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

NCT05204667 | Terminated Phase 4

• 2 other identifiers: 044(10A)MD202942021-000067-68
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 3

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.

Conditions

Low Back Pain

Keywords

low back pain; methocarbamol; paracetamol; Robaxisal compuesto

Outcome Measures

Primary Outcomes (1)

• 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).

  from Day1 up to Day7 (±1).

Secondary Outcomes (7)

• Change in Low Back Pain intensity at Visit 0 and Visit 1

  Day 0 and Day 4 (±1).

• Change in Low Back Pain intensity at Visit 0 and Final Visit

  Day 0 and Day 8 (±1).

• Change in the degree of improvement in the hand-to-floor distance

  Day 0, Day 4 and Day 8 (±1).

• Change in the functional disability

  Day 0, Day 4 and Day 8 (±1).

• Change in the Patients' Global Impression of Change scale score

  Day 0 and Day 8 (±1).

Study Arms (2)

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

EXPERIMENTAL

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).

Drug: 380 mg/300 mg comprimidos metocarbamol/paracetamol - 4 times daily

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

ACTIVE COMPARATOR

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).

Drug: 380 mg/300 mg comprimidos metocarbamol/paracetamol - 6 times daily

Interventions

380 mg/300 mg comprimidos metocarbamol/paracetamol - 4 times daily DRUG

(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.

Also known as: Robaxisal compuesto

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

380 mg/300 mg comprimidos metocarbamol/paracetamol - 6 times daily DRUG

(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.

Also known as: Robaxisal compuesto

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

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Known hypersensitivity or allergy to the active ingredients and/or to any component of the study medications.
• \. 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.
• \. Suspicious (according to the patient's symptoms at baseline) or confirmed COVID-19 infection at time of screening visit.
• \. 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.
• \. 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;

Sponsors & Collaborators

• Aziende Chimiche Riunite Angelini Francesco S.p.A: lead
• Hippocrates Research: collaborator

Study Sites (3)

Azienda Sociosanitaria Ligure N. 1

Sanremo, Imperia, 18038, Italy

Location

Azienda Sanitaria Locale Asl Al

Alessandria, 15121, Italy

Location

Azienda Sociosanitaria Ligure Asl 3

Genova, 16125, Italy

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a Phase IV, randomized, open-label, parallel-group, multicentre study.

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: January 24, 2022
• Study Start: October 7, 2021
• Primary Completion: November 3, 2023
• Study Completion: February 28, 2024
• Last Updated: January 31, 2025

Record last verified: 2025-01

Locations

IT (3)