Efficacy of the Combination of Ibuprofen and Paracetamol in Acute Non-specific Low Back Pain

NCT05222724 | Completed Phase 4

• 2 other identifiers: 147(Z)WO201572020-005278-86
• Study Type: interventional
• Target: 176
• Locations: 2 countries
• Sites: 11

Brief Summary

The aim of the present study is to assess the efficacy and safety of paracetamol/ibuprofen Fixed Dose Combination (FDC) compared to ibuprofen in patients with uncomplicated non-specific acute low back pain after a 3-day treatment period.

Conditions

Low Back Pain

Keywords

low back pain; ibuprofen; Paracetamol; Tachifene®

Outcome Measures

Primary Outcomes (1)

• The primary endpoint will be the area under the pain intensity difference-versus-time curve of Low Back Pain scores up to 3 days of treatment

  The pain intensity difference will be considered to be the difference in VAS pain intensity between one time-point and the baseline. The sum of the pain intensity differences (SPID) will be the sum of the average of two consecutive pain intensity differences multiplied by the time-interval between two time points.

  From Day 1 up to Day 3 (±1)

Secondary Outcomes (7)

• Change in Visual Analogue Scale 0-10 cm (100 mm)

  Day 0 and Day 8 (±1)

• Change from baseline up to the end of the study in Visual Analogue Scale 0-10 cm (100 mm) score.

  From Day 0 to Day 8 (±1)

• Change from baseline up to the end of the study in the hand-to-floor distance

  Day 0, Day 4 and Day 8 (±1)

• Change from baseline up to the end of the study in the in the degree of improvement in the functional disability

  Day 0, Day 4 and Day 8 (±1)

• Change in the patients' global impression

  Day 4 and Day 8 (±1)

Study Arms (2)

Tachifene

EXPERIMENTAL

paracetamol 500 mg/ibuprofen 150 mg FDC, film-coated tablets. Two tablets 3 times daily for 3 days (i.e., every 8 hours ± 1 hour).

Drug: Tachifene

Brufen

ACTIVE COMPARATOR

ibuprofen 600 mg, film coated tablets. One tablet 3 times daily for 3 days (i.e., every 8 hours ± 1 hour).

Drug: Brufen

Interventions

Tachifene DRUG

paracetamol 500 mg/ibuprofen 150 mg FDC, film-coated tablets. Two tablets 3 times daily for 3 days (i.e., every 8 hours ± 1 hour).

Also known as: paracetamol 500 mg/ibuprofen 150 mg

Tachifene

Brufen DRUG

ibuprofen 600 mg, film coated tablets. One tablet 3 times daily for 3 days (i.e., every 8 hours ± 1 hour).

Also known as: ibuprofen 600 mg

Brufen

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 uncomplicated and localized acute low back pain or acute exacerbation of chronic low back pain (not radiating below the gluteal fold), with moderate/severe pain at baseline. Minimum VAS score ≥ 40 mm at screening visit.
• 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.
• Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption
• Lactating and pregnant women.
• Clinically significant abnormalities on physical examination, vital signs or laboratory tests at Visit 0 which in the opinion of the Investigator could interfere with the study procedures or endpoints evaluation.
• Suspicious 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 of any other Low Back Pain 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;
• history of hypersensitivity to aspirin or any other non-steroidal anti-inflammatory drugs; suspicion of inflammatory, infective or neoplastic cause of pain; non- specific back symptoms related to abdominal, pelvic or thoracic pathology sensory and/or motor deficits in lower extremities;
• history of gastroduodenal ulcer or bleeding;
• history of severe cardiac, hepatic or renal insufficiency;
• current anticoagulant therapy;
• previous treatment with anticoagulants in the seven days before the screening visit;
• concomitant use of physical or alternative therapies to treat current episode of pain;
• local steroid injection for any reasons within previous 30 days;

Sponsors & Collaborators

• Aziende Chimiche Riunite Angelini Francesco S.p.A: lead
• TFS Trial Form Support: collaborator

Study Sites (11)

Università degli Studi della Campania "Luigi Vanvitelli"

Caserta, CE, 81100, Italy

Location

Azienda Ospedaliera Universitaria Policlinico G.Rodolico

Catania, 95123, Italy

Location

Azienda Ospedaliera Universitaria Integrata di Verona

Verona, 37126, Italy

Location

In-Vivo sp z o. o.

Bydgoszcz, 85-048, Poland

Location

Przychodnia "Przy Szapitalu"

Bydgoszcz, 85-094, Poland

Location

Zespół Porani Specjalistycznych Reumed Filia nr 1 Wallenroda

Lublin, 20-607, Poland

Location

Centrum Medyczne Pratia Poznan

Skorzewo, 60-185, Poland

Location

Nasz Lekarz Przychodnie Medyczne

Torun, 87-100, Poland

Location

Centrum Medyczne AstiMed

Warsaw, 01-864, Poland

Location

Centrum Medyczne PRATIA

Warsaw, 01-868, Poland

Location

Centrum Medyczne Reuma Park

Warsaw, 02-691, Poland

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Acetaminophen; Ibuprofen

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Study Design

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

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: February 3, 2022
• Study Start: December 1, 2021
• Primary Completion: October 5, 2022
• Study Completion: October 5, 2022
• Last Updated: January 31, 2023

Record last verified: 2023-01

Locations

IT (3); PL (8)