A Study Comparing the Efficacy and Tolerability of a Combination of Diclofenac and Thiocolchicoside Versus Diclofenac Monotherapy in Patients with Low Back Pain.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Verisfield Single Member S.A.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

Decision date (initial)

2026-04-16

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

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.

Secondary objectives 5

1. To compare the average daily analgesic effect over 7 days across treatment groups.
2. To compare the cumulative use of rescue medication from baseline to day 7 across treatment groups.
3. To compare the proportion of patients achieving clinically meaningful pain relief (responders) by day 7 between groups.
4. To compare the safety and tolerability profiles of the IMPs throughout the study period.
5. To compare functional improvement from baseline to day 7 between groups.

Conditions and MedDRA coding

LOW BACK PAIN

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. age ≥18 years old
2. presenting with acute low back pain having started ≤7 days with severe intensity (≥75 mm on VAS)
3. 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)
4. 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 27

1. Hypersensitivity to any of the active substances or excipients
2. Flaccid paralysis or muscle hypotonia
3. 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.
4. Severe hepatocellular insufficiency/failure or decompensated active liver disease
5. 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
6. Other back-related conditions that may interfere with study assessments (See Section 7.6.4)
7. Other conditions that can interfere with study assessments (See Section 7.6.4)
8. Neurological or Psychiatric Conditions (See Section 7.6.4)
9. Use of prohibited medication (See Section 9.1)
10. 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.
11. Participation in another trial within the last 30 days, using IMPs or device
12. Active gastric or intestinal ulcer, bleeding or perforation
13. Unwillingness or inability to comply with the clinical trial procedures
14. Unwillingness to consent to storage, saving and transmission of pseudonymous medical data for clinical trial reasons
15. Legal incapacitation
16. Legal detention in an official institute
17. Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding)
18. Hepatic failure
19. Renal Failure (GFR <15 mL/min./1.73m2)
20. 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
21. History of gastrointestinal bleeding or perforation, relating to previous NSAID therapy
22. 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)
23. Established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease
24. Patients with defects of haemostasis, bleeding diathesis or haematological abnormalities.
25. Patients with hepatic porphyria.
26. Frail elderly patients
27. Patients with low body weight (< 50kg)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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.

Secondary endpoints 5

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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Placebo 2

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Verisfield Single Member S.A.

Sponsor organisation

Verisfield Single Member S.A.

Address

Githiou, Vironos 8 Vironos 8

City

Chalandri

Postcode

152 31

Country

Greece

Scientific contact point

Organisation

Verisfield Single Member S.A.

Contact name

Clinical Department

Public contact point

Organisation

Verisfield Single Member S.A.

Contact name

Clinical Department

Third parties 2

Locations

2 EU/EEA countries · 5 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 10 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications