Randomized, double-blind, parallel-groups, active-controlled trial to evaluate the efficacy of a fixed combination of diclofenac 75 mg + thiocolchicoside 4 mg as solution for injection, in improving back pain symptoms

Phase 1

• Conditions: low back pain; MedDRA version: 18.0Level: LLTClassification code 10024891Term: Low back painSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2015-002476-24-IT
• Lead Sponsor: Epifarma S.r.l.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-08
• Last Update Posted: 31 January 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•Male and female patients aged 18-65 years;
•Patients with acute LBP, defined as pain initiating from the area below the tips of the scapulae and above the buttocks, with onset no more than 7 days prior to the screening visit;
•Back pain of moderate to severe intensity, defined as = 50 mm at VAS;
•If female and of child-bearing potential, the patient must be non-nursing and should not become pregnant throughout the whole study duration; all females of child-bearing potential must have a negative urine pregnancy test prior the first administration;
•Satisfactory general health status as determined by the investigator based on medical history and physical examination;
•Patients must understand and provide written informed consent before they can participate in the study. They must understand the study procedures of the trial, and be willing to complete the required assessments.

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 240
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 240

Exclusion Criteria

•Patients unwilling to give an informed consent approval;
•Patients with a history of cervical, thoracic, or lumbosacral pain for = 50% of the time in the year prior to screening;
•Patients with presence of lumbosciatalgia;
•Patients with a history of any LBP episode, except the current acute episode, within 3 months prior to screening that was associated with disability, or required treatment with an opioid analgesic;
•Patients with acute LBP caused by a serious or malignant condition;
•Patients with acute LBP of traumatic origin;
•Patients on treatment with anticoagulant agents;
•Patients who underwent spinal surgery in the year prior to screening or had a history of more than one spinal surgery;
•Patients who had a history of severe lumbar spinal stenosis, fibromyalgia, or ankylosing spondylitis;
•Patients with a medical history of seizures;
•Pregnancy or lactation period;
•Women with childbearing potential who are not using adequate methods to avoid pregnancy;
•Women with polymenorrhea;
•History of alcohol or drug abuse;
•History of allergy or hypersensitivity or intolerance to diclofenac or thiocolchicoside, and/or to active or inactive excipients of the used investigational study products (IMPs) formulations;
•Known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs), and in particular to paracetamol;
•Use of non-steroid anti-inflammatory drugs (e.g. acetyl salicylic acid) and analgesics (with the exception of paracetamol) in the week before the study. Chronic intake of small doses of acetylsalicylic acid (= 162 mg/daily) taken for at least 30 days prior to the first dose of study medication for non-analgesic reasons may be continued for the duration of the study;
•Use of any other treatment or medication that can alter the perception of pain (e.g. heparinoids, opioids, psychotropic agents, anti H1 agents or analgesics like glucocorticosteroids, NSAIDs, etc.) for the same indication or other indications (e.g. rheumatoid arthritis); in the week before the study.
•History of active or suspected esophageal, gastric, pyloric channel, or duodenal ulceration or bleeding within 30 days preceding screening;
•History of uncontrolled chronic or acute concomitant disease which, in the Investigator’s opinion, would contraindicate study participation or confound interpretation of the results;
•Participation in any other clinical study within 30 days prior to the screening.

Study & Design

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