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.

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]

Trial duration

13 Dec 2024 → 5 Jun 2025

Decision date (initial)

2024-08-28

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: Safety, Efficacy

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).

Secondary objectives 4

1. To estimate the clinical improvement of muscle spasm, as assessed by the investigator of the Test compared to Reference at the Test of Cure visit (3 hours from the time of administrating the investigational medicinal product).
2. To estimate the relief of pain with the use of the Test product compared to the Reference at the Intermediate visit (VAS score, 1 hour from the time of administrating the medicinal product).
3. To estimate the clinical improvement of muscle spasm, as assessed by the investigator, of the Test compared to the Reference at the Visit 2 (1 hour from the time of administrating the investigational medicinal product).
4. To investigate the safety and tolerability profile of the Test product compared to the Reference by assessing the occurrence of either topical or systemic AEs.

Conditions and MedDRA coding

Acute moderate to severe 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 moderate to severe intensity (≥50 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 11

1. back pain due to metastatic cancer spinal infection, or spinal cord compression
2. history of presence of peptic ulceration or gastrointestinal bleeding or severe dyspepsia
3. allergy to NSAIDs and skeletal muscle relaxants
4. asthma or other allergic disorders induced by ASA or NSAIDS
5. 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
6. pregnancy or breast-feeding or childbearing potential not protected by a highly effective contraceptive method of birthcontrol
7. participation in another trial within the last 30 days, using IMPs or device
8. unwillingness or inability to comply with the clinical trial procedures
9. unwillingness to consent to storage, saving and transmission of pseudonymous medical data for clinical trial reasons
10. legal incapacitation
11. who are legally detained in an official institute

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Mean change in VAS from baseline to 3 hours after administration

Secondary endpoints 6

1. Mean change in VAS from baseline to 1 hour after administration
2. Proportion of patients with >30% reduction in pain intensity from baseline at 3 hours
3. Proportion of patients with >30% reduction in pain intensity from baseline at 1 hour
4. Mean change of Finger-to floor distance from baseline to 3 hours post administration
5. Mean change of Finger-to floor distance from baseline to 1 hour post administration
6. Proportion of patients withdrawn for reasons related to treatment and the proportion of patients experiencing adverse events

Investigational products

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

Test 1

Comparator 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

1 EU/EEA country · 4 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

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

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 2 files

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

Application history

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