BridgeMD
A Study Comparing the Efficacy and Tolerability of a Combination of Diclofenac and Thiocolchicoside Versus Diclofenac Monotherapy in Patients with Low Back Pain.
EU CTIS ID: 2025-523153-33-00
What this study is testing
To evaluate the therapeutic superiority of the Fixed-Dose Combination (FDC) Test Product compared to active comparator (Cataflam®) and placebo in patients with acute severe low back pain (LBP), as measured by the Total Sum of Pain Intensity Differences (SPID) over 7 days.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- age ≥18 years old
- presenting with acute low back pain having started ≤7 days with severe intensity (≥75 mm on VAS)
- 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)
- willing to provide voluntary written informed consent before any clinical trial related procedure is performed (also refers to legally authorized representatives, where applicable)
You likely can't join if
- Hypersensitivity to any of the active substances or excipients
- 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.
- Participation in another trial within the last 30 days, using IMPs or device
- Active gastric or intestinal ulcer, bleeding or perforation
- 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
See the full eligibility criteria
- age ≥18 years old
- presenting with acute low back pain having started ≤7 days with severe intensity (≥75 mm on VAS)
- 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)
- willing to provide voluntary written informed consent before any clinical trial related procedure is performed (also refers to legally authorized representatives, where applicable)
- Hypersensitivity to any of the active substances or excipients
- 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.
- Participation in another trial within the last 30 days, using IMPs or device
- Active gastric or intestinal ulcer, bleeding or perforation
- 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
- Legal incapacitation
- Legal detention in an official institute
- Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding)
- Hepatic failure
- Renal Failure (GFR <15 mL/min./1.73m2)
- Flaccid paralysis or muscle hypotonia
- 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
- History of gastrointestinal bleeding or perforation, relating to previous NSAID therapy
- 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)
- Established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease
- Patients with defects of haemostasis, bleeding diathesis or haematological abnormalities.
- Patients with hepatic porphyria.
- Frail elderly patients
- Patients with low body weight (< 50kg)
- 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.
- Severe hepatocellular insufficiency/failure or decompensated active liver disease
- 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
- Other back-related conditions that may interfere with study assessments (See Section 7.6.4)
- Other conditions that can interfere with study assessments (See Section 7.6.4)
- Neurological or Psychiatric Conditions (See Section 7.6.4)
- Use of prohibited medication (See Section 9.1)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.