Orphenadrine citrate; Paracetamol; Diclofenac potassium for Low back pain

Inclusion criteria

• {"criterion_text":"- age 18-64 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":"- 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":"- Untreated active hepatopathy"}
• {"criterion_text":"- Severe hepatocellular failure"}
• {"criterion_text":"- Hepatic failure"}
• {"criterion_text":"- Renal Failure (GFR <15 mL/min./1.73m2)"}
• {"criterion_text":"- Established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease"}
• {"criterion_text":"- Glaucoma"}
• {"criterion_text":"- Urinary retention (e.g. prostatic hypertrophy or cervical bladder obstruction)"}
• {"criterion_text":"- Severe myasthenia"}
• {"criterion_text":"- Obstructive conditions of the gastrointestinal tract, e.g. pyloric stenosis, duodenum stenosis, stenotic stomach ulcer, megacolon."}
• {"criterion_text":"- Active gastric or intestinal ulcer, bleeding or perforation."}
• {"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":"- Use of prohibited medication (See Section 9.1)"}
• {"criterion_text":"- Treatment with NSAIDs or skeletal muscle relaxants within the past 24 hours"}
• {"criterion_text":"- Participation in another trial within the last 30 days, using IMPs or device"}
• {"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":"- Chronic malnutrition"}
• {"criterion_text":"- Other back-related conditions that may interfere with study assessments (See Section 7.6.3)"}
• {"criterion_text":"- Other conditions that can interfere with study assessments (See Section 7.6.3)"}
• {"criterion_text":"- Neurological or Psychiatric Conditions (See Section 7.6.3)"}
• {"criterion_text":"- Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding)."}
• {"criterion_text":"- History of gastrointestinal bleeding or perforation, relating to previous NSAID therapy."}
• {"criterion_text":"- Pregnancy or breast-feeding or childbearing potential not protected by a highly effective contraceptive method of birth control"}

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":"Cumulative time-weighted sum of daily SPID0-6h values over 7 days (sum of seven daily SPIDs from 0–6 hours post-dose). 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 calculated for each treatment day (days 1–7) and 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 with 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 collected throughout study and 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 FFD test score from baseline to day 7; compared between groups."}

Greece

Earliest CTIS Part Ii Submission Date

25-08-2025

Latest Decision Or Authorization Date

19-03-2026

Processing Time Days

206

Number Of Sites

5

Number Of Participants

224

Primary sponsor

Full Name

Verisfield Single Member S.A.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Greece

Third parties

• {"country":"Greece","full_name":"Agilis S.A. Statistics & Informatics","duties_or_roles":"sponsorDuties codes: 6, 7","organisation_type":"Industry"}
• {"country":"Greece","full_name":"Ioannis Bassiakos","duties_or_roles":"sponsorDuties code: 10","organisation_type":"Educational Institution"}