Acute low back pain (LBP) MedDRA version: 20.0 Level: LLT Classification code 10024891 Term: Low back pain System Organ Class: 100000004859
Conditions
Interventions
Product Name: Diclofenac/Thiocolchicoside
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Diclofenac Sodium
CAS Number: 15307-79-6
Other descriptive name: DICLOFENAC SODIUM PH. EUR.
Sponsors
WinMedica SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In order to be included, subjects will have to meet all of the following criteria: -age =18 years old -presenting with acute low back pain having started =7 days with moderate to severe intensity (=40 mm on VAS) -able to understand the requirements of the clinical trial and to agree to return for the required follow-up visits; -willing to provide voluntary written informed consent and data protection declaration before any clinical trial related procedure is performed. 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 67 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 67
Exclusion criteria
Exclusion criteria: In order to be included, subjects will have to meet none of the following criteria: -In order to be included, subjects will have to meet none of the following criteria: -back pain due to metastatic cancer spinal infection, or spinal cord compression -patients with a history of presence of peptic ulceration or gastrointestinal bleeding or severe dyspepsia -patients allergic to NSAIDs and skeletal muscle relaxants -patients suffering from asthma or other allergic disorders induced by ASA or NSAIDS -patients treated with NSAIDs or skeletal muscle relaxants for at least 24 h with severe concurrent systemic disease including bleedings diathesis, patients suffering from severe heart disease, severe hepatic or renal impairment -pregnancy or breast-feeding or childbearing potential not protected by a highly effective contraceptive method of birth control - current participation or not yet completed period of at least 30 days since ending other investigational device or drug trial(s); -unwillingness or inability to comply with the clinical trial procedures; -unwillingness to consent to storage, saving and transmission of pseudonymous medical data for clinical trial reasons; -who are legally incapacitated; -who are legally detained in an official institute.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confirm the effectiveness of a new Combination IM product of Thiocolchicoside and Diclofenac (Test product) compared to Diclofenac IM (Voltaren®/Novartis©) (Reference product) in patients with acute low back pain (LBP), on relief of pain as assessed by the patient by means of a 10 cm visual analogue scale (VAS) (scoring range 0–100) at the Test of Cure visit (3 hours from the time of administration of the medicinal product).;Secondary Objective: •To estimate the clinical improvement of muscle spasm of the Test compared to Reference at the Test of Cure visit (3 hours from the time of administrating the medicinal product). •To estimate the relief of pain of the Test product compared to the Reference at the Intermediate visit (1 hour from the time of administrating the medicinal product). •To estimate the clinical improvement of muscle spasm of the Test compared to the Reference at the Intermediate visit (1 hour from the time of administrating the medicinal product). •To demonstrate the safety and tolerability profile of the Test product compared to the Reference by assessing the occurrence of either topical or systemic AEs. ;Primary end point(s): Mean change in VAS from baseline to 3 hours after administration;Timepoint(s) of evaluation of this end point: At screening and 3 hours post administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Mean change in VAS from baseline to 1 hour after administration •Proportion of patients with >30% reduction in pain intensity from baseline at 3 hours •Proportion of patients with >30% reduction in pain intensity from baseline at 1 hour •mean change of Finger-to floor distance from baseline to 3 hours post administration •mean change of Finger-to floor distance from baseline to 1 hour post administration •Proportion of patients withdrawn for reasons related to treatment and the proportion of patients experiencing adverse events ;Timepoint(s) of evaluation of this end point: At screening, 1 hour post administration, 3 hours post administration | — |
Countries
Greece
Contacts
Public ContactCLINICAL TRIAL INFORMATION
BECRO
Outcome results
None listed