Low Back Pain, MechanicalPhase 4NCT04585334
Effectiveness of Tricortin 1000 in Patients Affected by Chronic Low Back Pain
A Phase 4 study testing Tricortin 1000 and Itami in people with Low Back Pain, Mechanical, run by Fidia Farmaceutici s.p.a. at 13 sites in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Low Back Pain, Mechanical
- What is being tested?
- Tricortin 1000 and Itami
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 13 sitesItaly
- Study dates
- 25 Mar 2019to Jan 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
- Baseline Inclusion Criteria:
- 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.
- 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
- 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 2
Who cannot join
- 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
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- 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
- Any recent trauma, which may raise the possibility of a fracture
- Fever and unexplained weight loss
- Bladder or bowel dysfunction
- History of carcinoma
- Progressive neurological deficit
- Disturbed gait, saddle anaesthesia Musculoskeletal related
- Radicular syndromes of idiopathic,metabolic, toxic, infective, demyelinating or neoplastic aetiology
- Patients with spondylolisthesis, spondylolysis or ankylosing spondylitis.
- Patients with scoliosis of 15° or more
- Patients with inflammatory arthritis or severe degenerative process of disc and facet
- 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
- 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
- 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
- Patients requiring chronic use of analgesia for pain
- Patients with known allergies or hypersensitivity or intolerance to Tricortin 1000, NSAIDs and/or paracetamol, and/or to active or inactive excipients of formulation
- Patients in treatment with neuroleptics (antipsychotics)
- Patients affected by diabetic neuropathy, multiple sclerosis or Amyotrophic Lateral Sclerosis
- Any contraindications to either prone distraction or side posture manipulation
- Any contraindications as reported in the Patient Information Leaflet of Tricortin 1000 or Diclofenac sodium medicated plaster.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Italy13 sites, 13 recruiting
- Recruiting
ATS Insubria
Alzate Brianza, 22040
Paolo Tornari
- Recruiting
UOC Medicina Fisica e Riabilitazione - Unità Spinale Unipolare, Azienda OU "Consorziale Policlinico" Bari
Bari, 70125
Marisa Megna
- Recruiting
Servizio di Medicina Fisica e Riabilitativa, AOU Policlinico-P.O.G. Rodolico
Catania, 95123
Michele Vecchio
- Recruiting
U.O. Medicina Fisica e Riabilitativa Azienda ospedaliera Mater Domini
Catanzaro, 88100
Antonio Ammendolia
- Recruiting
ATS Insubria
Como, 22100
Maurizio Mancuso
- Recruiting
ATS Insubria
Erba, 22036
Alberto Rigamonti
- Recruiting
SODC-Riabilitazione Azienda ospedaliero-Universitaria Careggi- Ospedale Careggi
Florence, 50139
Giuseppe Falcone
- Recruiting
U.O.C. di Riabilitazione Ortopedica, Azienda Ospedaliera Universitaria di Padova
Padova, 35128
Stefano Masiero
- Recruiting
U.O.C. di Riabilitazione AOU Policlinico P. Giaccone
Palermo, 90127
Giulia Letizia Mauro
- Recruiting
ATS Insubria
Porlezza, Como, 22018
Attilio Giossi
- Recruiting
U.O.C. Medicina Fisica Riabilitativa Azienda Policlinoc Umberto I, Università di Roma La Sapienza
Roma, 00185
Valter Santilli
- Recruiting
UOS Medicina Fisica e Riabilitativa Azienda Ospedaliero Universitaria Sant'Andrea-Roma
Roma, 00189
Maria Chiara Vulpiani
- Recruiting
U.O.C. Neuroriabilitazione, Dipartimento di Neuroscienze, Azienda Ospedaliera Universitaria Integrata di Verona, Policlinico Borgo Roma
Verona, 37134
Nicola Smania
About this study
Official title: 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
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).
Read the 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:
- Tricortin 1000 by intramuscular route (Arm A)
- Diclofenac sodium medicated plaster by topical application (Arm B)
- 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
- Being tested
- Tricortin 1000, Itami, Placebo
- Keywords
- Chronic, Degenerative process of disc and facet
- Medical subject headings
- Low Back Pain, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tricortin 1000Drug
Also called Tricortin
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.
ItamiDrug
Also called Diclofenac sodium 140 mg medicated plaster
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).
PlaceboDrug
Also called Placebo plaster and Tricortin 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.
| Study group | Role | What they receive |
|---|---|---|
| Arm A Tricortin | Experimental | Tricortin 1000 by intramuscular route Receives: Drug: Tricortin 1000 |
| Arm B Itami | Active comparator | Itami Diclofenac sodium medicated plaster by topical application Receives: Drug: Itami |
| Arm C Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
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. (0-10 points Numerical Rating Scale for pain, where score 0 corresponds to no pain and score 10 corresponds to unimaginable pain)
Measured: Day 15
Functional disability improvement as change from baseline to 15 days through the Oswestry Low Back Pain Disability Index (ODI), version 2.1a
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.
Measured: Day 0, Day 7 and Day 15
Clinical improvement as change from baseline to 15 days
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.
Measured: 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
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
Measured: 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
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
Measured: Day 0, Day7 and Day 15
Consumption of rescue medication as change from baseline to 15 days using a patient diary (maximum 4 tablets for 4 days/week)
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
Measured: From Day -14 to Day 15
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)
To compare Tricortin 1000 with placebo and diclofenac sodium medicated plaster in patient safety as change from baseline to 15 days.
Measured: From Day -14 to Day 15
Safety as change from baseline to 15 days evaluated by vital signs (systolic blood pressure, diastolic blood pressure, heart rate)
To compare Tricortin 1000 with placebo and diclofenac sodium medicated plaster in patient safety as change from baseline to 15 days.
Measured: From Day -14 to Day 15
Safety as change from baseline to 15 days evaluated by tracking the number of patient withdrawals and their adverse events
To compare Tricortin 1000 with placebo and diclofenac sodium medicated plaster in patient safety as change from baseline to 15 days.
Measured: From Day -14 to Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start25 Mar 2019
- Primary completionDec 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back Pain, MechanicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- PAES, double blind, double dummy, multicenter, randomized, controlled clinical study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fidia Farmaceutici s.p.a.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicola Giordan, Study director, Fidia Farmaceutici s.p.a.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04585334
- Sponsor's protocol ID
- EQ06.17.01
- Status last verified
- Oct 2023
- First submitted
- 2 Mar 2020
- Last updated
- 27 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04585334
- Acronym / sponsor ID
- EQ06.17.01
- Conditions
- Low Back Pain, Mechanical
- Keywords
- Chronic, Degenerative process of disc and facet
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fidia Farmaceutici s.p.a.Industry (pharma, biotech, devices)
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Tricortin 1000 by intramuscular route (Arm A)
- Diclofenac sodium medicated plaster by topical application (Arm B)
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- PAES, double blind, double dummy, multicenter, randomized, controlled clinical study
| Arm | Type | Receives |
|---|---|---|
| Arm A Tricortin | Experimental | Drug: Tricortin 1000Tricortin 1000 by intramuscular route |
| Arm B Itami | Active comparator | Drug: ItamiItami Diclofenac sodium medicated plaster by topical application |
| Arm C Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (35 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tricortin 1000Also: TricortinTricortin 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 | Arm A Tricortin |
| ItamiAlso: Diclofenac sodium 140 mg medicated plasterDiclofenac 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 | Arm B Itami |
| PlaceboAlso: Placebo plaster and Tricortin placeboTricortin 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. | Drug | Arm C Placebo |
Primary outcome
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
Time frame: Day 15
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)
9 secondary outcomes
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
Time frame: Day 15
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
Clinical improvement as change from baseline to 15 days
Time frame: 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
Time frame: 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
Time frame: Day 0, Day7 and 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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicola Giordan study director
Fidia Farmaceutici s.p.a.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tricortin 1000 and Itami in people with Low Back Pain, Mechanical, run by Fidia Farmaceutici s.p.a. at 13 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Flavia Baruzzi (0039 031734908, flavia.baruzzi@lbresearch.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Day 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2023.