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

NCT04585334 | Unknown Phase 4

• 1 other identifier: EQ06.17.01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 13

Brief 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).

Conditions

Low Back Pain, Mechanical

Keywords

Chronic; Degenerative process of disc and facet

Outcome Measures

Primary Outcomes (1)

• Change from baseline to 15 days in patients with chronic low back pain (LBP) and acute exacerbation at study entry using Numerical Rating Scale for pain

  The primary efficacy endpoint will be the change from baseline to Day 15 in NRS-11 score.(0-10 points Numerical Rating Scale for pain, where score 0 corresponds to no pain and score 10 corresponds to unimaginable pain)

  Day 15

Secondary Outcomes (9)

• Improvement in pain relief as change from baseline to 15 days in patients with chronic LBP and acute exacerbation at study entry, using Numerical Rating Scale for pain

  Day 15

• Functional disability improvement as change from baseline to 15 days through the Oswestry Low Back Pain Disability Index (ODI), version 2.1a

  Day 0, Day 7 and Day 15

• Clinical improvement as change from baseline to 15 days

  Day 0, Day7 and Day 15

• Patient global assessment PGA as change from baseline to 15 days. PGA:single-item measure:Considering all the ways that your LBP affect you,select one response for how you are doing at the moment:0=very well;1=well;2=fair;3=poor;4=very poor

  Day 0, Day7 and Day 15

• ClinicalGlobalImpression as change from baseline to15days.CGI:7point scale clinician-rated(severity of illness)from1(normal)to7(severely ill).CGI score from1(very much improved)to7(very much worse).Treatment response consider efficacy and AEs

  Day 0, Day7 and Day 15

Study Arms (3)

Arm A Tricortin

EXPERIMENTAL

Tricortin 1000 by intramuscular route

Drug: Tricortin 1000

Arm B Itami

ACTIVE COMPARATOR

Itami Diclofenac sodium medicated plaster by topical application

Drug: Itami

Arm C Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Tricortin 1000 DRUG

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.

Also known as: Tricortin

Arm A Tricortin

Itami DRUG

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).

Also known as: Diclofenac sodium 140 mg medicated plaster

Arm B Itami

Placebo DRUG

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.

Also known as: Placebo plaster and Tricortin placebo

Arm C Placebo

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of mechanical (mild, moderate degenerative process of disc and facet) chronic LBP, for at least 3 months but no more than 6 months, confirmed (thanks to instrumental analysis obtained within 9 months before the Screening visit) by CT or MRI. In case a MRI/CT performed in the previous 9 months is not available, the diagnosis should be confirmed by means of a MRI performed between Screening visit (Visit 1) and Baseline visit (Visit 2)
• A moderate to severe acute exacerbation of Chronic LBP at study entry, defined as a score ≥4 and ≤8 rated on the NRS-11
• Age greater than or equal to 40 and less than or equal to 70 years
• Patient able to maintain a Diary during the study
• Patient with a Body Mass Index (BMI) \< 30 kg/m2
• Discontinuation of any analgesic/NSAID therapy, opioids, corticosteroids, skeletal muscle relaxants and any other medication or non-pharmacological therapy (if it would interfere with the study assessments), with no intent to resume during study
• Patients who did not receive antidepressant medications and/or benzodiazepines for at least 60 days
• Patient able to read and understand the language and content of the study material, understand the requirements for follow-up visits, is willing to provide information at the scheduled evaluations and is willing and able to comply with the study requirements
• Patient has undergone the informed consent process and has signed an approved consent form
• If female, patient must have a negative urine pregnancy test and use a highly effective form of contraception for at least one month prior to screening and throughout the study; or females must be surgically sterile, or postmenopausal as documented in medical history for at least one year. Highly effective birth control methods include: combined hormonal contraception (containing estrogen and progestogen) associated with inhibition of ovulation (oral, intravaginal, transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomised partner; sexual abstinence\*
• Patients who did not use Tricortin 1000 in the past to treat LBP or other pathological conditions.
• Note: According to 4.1 paragraph "Birth control methods which may be considered as highly effective" of the CTFG/Recommendations related to contraception and pregnancy testing in clinical trials
• In aptients for which a MRI/CT performed in the previous 9 months is not available, the diagnosis of chronic LBP should be confirmed by means of a MRI performed between screening visit (Visit 1) and baseline (Visit 2)
• LBP with score ≥ 5 and ≤ 8 in the NRS-11 (off medication except for paracetamol, study rescue medication)
• Patient has discontinued use of all analgesic/NSAIDs, opioids, corticosteroids, skeletal muscle relaxants, and any other medication or non-pharmacological therapy (if it would interfere with the study assessments) at V1 (except for patients that will perform the MRI between Screening and Baseline visit) and agree not to resume them during study (except for paracetamol, study rescue medication). These medication must be discontinued for at least 14 days before the Baseline visit (Visit 2/ Day 0), i.e. can be taken for maximum 7 days during the 14-21 days of Screening phase, in case that the screening phase is prolonged up to 21 days in patients that will perform the MRI between screening and baseline visit.

You may not qualify if:

• Related to patients
• Patients suffering of chronic non-specific LBP
• Females who are pregnant or breast-feeding
• Patients who are not able to give informed consent
• Patients who cannot commit to the entire duration of the study
• Patients with back pain referred from a mechanical cause (except for mild, moderate degenerative process of disc and facet) non spinal source or back pain associated with another specific spinal cause
• Patients who have a primary bone disease, cancer, infection (except for osteoporosis patients without fracture history)
• Other conditions which may confound the interpretation of the study, such as carpal, rheumatoid arthritis, severe venous diseases, peripheral arterial diseases, transient ischemic attack, stroke, current symptoms of coronary artery disease
• History of narcotic abuse at any time in the past and/or drug or alcohol abuse in the past year
• Patients who have had a previous treatment with physical therapy for LBP in the last 4 weeks before the screening visit or are going through a course of physical therapy or chiropractic treatment at the time of planned enrolment
• Participation in another research study
• History of epilepsy
• Patients who have an unstable psychiatric condition
• Red flags as possible indicators of serious spinal pathology:
• Unexplained serious thoracic pain

Sponsors & Collaborators

• Fidia Farmaceutici s.p.a.: lead

Study Sites (13)

ATS Insubria

Porlezza, Como, 22018, Italy

RECRUITING

ATS Insubria

Alzate Brianza, 22040, Italy

RECRUITING

UOC Medicina Fisica e Riabilitazione - Unità Spinale Unipolare, Azienda OU "Consorziale Policlinico" Bari

Bari, 70125, Italy

RECRUITING

Servizio di Medicina Fisica e Riabilitativa, AOU Policlinico-P.O.G. Rodolico

Catania, 95123, Italy

RECRUITING

U.O. Medicina Fisica e Riabilitativa Azienda ospedaliera Mater Domini

Catanzaro, 88100, Italy

RECRUITING

ATS Insubria

Como, 22100, Italy

RECRUITING

ATS Insubria

Erba, 22036, Italy

RECRUITING

SODC-Riabilitazione Azienda ospedaliero-Universitaria Careggi- Ospedale Careggi

Florence, 50139, Italy

RECRUITING

U.O.C. di Riabilitazione Ortopedica, Azienda Ospedaliera Universitaria di Padova

Padua, 35128, Italy

RECRUITING

U.O.C. di Riabilitazione AOU Policlinico P. Giaccone

Palermo, 90127, Italy

RECRUITING

U.O.C. Medicina Fisica Riabilitativa Azienda Policlinoc Umberto I, Università di Roma La Sapienza

Roma, 00185, Italy

RECRUITING

UOS Medicina Fisica e Riabilitativa Azienda Ospedaliero Universitaria Sant'Andrea-Roma

Roma, 00189, Italy

RECRUITING

U.O.C. Neuroriabilitazione, Dipartimento di Neuroscienze, Azienda Ospedaliera Universitaria Integrata di Verona, Policlinico Borgo Roma

Verona, 37134, Italy

RECRUITING

MeSH Terms

Conditions

Low Back Pain; Bronchiolitis Obliterans Syndrome

Interventions

Diclofenac

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Nicola Giordan

  Fidia Farmaceutici s.p.a.

  STUDY DIRECTOR

Central Study Contacts

Flavia Baruzzi

CONTACT

0039 031734908; flavia.baruzzi@lbresearch.it

Emanuela Terragni

CONTACT

0039 031733133; emanuela.terragni@lbresearch.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind, double dummy
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: PAES, double blind, double dummy, multicenter, randomized, controlled clinical study

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: October 14, 2020
• Study Start: March 25, 2019
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: October 27, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (13)