A placebo- and active-controlled clinical trial to evaluate effectiveness of Tricortin 1000 in patients with chronic low back pai

Phase 1

• Conditions: ow Back Pain; MedDRA version: 21.0Level: LLTClassification code 10052430Term: Chronic lumbagoSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2018-002003-33-IT
• Lead Sponsor: FIDIA FARMACEUTICI S.P.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-29
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Clinical diagnosis of mechanical (mild, moderate degenerative process of disc and facet) LBP, for at least 3 months but no more than 6 months, confirmed (thanks to instrumental analysis obtained within 6 months before the Screening visit) by CT or MRI
2. A moderate to severe Chronic LBP, defined as a score greater or = 4 and less or = 8 rated on the NRS-11
3. Age greater than or equal to 40 and less than or equal to 70 years
4. Patient able to maintain a Diary during the study
5. Patient with a Body Mass Index (BMI) < 30 kg/m2
6. 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
7. Patients who did not receive antidepressant medications and/or benzodiazepines for at least 60 days
8. 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
9. Patient has undergone the informed consent process and has signed an approved consent form
10. 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
11. Patients who did not use Tricortin 1000 in the past to treat LBP or other pathological conditions.
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 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

1. Patients suffering of chronic non-specific LBP
2. Females who are pregnant or breast-feeding
3. Patients who are not able to give informed consent
4. Patients who cannot commit to the entire duration of the study
5. 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
6. Patients who have a primary bone disease, cancer, infection
7. 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
8. History of narcotic abuse at any time in the past and/or drug or alcohol abuse in the past year
9. 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
10. Participation in another research study
11. History of epilepsy
12. Patients who have an unstable psychiatric condition

Study & Design

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