NCT04585334

Effectiveness of Tricortin 1000 in Patients Affected by Chronic Low Back Pain

A Double Blind, Double Dummy, Multicenter, Randomized, Placebo- and Active-controlled Clinical Trial to Evaluate Effectiveness of Tricortin 1000 in Patients Affected by Chronic Low Back Pain

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Fidia Farmaceutici s.p.a. · Industry
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

PAES, double blind, double dummy, multicenter, randomized, controlled clinical study to demonstrate superiority of Tricortin 1000 over placebo in improvement in pain relief as change from baseline to 15 days in patients with chronic low back pain (LBP).

Detailed description

This is a PAES, double blind, double dummy, multicenter, randomized, controlled clinical study, which will consist of a Screening phase (Visit 1) of up to 14 days and a Follow-up phase of up to 15 days. A total of 300 patients of either sex, aged between 40 and 70 years with diagnosis of chronic mechanical (mild, moderate degenerative process of disc and facet) LBP for at least 3 months but no more than 6 months will be randomized. Two stratification groups will be distinguished: the first group will be comprised of patients with chronic mechanical LBP due to mild, moderate degenerative process of disc and facet from 40 to \<55 years, the second group will be comprised of patients with chronic mechanical LBP due to mild-moderate degenerative process of disc and facet ≥55 to 70 years. All patients will be required to have diagnosis of chronic LBP with clinically and imaging confirmation of mechanical (mild, moderate degenerative process of disc and facet). Baseline assessments include: pain assessment and functional disability, clinical parameters, patient global assessment (PGA), clinical global impression (CGI) and consumption of rescue medication. Eligible patients will then be randomly assigned to one of the following three treatment arms: 1. Tricortin 1000 by intramuscular route (Arm A) 2. Diclofenac sodium medicated plaster by topical application (Arm B) 3. Placebo (Arm C) In arm A and B, Tricortin 1000 and Diclofenac sodium medicated plaster will be administered together with the alternate placebo, while patients in the placebo arm (Arm C) will be treated with both intramuscular and locally applied placebo. Patients will be in the study for approximately 30 days of trial duration with a treatment period of 15 days.

Conditions

• Low Back Pain, Mechanical

Interventions

Type	Name	Description
DRUG	Tricortin 1000	Tricortin 1000 \[2 mL ampoules containing 12 mg of phospholipids and 1 mg of Vitamin B12 (Cyanocobalamin)\] will be administered intramuscular on the gluteus, once daily (24 hours apart), for 15 days starting from the evening of Day 0 (visit 2) plus Diclofenac sodium medicated plaster placebo will be applied twice daily (12 hours apart) for 15 days starting from the evening of Day 0 (visit 2), i.e. 30 applications.
DRUG	Itami	Diclofenac sodium 140 mg medicated plaster (Itami®) will be applied twice daily (12 hours apart) for 15 days starting from the evening of Day 0 (visit 2), i.e. 30 applications plus Tricortin 1000 placebo (2 mL ampoules) will be administered intramuscular on the gluteus, once daily (24 hours apart), for 15 days starting from the evening of Day 0 (visit 2).
DRUG	Placebo	Tricortin 1000 placebo (2 mL ampoules) will be administered intramuscular on the gluteus, once daily (24 hours apart), for 15 days starting from the evening of Day 0 (visit 2) plus Diclofenac sodium medicated plaster placebo will be applied twice daily (12 hours apart) for 15 days starting from the evening of Day 0 (visit 2), i.e. 30 applications.

Timeline

• Start date: 2019-03-25
• Primary completion: 2024-12-01
• Completion: 2025-01-01
• First posted: 2020-10-14
• Last updated: 2023-10-27

Locations

13 sites across 1 country: Italy