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Study to compare the effectiveness and tolerability of the injectable combination of Diclofenac and Thiocolchicoside against injectable Diclofenac alone in patients with low back pain.
EU CTIS ID: 2024-512786-13-00
What this study is testing
To confirm the superior efficacy of a Combination IM product of Thiocolchicoside and Diclofenac (Test product) compared to Diclofenac IM (Voltaren®/Novartis) (Reference product) in patients with acute moderate to severe 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 IMP).
- 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 moderate to severe intensity (≥50 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
- back pain due to metastatic cancer spinal infection, or spinal cord compression
- legal incapacitation
- who are legally detained in an official institute
- history of presence of peptic ulceration or gastrointestinal bleeding or severe dyspepsia
- allergy to NSAIDs and skeletal muscle relaxants
- asthma or other allergic disorders induced by ASA or NSAIDS
See the full eligibility criteria
- age ≥18 years old
- presenting with acute low back pain having started ≤7 days with moderate to severe intensity (≥50 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)
- back pain due to metastatic cancer spinal infection, or spinal cord compression
- legal incapacitation
- who are legally detained in an official institute
- history of presence of peptic ulceration or gastrointestinal bleeding or severe dyspepsia
- allergy to NSAIDs and skeletal muscle relaxants
- asthma or other allergic disorders induced by ASA or NSAIDS
- treatment 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 birthcontrol
- participation in another trial within the last 30 days, using IMPs or device
- 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
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.