NCT05204667

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

Efficacy and Safety of Different Dosage Regimens of the Combination Methocarbamol/Paracetamol in Acute Low Back Pain (LBP): MioPain Study

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 172 (actual)
• Sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Low Back Pain

Interventions

Type	Name	Description
DRUG	380 mg/300 mg comprimidos metocarbamol/paracetamol - 4 times daily	(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.
DRUG	380 mg/300 mg comprimidos metocarbamol/paracetamol - 6 times daily	(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.

Timeline

• Start date: 2021-10-07
• Primary completion: 2023-11-03
• Completion: 2024-02-28
• First posted: 2022-01-24
• Last updated: 2025-01-31

Locations

3 sites across 1 country: Italy