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Different Dosage Regimens of Methocarbamol/Paracetamol in Acute Non-specific Low Back Pain. MioPain Study (MioPain)

Primary Purpose

Low Back Pain

Status
Recruiting
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
380 mg/300 mg comprimidos metocarbamol/paracetamol - 4 times daily
380 mg/300 mg comprimidos metocarbamol/paracetamol - 6 times daily
Sponsored by
Aziende Chimiche Riunite Angelini Francesco S.p.A
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring low back pain, methocarbamol, paracetamol, Robaxisal compuesto

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

-Male and female patients of any ethnic origin between 18 and 64 years of age (limits included).

-Patients with current episode of acute (pain lasting less than 6 weeks) non-specific LBP, defined as pain and discomfort, localised below the costal margin and above the inferior gluteal folds, with or without leg pain, or acute exacerbation of chronic low back pain defined with a VAS score ≥ 40 mm.

  • Patients with signs and symptoms of muscle spasm of the lumbar region, as clinically diagnosed by the Investigator.
  • Women of childbearing potential and women with no menses for a period < 12 months must have a negative pregnancy test at Visit 0 and have to agree not to start a pregnancy from the signature of the informed consent up to the Final Visit/Visit 2, using an appropriate birth control method such as combined oestrogen-progestin containing hormonal contraceptives (e.g., oral, injectable, transdermal), progestin-only hormonal contraceptives (e.g., oral, injectable, implantable), intrauterine device (IUD) or Intrauterine hormone-releasing System (IUS) in combination with male condom, bilateral tubal occlusion, vasectomised partner, sexual abstinence. The following definitions will be considered:
  • Woman of childbearing potential (WOCBP): i.e., fertile, following menarche and until becoming post-menopausal, unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
  • A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
  • Patients legally capable of giving their consent to participate in the study and available to sign and date the written Informed Consent.

Exclusion Criteria:

-1. Known hypersensitivity or allergy to the active ingredients and/or to any component of the study medications.

2. Lactating and pregnant women. 3. Clinically significant abnormalities on physical examination and vital signs at Visit 0 which in the opinion of the Investigator could interfere with the study procedures or endpoints evaluation.

4. Suspicious (according to the patient's symptoms at baseline) or confirmed COVID-19 infection at time of screening visit.

5. History of cervical, thoracic, or lumbosacral pain for ≥75% of the time in the last year, or any other LBP episode in the last 3 months that required pharmacological treatment with an opioid analgesic.

6. Patients with:

  • serious spinal pathology; spinal surgery in the year prior to screening or history of more than one spinal surgery; history of severe lumbar spinal stenosis; ankylosing spondylitis; lumbosciatalgia; herniated disc or radiculopathy; severe arthritis and osteoporosis; muscular diseases, such as myositis, poliomyelitis, muscular dystrophy and myotonia; fibromyalgia; myasthenia grave; fracture or recent history of violent trauma of the back; structural deformity of the back;
  • cancer, not in remission or in complete remission less than 1 year;
  • active influenza or other viral syndrome; immunosuppression; systematically unwell; unexplained significant weight loss;
  • women with polymenorrhea, endometriosis, ovarian cysts, uterine fibroids;
  • widespread neurological symptoms (including cauda equina syndrome) or any brain disease; ever suffered from any brain damage or have been in a coma; epilepsy or seizures;
  • active or suspected esophageal, gastric, pyloric channel, or duodenal ulceration, or bleeding in the last 30 days;
  • previous treatment with anticoagulants in the seven days before the screening visit;
  • renal and/or hepatic failure;
  • acute hepatitis;
  • cardiac or pulmonary diseases;
  • acetylsalicylic acid-triggered asthma;
  • glucose-6-phosphate dehydrogenase-deficient patients; glutathione deficiency, dehydration, chronic malnutrition; anemia.

Any other condition that, in the opinion of the Investigator, interferes with the study endpoints/procedures and does not justify the inclusion of the patient in the study.

7. Current use of full, regular, recommended doses of any skeletal muscle relaxants/non - opioid analgesics/anti-inflammatory/NSAIDs in the 6 hours prior to the screening visit. Use is forbidden for the entire trial duration.

8. Current use of full, regular, recommended doses of or any medication that can alter the perception of pain (e.g., opioids, heparinoids, psychotropic agents, anti-H1 agents or glucocorticosteroids, etc.), in the 24 hours prior to the screening visit. Use is forbidden for the entire trial duration.

Chronic intake of low doses of acetylsalicylic acid, i.e., ≤162 mg/daily, taken for at least 30 days prior to the first dose of study medication for non-analgesic reasons could be continued for the duration of the study.

9. Current use of the following medications (use is forbidden for the entire trial duration):

• systemic corticosteroids;

  • other drugs containing paracetamol;
  • central nervous system (CNS) depressants and stimulants, including barbiturates, anaesthetics, appetite suppressants, anticonvulsants and lamotrigine (with the exception of therapeutic doses of benzodiazepines used as hypnoinducers in patients stabilised for more than one month since the screening visit);
  • anticholinergic drugs; psychotropic drugs; anti-cholinesterase drugs, pyridostigmine;
  • oral anticoagulants;
  • chloramphenicol; rifampicin; zidovudine;
  • loop diuretics;
  • isoniazid; probenecid;
  • propranolol;
  • antiemetics;
  • metoclopramide; domperidone;
  • ion exchange resins (e.g. cholestyramine).

    10. Patients undergoing physiotherapy, osteopathy or chiropractic treatments aimed to reduce LBP.

    11. Patients treated with invasive procedures aimed to reduce LBP (e.g., epidural injections, spinal cord stimulation therapy).

    12. History of alcoholic/substance abuse. Use of alcohol is forbidden during the entire duration of the study.

    13. Inability to comply with the protocol requirements, instructions or study-related restrictions (i.e., uncooperative attitude, inability to return for study visits, unlikelihood of completing the clinical study); vulnerable patients (i.e., persons kept in detention).

    14. Patients involved in the conduct of the study (i.e., Investigator or his/her deputy, first grade relatives, pharmacist, assistant or other personnel).

    15. Participation to an interventional clinical trial within 3 months prior to Visit 0.

Sites / Locations

  • Azienda Sociosanitaria Ligure N. 1Recruiting
  • Azienda Sanitaria Locale Asl AlRecruiting
  • Azienda Sociosanitaria Ligure Asl 3Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Methocarbamol 380 mg/paracetamol 300 mg (4 times/day)

Methocarbamol 380 mg/paracetamol 300 mg (6 times/day)

Arm Description

Patients treated with two oral tablets of methocarbamol 380 mg/paracetamol 300 mg 4 times/day up to 7 days (i.e., every 6 hours±1 hour).

Patients treated with two oral tablets of methocarbamol 380 mg/paracetamol 300 mg 6 times/day up to 7 days (i.e., every 4 hours±1 hour).

Outcomes

Primary Outcome Measures

Time to complete releif of pain.
The Time to complete relief of pain is defined as the time when the complete pain relief is reached. A Complete pain relief is defined as a Visual Analogue Scale score ≤ 5 mm at two consecutive assessments starting from Day1 up to Day7 (±1).

Secondary Outcome Measures

Change in Low Back Pain intensity at Visit 0 and Visit 1
Change in Low Back Pain intensity at Visit 0 and Visit 1, measured by 0-10 cm (100 mm) Visual Analogue Scale, stretching from 0 "no pain" to 10 "pain as bad as it could be".
Change in Low Back Pain intensity at Visit 0 and Final Visit
Change in Low Back Pain intensity at Visit 0 and Final Visit, measured by 0-10 cm (100 mm) Visual Analogue Scale, stretching from 0 "no pain" to 10 "pain as bad as it could be".
Change in the degree of improvement in the hand-to-floor distance
The Hand-to-floor distance, also called fingertip-to-floor test or mobility assessment is the vertical distance between the tip of the middle finger and the floor measured by a simple cm graduated bar (0 value at floor). The patient will be asked to bend forward as far as possible and try to touch the floor with his/her fingers, while maintaining the knees, arms, and fingers fully extended.
Change in the functional disability
The Functional disability is assessed by the Oswestry Disability Index (ODI) that allows to obtain information on how acute Low Back Pain affects ability to manage patients Activities of Daily Living (ADL). The Oswestry Disability Index contains 10 sections. For each section the total possible score is 5: if the first statement is marked, the section score is=0; if the last statement is marked, it is=5. The total score of all sections as a percentage of the total achievable score is the Oswestry Disability Index score.
Change in the Patients' Global Impression of Change scale score
The Patients' Global Impression of Change (PGIC) scale reflects a patient's belief about the efficacy of treatment evaluating all aspects of patient's health and quality of life (QoL). It is a 7-point scale depicting a patient's rating of overall improvement: "no change", "almost the same", "a little better", "somewhat better", "moderately better", "better", or "a great deal better".
Change in the Clinical Global Impression-Improvement scale score
The Clinical Global Impression-Improvement (CGI-I) scale provides an overall clinician-determined summary evaluation of the treatment. It is a 7-point scale: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from the initiation of treatment; 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment.
Monitoring frequency of adverse events (AEs)
Safety will be assessed by monitoring the frequency of adverse events in each treatment group. All AEs will be coded using MedDRA (Medical Dictionary for Regulatory Activities).

Full Information

First Posted
December 14, 2021
Last Updated
October 20, 2023
Sponsor
Aziende Chimiche Riunite Angelini Francesco S.p.A
Collaborators
Hippocrates Research
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1. Study Identification

Unique Protocol Identification Number
NCT05204667
Brief Title
Different Dosage Regimens of Methocarbamol/Paracetamol in Acute Non-specific Low Back Pain. MioPain Study
Acronym
MioPain
Official Title
Efficacy and Safety of Different Dosage Regimens of the Combination Methocarbamol/Paracetamol in Acute Low Back Pain (LBP): MioPain Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 7, 2021 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aziende Chimiche Riunite Angelini Francesco S.p.A
Collaborators
Hippocrates Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of the study is to evaluate the efficacy and safety of different dosage regimens of the combination methocarbamol/paracetamol in the treatment of patients with acute non-specific Low Back Pain.
Detailed Description
This is a Phase IV, randomized, open-label, parallel-group, multicentre study. A total of 192 patients of both sexes will be enrolled in the study and will be randomized 1:1 to one of the following 2 treatment groups: Group 1: methocarbamol 380 mg/paracetamol 300 mg (2 oral tablets 4 times/day) Group 2: methocarbamol 380 mg/paracetamol 300 mg (2 oral tablets 6 times/day) The expected duration of patient participation into the trial (from ICF signature up to any applicable follow up) is 8 days (± 1). Patients enrolment will be competitive among clinical sites. The primary endpoint will be the Time to complete relief of pain, defined as the time when the complete pain relief is reached. A Complete pain relief is defined as a VAS score ≤ 5 mm at two consecutive assessments starting from Day1 up to Day7 (±1).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
low back pain, methocarbamol, paracetamol, Robaxisal compuesto

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
This is a Phase IV, randomized, open-label, parallel-group, multicentre study.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
192 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Methocarbamol 380 mg/paracetamol 300 mg (4 times/day)
Arm Type
Experimental
Arm Description
Patients treated with two oral tablets of methocarbamol 380 mg/paracetamol 300 mg 4 times/day up to 7 days (i.e., every 6 hours±1 hour).
Arm Title
Methocarbamol 380 mg/paracetamol 300 mg (6 times/day)
Arm Type
Active Comparator
Arm Description
Patients treated with two oral tablets of methocarbamol 380 mg/paracetamol 300 mg 6 times/day up to 7 days (i.e., every 4 hours±1 hour).
Intervention Type
Drug
Intervention Name(s)
380 mg/300 mg comprimidos metocarbamol/paracetamol - 4 times daily
Other Intervention Name(s)
Robaxisal compuesto
Intervention Description
(2 oral tablets 4 times/day up to 7 days (i.e., every 6 hours±1 hour). Ingestion of the tablets can be helped with a small amount of water.
Intervention Type
Drug
Intervention Name(s)
380 mg/300 mg comprimidos metocarbamol/paracetamol - 6 times daily
Other Intervention Name(s)
Robaxisal compuesto
Intervention Description
(2 oral tablets 6 times/day up to 7 days (i.e., every 4 hours±1 hour). Ingestion of the tablets can be helped with a small amount of water.
Primary Outcome Measure Information:
Title
Time to complete releif of pain.
Description
The Time to complete relief of pain is defined as the time when the complete pain relief is reached. A Complete pain relief is defined as a Visual Analogue Scale score ≤ 5 mm at two consecutive assessments starting from Day1 up to Day7 (±1).
Time Frame
from Day1 up to Day7 (±1).
Secondary Outcome Measure Information:
Title
Change in Low Back Pain intensity at Visit 0 and Visit 1
Description
Change in Low Back Pain intensity at Visit 0 and Visit 1, measured by 0-10 cm (100 mm) Visual Analogue Scale, stretching from 0 "no pain" to 10 "pain as bad as it could be".
Time Frame
Day 0 and Day 4 (±1).
Title
Change in Low Back Pain intensity at Visit 0 and Final Visit
Description
Change in Low Back Pain intensity at Visit 0 and Final Visit, measured by 0-10 cm (100 mm) Visual Analogue Scale, stretching from 0 "no pain" to 10 "pain as bad as it could be".
Time Frame
Day 0 and Day 8 (±1).
Title
Change in the degree of improvement in the hand-to-floor distance
Description
The Hand-to-floor distance, also called fingertip-to-floor test or mobility assessment is the vertical distance between the tip of the middle finger and the floor measured by a simple cm graduated bar (0 value at floor). The patient will be asked to bend forward as far as possible and try to touch the floor with his/her fingers, while maintaining the knees, arms, and fingers fully extended.
Time Frame
Day 0, Day 4 and Day 8 (±1).
Title
Change in the functional disability
Description
The Functional disability is assessed by the Oswestry Disability Index (ODI) that allows to obtain information on how acute Low Back Pain affects ability to manage patients Activities of Daily Living (ADL). The Oswestry Disability Index contains 10 sections. For each section the total possible score is 5: if the first statement is marked, the section score is=0; if the last statement is marked, it is=5. The total score of all sections as a percentage of the total achievable score is the Oswestry Disability Index score.
Time Frame
Day 0, Day 4 and Day 8 (±1).
Title
Change in the Patients' Global Impression of Change scale score
Description
The Patients' Global Impression of Change (PGIC) scale reflects a patient's belief about the efficacy of treatment evaluating all aspects of patient's health and quality of life (QoL). It is a 7-point scale depicting a patient's rating of overall improvement: "no change", "almost the same", "a little better", "somewhat better", "moderately better", "better", or "a great deal better".
Time Frame
Day 0 and Day 8 (±1).
Title
Change in the Clinical Global Impression-Improvement scale score
Description
The Clinical Global Impression-Improvement (CGI-I) scale provides an overall clinician-determined summary evaluation of the treatment. It is a 7-point scale: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from the initiation of treatment; 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment.
Time Frame
Day 0 and Day 8 (±1).
Title
Monitoring frequency of adverse events (AEs)
Description
Safety will be assessed by monitoring the frequency of adverse events in each treatment group. All AEs will be coded using MedDRA (Medical Dictionary for Regulatory Activities).
Time Frame
8 (±1) days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: -Male and female patients of any ethnic origin between 18 and 64 years of age (limits included). -Patients with current episode of acute (pain lasting less than 6 weeks) non-specific LBP, defined as pain and discomfort, localised below the costal margin and above the inferior gluteal folds, with or without leg pain, or acute exacerbation of chronic low back pain defined with a VAS score ≥ 40 mm. Patients with signs and symptoms of muscle spasm of the lumbar region, as clinically diagnosed by the Investigator. Women of childbearing potential and women with no menses for a period < 12 months must have a negative pregnancy test at Visit 0 and have to agree not to start a pregnancy from the signature of the informed consent up to the Final Visit/Visit 2, using an appropriate birth control method such as combined oestrogen-progestin containing hormonal contraceptives (e.g., oral, injectable, transdermal), progestin-only hormonal contraceptives (e.g., oral, injectable, implantable), intrauterine device (IUD) or Intrauterine hormone-releasing System (IUS) in combination with male condom, bilateral tubal occlusion, vasectomised partner, sexual abstinence. The following definitions will be considered: Woman of childbearing potential (WOCBP): i.e., fertile, following menarche and until becoming post-menopausal, unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. Patients legally capable of giving their consent to participate in the study and available to sign and date the written Informed Consent. Exclusion Criteria: -1. Known hypersensitivity or allergy to the active ingredients and/or to any component of the study medications. 2. Lactating and pregnant women. 3. Clinically significant abnormalities on physical examination and vital signs at Visit 0 which in the opinion of the Investigator could interfere with the study procedures or endpoints evaluation. 4. Suspicious (according to the patient's symptoms at baseline) or confirmed COVID-19 infection at time of screening visit. 5. History of cervical, thoracic, or lumbosacral pain for ≥75% of the time in the last year, or any other LBP episode in the last 3 months that required pharmacological treatment with an opioid analgesic. 6. Patients with: serious spinal pathology; spinal surgery in the year prior to screening or history of more than one spinal surgery; history of severe lumbar spinal stenosis; ankylosing spondylitis; lumbosciatalgia; herniated disc or radiculopathy; severe arthritis and osteoporosis; muscular diseases, such as myositis, poliomyelitis, muscular dystrophy and myotonia; fibromyalgia; myasthenia grave; fracture or recent history of violent trauma of the back; structural deformity of the back; cancer, not in remission or in complete remission less than 1 year; active influenza or other viral syndrome; immunosuppression; systematically unwell; unexplained significant weight loss; women with polymenorrhea, endometriosis, ovarian cysts, uterine fibroids; widespread neurological symptoms (including cauda equina syndrome) or any brain disease; ever suffered from any brain damage or have been in a coma; epilepsy or seizures; active or suspected esophageal, gastric, pyloric channel, or duodenal ulceration, or bleeding in the last 30 days; previous treatment with anticoagulants in the seven days before the screening visit; renal and/or hepatic failure; acute hepatitis; cardiac or pulmonary diseases; acetylsalicylic acid-triggered asthma; glucose-6-phosphate dehydrogenase-deficient patients; glutathione deficiency, dehydration, chronic malnutrition; anemia. Any other condition that, in the opinion of the Investigator, interferes with the study endpoints/procedures and does not justify the inclusion of the patient in the study. 7. Current use of full, regular, recommended doses of any skeletal muscle relaxants/non - opioid analgesics/anti-inflammatory/NSAIDs in the 6 hours prior to the screening visit. Use is forbidden for the entire trial duration. 8. Current use of full, regular, recommended doses of or any medication that can alter the perception of pain (e.g., opioids, heparinoids, psychotropic agents, anti-H1 agents or glucocorticosteroids, etc.), in the 24 hours prior to the screening visit. Use is forbidden for the entire trial duration. Chronic intake of low doses of acetylsalicylic acid, i.e., ≤162 mg/daily, taken for at least 30 days prior to the first dose of study medication for non-analgesic reasons could be continued for the duration of the study. 9. Current use of the following medications (use is forbidden for the entire trial duration): • systemic corticosteroids; other drugs containing paracetamol; central nervous system (CNS) depressants and stimulants, including barbiturates, anaesthetics, appetite suppressants, anticonvulsants and lamotrigine (with the exception of therapeutic doses of benzodiazepines used as hypnoinducers in patients stabilised for more than one month since the screening visit); anticholinergic drugs; psychotropic drugs; anti-cholinesterase drugs, pyridostigmine; oral anticoagulants; chloramphenicol; rifampicin; zidovudine; loop diuretics; isoniazid; probenecid; propranolol; antiemetics; metoclopramide; domperidone; ion exchange resins (e.g. cholestyramine). 10. Patients undergoing physiotherapy, osteopathy or chiropractic treatments aimed to reduce LBP. 11. Patients treated with invasive procedures aimed to reduce LBP (e.g., epidural injections, spinal cord stimulation therapy). 12. History of alcoholic/substance abuse. Use of alcohol is forbidden during the entire duration of the study. 13. Inability to comply with the protocol requirements, instructions or study-related restrictions (i.e., uncooperative attitude, inability to return for study visits, unlikelihood of completing the clinical study); vulnerable patients (i.e., persons kept in detention). 14. Patients involved in the conduct of the study (i.e., Investigator or his/her deputy, first grade relatives, pharmacist, assistant or other personnel). 15. Participation to an interventional clinical trial within 3 months prior to Visit 0.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carmelina Valerio
Phone
+39 0691045567
Email
carmelina.valerio@angelinipharma.com
First Name & Middle Initial & Last Name or Official Title & Degree
Enrica Salvatori
Phone
+39 0691045321
Email
enrica.salvatori@angelinipharma.com
Facility Information:
Facility Name
Azienda Sociosanitaria Ligure N. 1
City
Sanremo
State/Province
Imperia
ZIP/Postal Code
18038
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Riccardo Agati
First Name & Middle Initial & Last Name & Degree
Fulvio Albè
First Name & Middle Initial & Last Name & Degree
Giovanni Amoretti
First Name & Middle Initial & Last Name & Degree
Roberto Buccelli
First Name & Middle Initial & Last Name & Degree
Walter Dirienzo
First Name & Middle Initial & Last Name & Degree
Francesco Gatani
First Name & Middle Initial & Last Name & Degree
Germano Mondino
First Name & Middle Initial & Last Name & Degree
Ettore Perreca
First Name & Middle Initial & Last Name & Degree
Michele Pinelli
Facility Name
Azienda Sanitaria Locale Asl Al
City
Alessandria
ZIP/Postal Code
15121
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Moreno Ferrarese
First Name & Middle Initial & Last Name & Degree
Elisabetta Accettone
First Name & Middle Initial & Last Name & Degree
Aldo Alpa
First Name & Middle Initial & Last Name & Degree
Pierfranco Bianchi
First Name & Middle Initial & Last Name & Degree
Esther Botto
First Name & Middle Initial & Last Name & Degree
Gabriella Camurati
First Name & Middle Initial & Last Name & Degree
Enrico Crosio
First Name & Middle Initial & Last Name & Degree
Gian Erminio Dagna
First Name & Middle Initial & Last Name & Degree
Pietro Gazzaniga
First Name & Middle Initial & Last Name & Degree
Daniela Lanzavecchia
First Name & Middle Initial & Last Name & Degree
Fabio Maccapani
First Name & Middle Initial & Last Name & Degree
Sara Marasso
First Name & Middle Initial & Last Name & Degree
Sara Moretti
First Name & Middle Initial & Last Name & Degree
Giulia Oddino
First Name & Middle Initial & Last Name & Degree
Angelo Raccone
First Name & Middle Initial & Last Name & Degree
Alessandra Reposi
First Name & Middle Initial & Last Name & Degree
Davide Saccone
First Name & Middle Initial & Last Name & Degree
Federico Torreggiani
Facility Name
Azienda Sociosanitaria Ligure Asl 3
City
Genova
ZIP/Postal Code
16125
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alberto Saccarello
First Name & Middle Initial & Last Name & Degree
Pierclaudio Brasesco
First Name & Middle Initial & Last Name & Degree
Andrea Carraro
First Name & Middle Initial & Last Name & Degree
Roberto Castagnaro
First Name & Middle Initial & Last Name & Degree
Marco Grosso
First Name & Middle Initial & Last Name & Degree
Vittorio Guida
First Name & Middle Initial & Last Name & Degree
Marco Malatesta
First Name & Middle Initial & Last Name & Degree
Riccardo Masserano
First Name & Middle Initial & Last Name & Degree
Andrea Pedemonte
First Name & Middle Initial & Last Name & Degree
Paolo Picco
First Name & Middle Initial & Last Name & Degree
Rinaldo Picciotto
First Name & Middle Initial & Last Name & Degree
Luca Spigno

12. IPD Sharing Statement

Learn more about this trial

Different Dosage Regimens of Methocarbamol/Paracetamol in Acute Non-specific Low Back Pain. MioPain Study

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