This Phase III study will compare the efficacy and tolerability of a combination IM product of Thiocolchicoside and Diclofenac vs. Diclofenac (Voltaren®) IM in patients with acute low back pain

Phase 1

• Conditions: Acute low back pain (LBP); MedDRA version: 20.0Level: LLTClassification code 10024891Term: Low back painSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2017-004530-29-GR
• Lead Sponsor: WinMedica SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-12-04
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 134

Inclusion Criteria

In order to be included, subjects will have to meet all of the following criteria:
-age =18 years old
-presenting with acute low back pain having started =7 days with moderate to severe intensity (=40 mm on VAS)
-able to understand the requirements of the clinical trial and to agree to return for the required follow-up visits;
-willing to provide voluntary written informed consent and data protection declaration before any clinical trial related procedure is performed.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 67
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 67

Exclusion Criteria

In order to be included, subjects will have to meet none of the following criteria:
-In order to be included, subjects will have to meet none of the following criteria:
-back pain due to metastatic cancer spinal infection, or spinal cord compression
-patients with a history of presence of peptic ulceration or gastrointestinal bleeding or severe dyspepsia
-patients allergic to NSAIDs and skeletal muscle relaxants
-patients suffering from asthma or other allergic disorders induced by ASA or NSAIDS
-patients treated 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 birth control
-current participation or not yet completed period of at least 30 days since ending other investigational device or drug trial(s);
-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;
-who are legally incapacitated;
-who are legally detained in an official institute.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified