Efficacy and Safety of Fixed-dose Combination of Etoricoxib/Tramadol vs Acetaminophen/Tramadol for Acute Low Back Pain

NCT04968158 | Completed Phase 3

• 1 other identifier: SIL-30138-III-21(1)
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

Phase IIIb, longitudinal, multicenter, randomized, open-label clinical trial to evaluate the efficacy and safety of the fixed-dose combination of etoricoxib 90 mg and tramadol 50 mg compared with fixed-dose therapy of acetaminophen 325 mg and tramadol 37.5 mg for the management of acute low back pain.

Conditions

Acute Low Back Pain

Keywords

Back pain; Etoricoxib; Tramadol; Fixed dose

Outcome Measures

Primary Outcomes (1)

• Average change in reported pain

  Compare the average change in pain reported through the VAS (Visual Analog Scale) per treatment group. In a straight 10 centimeter line in which one end means no pain and the other end means the worst pain imaginable, the participants mark the amount of pain feeling at that moment

  Baseline, 3, 5 and 7 days.

Secondary Outcomes (4)

• Proportion of patients with a 30% reduction in pain intensity

  Baseline and 7 days.

• Degree of disability due to low back pain

  Baseline and 7 days.

• Degree of inability to perform daily activities

  Baseline and 7 days.

• Adverse events

  7 days.

Study Arms (2)

Group A: Etoricoxib/Tramadol

EXPERIMENTAL

Administered orally, one packet of etoricoxib / tramadol granules diluted in 100 ml of water, every 24 hours for 7 days.

Drug: Etoricoxib 90 mg / Tramadol 50 mg

Group B: Acetaminophen / Tramadol

ACTIVE COMPARATOR

Administered orally, one tablet, every 8 hours, for 7 days.

Drug: Acetaminophen 325 mg / Tramadol 37.5 mg

Interventions

Etoricoxib 90 mg / Tramadol 50 mg DRUG

One packet diluted in 100 ml of water, every 24 hours of 90 mg/50 mg.

Also known as: E/T

Group A: Etoricoxib/Tramadol

Acetaminophen 325 mg / Tramadol 37.5 mg DRUG

One tablet, every 8 hours of 325 mg/ 37.5 m

Also known as: A/T

Group B: Acetaminophen / Tramadol

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Any sex.
• That the subject agree to participate in the study and give informed consent in writing.
• Age\> 18 years and ≤ 60 years of age at the beginning of the study.
• Diagnosis of acute low back pain as a first-time episode or after another episode, maximum 6 months before and lasting no more than 6 weeks.
• Patient with low back pain reported as moderate to severe intensity (VAS\> 4 cm).
• Women of childbearing age who have an acceptable contraceptive method (eg barrier, oral hormonal, injectable, subdermal).

You may not qualify if:

• Patients in whom the study drug is contraindicated for medical reasons.
• Patients with an allergy or hypersensitivity to the active principle, study drugs, related products or excipients.
• Positive pregnancy test, women who are pregnant, breastfeeding or planning a pregnancy while conducting the study.
• A significant history of gastrointestinal disorders (for example: Gastric ulcer, Crohn's disease, Ulcerative Colitis, etc.).
• Previous treatment with opioids and / or NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) reported in the medical history in the last 72 hours at study entry.
• Patients with a history of alcohol or drug abuse in the last year according to DSM-V (Diagnostic and Statistical Manual of Mental Disorders).
• Patients who are receiving monoamine oxidase inhibitors (MAOIs) or who have received them within the past 2 weeks.
• Patients with a history of established ischemic heart disease, peripheral arterial disease and / or cerebrovascular disease (including patients who have recently undergone coronary artery bypass grafting or angioplasty).
• Patients with status epileptic seizure disorders and grand mal seizures.
• Patients with a history of severe acute or chronic liver failure.
• Patients with a history of moderate to severe renal failure.
• Patient with a history of chronic pain (eg, fibromyalgia, Paget's disease, bone pain induced by metastatic cancer).
• Low back pain due to major trauma (eg vertebral fracture, post-traumatic spondylolisthesis), or due to a visceral disorder (eg dysmenorrhea, endometriosis).
• At medical criteria, a disease that affects the prognosis and prevents outpatient management, for example, but not restricted to: intestinal obstruction, paralytic ileus, end-stage cancer, kidney, heart, respiratory or liver failure or mental illness or with surgical procedures or scheduled hospitals.
• History / presence of any disease or condition that, in the Investigator's opinion, could pose a risk to the patient or confuse the efficacy and safety of the study results. ----Patients with symptoms suggesting an active COVID-19 infection (i.e., fever, cough, dyspnea) and / or contact in the past 14 days with a suspected or positive COVID-19 patient.

Sponsors & Collaborators

• Laboratorios Silanes S.A. de C.V.: lead

Study Sites (1)

Laboratorio Silanes, S.A. de C.V.

Mexico City, 11000, Mexico

Location

Related Publications (10)

• GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018 Nov 10;392(10159):1789-1858. doi: 10.1016/S0140-6736(18)32279-7. Epub 2018 Nov 8.

  PMID: 30496104 BACKGROUND

• Soto-Padilla M, Espinosa-Mendoza RL, Sandoval-Garcia JP, Gomez-Garcia F. [Comparative study between plate-graft, cage-plate and peek cage in cervical arthrodesis for cervical stenosis]. Acta Ortop Mex. 2015 Jan-Feb;29(1):40-5. Spanish.

  PMID: 26999925 BACKGROUND

• Casser HR, Seddigh S, Rauschmann M. Acute Lumbar Back Pain. Dtsch Arztebl Int. 2016 Apr 1;113(13):223-34. doi: 10.3238/arztebl.2016.0223.

  PMID: 27120496 BACKGROUND

• Guevara-Lopez U, Covarrubias-Gomez A, Elias-Dib J, Reyes-Sanchez A, Rodriguez-Reyna TS; Consensus Group of Practice Parameters to Manage Low Back Pain. Practice guidelines for the management of low back pain. Consensus Group of Practice Parameters to Manage Low Back Pain. Cir Cir. 2011 May-Jun;79(3):264-79, 286-302. English, Spanish.

  PMID: 22381000 BACKGROUND

• Gonzalez Maza C, Moscoso Lopez L, Ramirez Elizalde G, Abdo Andrade A. [Multimodal treatment of chronic unspecific low back pain]. Acta Ortop Mex. 2010 Mar-Apr;24(2):88-94. Spanish.

  PMID: 20831016 BACKGROUND

• Chandanwale AS, Sundar S, Latchoumibady K, Biswas S, Gabhane M, Naik M, Patel K. Efficacy and safety profile of combination of tramadol-diclofenac versus tramadol-paracetamol in patients with acute musculoskeletal conditions, postoperative pain, and acute flare of osteoarthritis and rheumatoid arthritis: a Phase III, 5-day open-label study. J Pain Res. 2014 Aug 12;7:455-63. doi: 10.2147/JPR.S67817. eCollection 2014.

  PMID: 25152629 BACKGROUND

• Bravo L, Mico JA, Berrocoso E. Discovery and development of tramadol for the treatment of pain. Expert Opin Drug Discov. 2017 Dec;12(12):1281-1291. doi: 10.1080/17460441.2017.1377697. Epub 2017 Sep 17.

  PMID: 28920461 BACKGROUND

• Dhillon S. Tramadol/paracetamol fixed-dose combination: a review of its use in the management of moderate to severe pain. Clin Drug Investig. 2010;30(10):711-38. doi: 10.2165/11205830-000000000-00000.

  PMID: 20701403 BACKGROUND

• Subedi M, Bajaj S, Kumar MS, Yc M. An overview of tramadol and its usage in pain management and future perspective. Biomed Pharmacother. 2019 Mar;111:443-451. doi: 10.1016/j.biopha.2018.12.085. Epub 2018 Dec 27.

  PMID: 30594783 BACKGROUND

• Zuqui-Ramirez MA, Belalcazar-Lopez VM, Urenda-Quezada A, Gonzalez-Rebatu Y Gonzalez A, Sander-Padilla JG, Lugo-Sanchez LA, Rodriguez-Vazquez IC, Rios-Brito KF, Arguedas-Nunez MM, Canales-Vazquez E, Gonzalez-Canudas J. Multimodal Analgesia Approach in Acute Low Back Pain Management: A Phase III Study of a Novel Analgesic Combination of Etoricoxib/Tramadol. Pain Ther. 2024 Dec;13(6):1511-1528. doi: 10.1007/s40122-024-00653-y. Epub 2024 Sep 10.

  PMID: 39256291 DERIVED

Related Links

• World Health Organization. Musculoskeletal disorders \[Internet\]. Descriptive notes. 2019.
• "That establishes the tests and procedures to demonstrate that a drug is interchangeable. Requirements to which the Authorized Third Parties that carry out the interchangeability tests must be ".
• "Installation and operation of pharmacovigilance: This document establishes the guidelines on which pharmacovigilance activities must be carried out"
• "That establishes the criteria for the execution of research projects for health in human beings"

MeSH Terms

Conditions

Back Pain

Interventions

Etoricoxib; Tramadol; Acetaminophen

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Sulfones; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Dimethylamines; Methylamines; Amines; Lipids; Acetanilides; Anilides; Amides; Aniline Compounds

Study Officials

• Miguel A Zurqui Ramírez, M.D

  Icaro Investigación en Medicina S.A. de C.V.

  PRINCIPAL INVESTIGATOR

• Adelfia Urenda Quezada, M.D

  Mediadvance Clinical S.A.P.I. de Quezada

  PRINCIPAL INVESTIGATOR

• Alejandro González Rebatu y González, M.D

  Clinical Research Institute S.C.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: July 20, 2021
• Study Start: November 29, 2021
• Primary Completion: March 15, 2022
• Study Completion: April 10, 2022
• Last Updated: April 13, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)