Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04585334
Recruitment Status : Recruiting
First Posted : October 14, 2020
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
Fidia Farmaceutici s.p.a.

Tracking Information
First Submitted Date  ICMJE March 2, 2020
First Posted Date  ICMJE October 14, 2020
Last Update Posted Date October 14, 2020
Actual Study Start Date  ICMJE March 25, 2019
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 7, 2020)
Change from baseline to 15 days in patients with chronic low back pain (LBP): 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) [ Time Frame: Day 15 ]
The primary efficacy endpoint will be the change from baseline to Day 15 in NRS-11 score.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2020)
  • Improvement in pain relief as change from baseline to 15 days in patients with LBP (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) [ Time Frame: Day 15 ]
    To compare Tricortin 1000 and diclofenac sodium medicated plaster (Itami®) in improvement in pain relief as change from baseline to 15 days in patients with LBP.
  • Functional disability improvement as change from baseline to 15 days through the Oswestry Low Back Pain Disability Index (ODI), version 2.1a [ Time Frame: Day 0, Day 7 and Day 15 ]
    To compare Tricortin 1000 with placebo and diclofenac sodium medicated plaster (Itami®) in functional disability improvement. LBP related disability improvement will be measured through the Oswestry Low Back Pain Disability Index (ODI), version 2.1a, at baseline visit and then in the following visits: V3-Day 7 and V4-Day 15.
  • Clinical improvement as change from baseline to 15 days [ Time Frame: Day 0, Day7 and Day 15 ]
    To compare Tricortin 1000 with placebo and diclofenac sodium medicated plaster (Itami®) in clinical improvement as change from baseline to 15 days. Clinical improvement will be evaluated at baseline visit and then at V3-Day 7 and V4-Day 15 through the following parameters: Range of Motion testing, Joint reflex changes (ROT), Lasegue's test (passive straight leg raise), Femoral stretch test (Wasserman test), Dandy's sign, Valleix's points pressure.
  • 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 [ Time Frame: Day 0, Day7 and Day 15 ]
    To compare Tricortin 1000 with placebo and diclofenac sodium medicated plaster (Itami®) in patient global assessment (PGA) as change from baseline to 15 days. PGA will be evaluated at baseline visit and then in the following visits: V3-Day 7 and V4-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 [ Time Frame: Day 0, Day7 and Day 15 ]
    To compare Tricortin 1000 with placebo and diclofenac sodium medicated plaster (Itami®) in clinical global impression CGI as change from baseline to 15 days. CGI will be evaluated at baseline visit and then in the following visits: V3-Day 7 and V4-Day 15
  • Consumption of rescue medication as change from baseline to 15 days using a patient diary (maximum 4 tablets for 4 days/week) [ Time Frame: From Day -14 to Day 15 ]
    To compare Tricortin 1000 with placebo and diclofenac sodium medicated plaster (Itami®) in consumption of rescue medication as change from baseline to 15 days. Daily rescue medication required for pain relief up to V4-Day 15 using a patient diary
  • Safety as change from baseline to 15 days evaluated by physical examination (body areas:Head;Ears;Eyes;Nose;Mouth;Skin;Heart;Lung;Lymph nodes;Genitourinary;Gastrointestinal;Skeletal;Neurological systems;Other, specify) [ Time Frame: From Day -14 to Day 15 ]
    To compare Tricortin 1000 with placebo and diclofenac sodium medicated plaster in patient safety as change from baseline to 15 days.
  • Safety as change from baseline to 15 days evaluated by vital signs (systolic blood pressure, diastolic blood pressure, heart rate) [ Time Frame: From Day -14 to Day 15 ]
    To compare Tricortin 1000 with placebo and diclofenac sodium medicated plaster in patient safety as change from baseline to 15 days.
  • Safety as change from baseline to 15 days evaluated by tracking the number of patient withdrawals and their adverse events [ Time Frame: From Day -14 to Day 15 ]
    To compare Tricortin 1000 with placebo and diclofenac sodium medicated plaster in patient safety as change from baseline to 15 days.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Tricortin 1000 in Patients Affected by Chronic Low Back Pain
Official Title  ICMJE 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
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).
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
PAES, double blind, double dummy, multicenter, randomized, controlled clinical study
Masking: Double (Participant, Investigator)
Masking Description:
Double blind, double dummy
Primary Purpose: Treatment
Condition  ICMJE Low Back Pain, Mechanical
Intervention  ICMJE
  • 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.
    Other Name: Tricortin
  • 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).
    Other Name: Diclofenac sodium 140 mg medicated plaster
  • 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.
    Other Name: Placebo plaster and Tricortin placebo
Study Arms  ICMJE
  • Experimental: Arm A Tricortin
    Tricortin 1000 by intramuscular route
    Intervention: Drug: Tricortin 1000
  • Active Comparator: Arm B Itami
    Itami Diclofenac sodium medicated plaster by topical application
    Intervention: Drug: Itami
  • Placebo Comparator: Arm C Placebo
    Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 7, 2020)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 ≥4 and ≤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.

    • 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

Baseline Inclusion Criteria:

  1. LBP with score > 5 and ≤ 8 in the NRS-11 (off medication except for paracetamol, study rescue medication)
  2. 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 and agree not to resume them during study (except for paracetamol, study rescue medication).
  3. Patient has complied with the requirements for rescue medication (no more than 4 tablets - 2 grams - of paracetamol per day up to 4 days per week) and no paracetamol intake in the 24 hours before baseline visit
  4. Patient continues to meet all Screening inclusion/exclusion criteria at the Baseline visit, with the exception of screening inclusion criterion 2 which is replaced by baseline inclusion criterion 1

Exclusion Criteria:

Related to patients

  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

    Red flags as possible indicators of serious spinal pathology:

  13. Unexplained serious thoracic pain
  14. Any recent trauma, which may raise the possibility of a fracture
  15. Fever and unexplained weight loss
  16. Bladder or bowel dysfunction
  17. History of carcinoma
  18. Progressive neurological deficit
  19. Disturbed gait, saddle anaesthesia Musculoskeletal related
  20. Radicular syndromes of idiopathic,metabolic, toxic, infective, demyelinating or neoplastic aetiology
  21. Patients with spondylolisthesis, spondylolysis or ankylosing spondylitis.
  22. Patients with scoliosis of 15° or more
  23. Patients with inflammatory arthritis or severe degenerative process of disc and facet
  24. Patients who have had prior spine surgery, including rhizotomy as like as, patients who are planning or have been advised to have spine surgery.

    Concomitant conditions, diseases, medications and/or clinical history

  25. Patients with any concomitant chronic disease(s) or condition(s) that may predispose them to a high probability of interfering with the completion of the follow-up of the study such as peptic ulcer, liver disease, severe coronary disease, renal disease, cancer, pregnancy, alcoholism, mental state, or other clinically significant condition
  26. Patients with history of active or suspected oesophageal, gastric, pyloric channel, or duodenal ulceration or bleeding in the last 12 weeks before the screening visit
  27. Patients requiring chronic use of analgesia for pain
  28. Patients with known allergies or hypersensitivity or intolerance to Tricortin 1000, NSAIDs and/or paracetamol, and/or to active or inactive excipients of formulation
  29. Patients in treatment with neuroleptics (antipsychotics)
  30. Patients affected by diabetic neuropathy, multiple sclerosis or Amyotrophic Lateral Sclerosis
  31. Any contraindications to either prone distraction or side posture manipulation
  32. Any contraindications as reported in the Patient Information Leaflet of Tricortin 1000 or Diclofenac sodium medicated plaster.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Flavia Baruzzi 0039 031734908 flavia.baruzzi@lbresearch.it
Contact: Emanuela Terragni 0039 031733133 emanuela.terragni@lbresearch.it
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04585334
Other Study ID Numbers  ICMJE EQ06.17.01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Fidia Farmaceutici s.p.a.
Study Sponsor  ICMJE Fidia Farmaceutici s.p.a.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Nicola Giordan Fidia Farmaceutici s.p.a.
PRS Account Fidia Farmaceutici s.p.a.
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP