Thiocolchicoside; Diclofenac potassium for Low back pain

Inclusion criteria

• {"criterion_text":"- age ≥18 years old"}
• {"criterion_text":"- presenting with acute low back pain having started ≤7 days with severe intensity (≥75 mm on VAS)"}
• {"criterion_text":"- able to understand the requirements of the clinical trial and to agree to return for the required follow-up visits (also refers to legally authorized representatives, where applicable)"}
• {"criterion_text":"- willing to provide voluntary written informed consent before any clinical trial related procedure is performed (also refers to legally authorized representatives, where applicable)"}

Exclusion criteria

• {"criterion_text":"- Hypersensitivity to any of the active substances or excipients"}
• {"criterion_text":"- Treatment with NSAIDs or skeletal muscle relaxants within a period equivalent to at least 5 times the elimination half-life of the respective active substance prior to the administration of the first dose of the Investigational Medicinal Product."}
• {"criterion_text":"- Participation in another trial within the last 30 days, using IMPs or device"}
• {"criterion_text":"- Active gastric or intestinal ulcer, bleeding or perforation"}
• {"criterion_text":"- Unwillingness or inability to comply with the clinical trial procedures"}
• {"criterion_text":"- Unwillingness to consent to storage, saving and transmission of pseudonymous medical data for clinical trial reasons"}
• {"criterion_text":"- Legal incapacitation"}
• {"criterion_text":"- Legal detention in an official institute"}
• {"criterion_text":"- Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding)"}
• {"criterion_text":"- Hepatic failure"}
• {"criterion_text":"- Renal Failure (GFR <15 mL/min./1.73m2)"}
• {"criterion_text":"- Flaccid paralysis or muscle hypotonia"}
• {"criterion_text":"- Pregnancy or breast-feeding or women with childbearing potential not protected by a highly effective contraceptive method of birth control during treatment and for one month after stopping treatment"}
• {"criterion_text":"- History of gastrointestinal bleeding or perforation, relating to previous NSAID therapy"}
• {"criterion_text":"- Patients in whom the use of acetylsalicylic acid or other NSAIDs can precipitate asthma, angioedema, urticaria or acute rhinitis (i.e. NSAID-induced cross-reactivity reactions)"}
• {"criterion_text":"- Established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease"}
• {"criterion_text":"- Patients with defects of haemostasis, bleeding diathesis or haematological abnormalities."}
• {"criterion_text":"- Patients with hepatic porphyria."}
• {"criterion_text":"- Frail elderly patients"}
• {"criterion_text":"- Patients with low body weight (< 50kg)"}
• {"criterion_text":"- Men who are not willing to use a condom, or whose female partners of childbearing potential are not using a highly effective contraceptive method (failure rate less than 1 percent per year), for the duration of treatment and for 3 months after the final dose."}
• {"criterion_text":"- Severe hepatocellular insufficiency/failure or decompensated active liver disease"}
• {"criterion_text":"- Participants who are performing some type of oral, physical or topical treatment for low back pain (e.g., acupuncture, local heat and yoga) and / or initiation of physiotherapy program in the last 2 months before the start of the study"}
• {"criterion_text":"- Other back-related conditions that may interfere with study assessments (See Section 7.6.4)"}
• {"criterion_text":"- Other conditions that can interfere with study assessments (See Section 7.6.4)"}
• {"criterion_text":"- Neurological or Psychiatric Conditions (See Section 7.6.4)"}
• {"criterion_text":"- Use of prohibited medication (See Section 9.1)"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint is the cumulative, time-weighted sum of pain intensity differences (SPID), expressed as the sum of seven daily SPIDs from 0 to 6 hours post-dose (SPID0-6h) across the 7-day treatment period, compared between groups.","definition_or_measurement_approach":"Sum of seven daily SPIDs from 0 to 6 hours post-dose (SPID0-6h) across the 7-day treatment period; cumulative, time-weighted sum compared between groups."}

Secondary endpoints

• {"endpoint_text":"- Average analgesic effect: The daily SPID0-6h for each one of the 7 treatment days, compared between groups.","definition_or_measurement_approach":"Daily SPID0-6h for each treatment day, compared between groups."}
• {"endpoint_text":"- Rescue medication use: Mean number of rescue medication tablets consumed per participant from baseline to day 7 compared between groups.","definition_or_measurement_approach":"Mean number of rescue medication tablets consumed per participant from baseline to day 7; compared between groups."}
• {"endpoint_text":"- Responder rate: Proportion of patients achieving mild pain (e.g., VAS <45 mm) by day 7 compared between groups.","definition_or_measurement_approach":"Proportion of patients achieving predefined pain threshold (e.g., VAS <45 mm) by day 7; compared between groups."}
• {"endpoint_text":"- Safety and tolerability: Incidence and proportion of participants experiencing adverse events throughout the study period compared between groups.","definition_or_measurement_approach":"Incidence and proportion of participants with adverse events recorded throughout the study period; compared between groups."}
• {"endpoint_text":"- Functional improvement: Mean percent change in Finger-to-Floor Distance (FFD) test score from baseline to day 7 compared between groups.","definition_or_measurement_approach":"Mean percent change in Finger-to-Floor Distance (FFD) test score from baseline to day 7; compared between groups."}

Cyprus

Earliest CTIS Part Ii Submission Date

26-03-2026

Latest Decision Or Authorization Date

16-04-2026

Processing Time Days

21

Number Of Sites

1

Number Of Participants

20

Greece

Earliest CTIS Part Ii Submission Date

16-12-2025

Latest Decision Or Authorization Date

16-04-2026

Processing Time Days

121

Number Of Sites

4

Number Of Participants

90

Primary sponsor

Full Name

Verisfield Single Member S.A.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Greece

Third parties

• {"country":"Greece","full_name":"Ioannis Bassiakos","duties_or_roles":"sponsorDuties code: 10; contact email: ybassiak@econ.uoa.gr","organisation_type":"Educational Institution"}
• {"country":"Greece","full_name":"Agilis S.A. Statistics & Informatics","duties_or_roles":"sponsorDuties code: 7; contact email: contact@agilis-sa.gr","organisation_type":"Industry"}