients, - History of anaphylaxis to drugs or allergic reactions in particular, history of hypersensitivity reactions (e.g. bronchospasm, rhinitis, urticaria) to drugs including to paracetamol, - Patients with diabetic neuropathy, post-herpetic neuralgia, osteoarthritis pain, fibromyalgia, - History of psychosis (e.g. schizophrenia or psychotic depression) or major depression (requiring treatment); diagnosis including dementia, anxiety, mental retardation; multiple sclerosis, Parkinson's Disease, Restless Legs Syndrome, - Significant kidney or liver disease, - History of gastrointestinal disorders, - Blood coagulation disorders, - Skin conditions affecting the site of application (e.g. eczema, weeping dermatitis), - Use of paracetamol and/or NSAIDs within 24 h before inclusion,- Use of topical medications applied to the painful region within 2 days before the inclusion; use of opioids within 7 days before the inclusion, - Use of corticosteroid drugs by any route of administration within 30 days before the inclusion, - Use of myorelaxant drugs within 3 days before the inclusion, - Pregnant or lactating women, or women of childbearing age not using a reliable method of contraception, or women of not child-bearing potential if not permanently sterilised or if not in post-menopausal status from at least two years, - History of back (cervical, thoracic or lumbosacral) pain as 50% of the time in the 1 year prior to the first visit, - History of any LBP episode, with the exception of the current acute LBP episode, within 3 months prior to the first visit that was greater than mild in pain intensity, or was associated with disability (e.g., loss of time from work, family, or activities of daily living), or necessitated the use of an opioid (narcotic) analgesic including tramadol, - Medical history or physical examination results that suggest the acute LBP or any of the neurological symptoms or signs are caused by a serious medical condition (e.g., fever, chills, unexplained weight loss, bowel or urinary bladder dysfunction or incontinence, bilateral leg weakness, progressive weakness, paralysis), - There is a high probability for surgical intervention for the back pain during the projected time on the study or that there will be an increase in the severity of the leg pain or deficits, - Had either a surgical procedure involving the spine or intervertebral discs in the lower back region within 1 year prior to Visit 1 or had >1 surgical procedure(s) involving the spine or intervertebral discs in the lower back region, - Has any painful condition that could interfere with the study assessments or with the patient's ability to differentiate the pain associated with the acute LBP episode from pain associated with another condition, - History of epilepsy or recurrent seizures, - Unable or unwilling to discontinue all prohibited medications at the time of randomization and during the time of their participation in the study, - Known or suspected history of alcohol or drug abuse based on medical history, physical examination, urine drug screening, or the Investigator's clinical judgment, - Have filed or plan to file a worker's compensation claim fo
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary endpoint will be assessed by: - Systemic safety and tolerability assessed by Investigaor at DAYs 1 and 5 - Local tolerability assessed subjectively (erythema,itching and burning) using a 4-point scale (where 0=none, 1=mild, 2=moderate, and 3=severe) by patient every day during the treatment period and clinicallyt by Investigator (erythema) on DAYs 1 and 5; Incidence of adverse events, vital signs and laboratory evaluations.;Main Objective: Evaluation of the systemic safety (vital signs, laboratory evaluations and incidence of adverse events) of the study drug assessed by Investigator taking into consideration the change from baseline to DAY 5, the local tolerability assessed by the patient every day during the treatment period and by Investigator.;Secondary Objective: Change in spontaneous pain intensity using the Visual Analogue Scale (VAS) score (100 mm) evaluated at baseline and at DAY 5 (Visit V4).;Timepoint(s) of evaluation of this end point: on DAYs 1 and 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints will be evaluated taking into consideration the change from baseline to DAY 5 in terms of: - The delta of VAS spontaneous pain intensity from baseline to DAY 5(100 mm). The 100 mm VAS score will consider a 0 mm value as NO pain, and 100 mm value as the most SEVERE pain imaginalble. - Hand To Floor Distance (HTFD) evaluated by Investigator on DAY 1 and 5. HTFD will be measured by the Invesigators who will ask the patients to bend forward and try to touch the floor with the fingers; the remaining distance between fingers and ground ("hand to floor") will be measured by means of a rule (cm) (18); - Change in spontaneous pain intensity at rest from baseline AM and PM from day, evaluated using a 100 mm VAS; - Time to 50% pain relief; - Proportion of patients achieving 50% or more pain relief (i.e. responders) on DAY 5; - Time to first rescue medication and total amount of rescue medication; - Proportion of withdrawn patients and time to withdrawal due to treatment failure; - Quality of Life by SF-36 questionnaire.;Timepoint(s) of evaluation of this end point: From baseline to DAY 5 | — |
Countries
Italy
Contacts
Public ContactOPERAZIONI CLINICHE
SINTESI RESEARCH SRL
Outcome results
None listed