Efficacy and Safety of Etoricoxib/Cyanocobalamin Versus Etoricoxib for Acute Low Back Pain

NCT06517823 | Completed Phase 3 DMC

• 1 other identifier: SIL-30952-III-23(1)
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief Summary

Phase III longitudinal, multicenter, randomized, double-blind clinical trial. The aim of this study is to evaluate the efficacy and safety of the Fixed-Dose Combination of Etoricoxib/Cyanocobalamin Versus Etoricoxib in Patients With Acute Low Back Pain

Conditions

Acute Low-back Pain

Keywords

Acute Low -back Pain; Acute pain; Etoricoxib; Cyanocobalamin

Outcome Measures

Primary Outcomes (2)

• Comparison of the proportion of patients reporting pain improvement (reduction in pain intensity with a VAS ≤20 mm) at 1, 3, 5, and 7 days of follow-up, according to their baseline measurement in each treatment group

  The visual analog pain scale (VAS) is a straight line in which one end signifies absence of pain and the other means the worst pain imaginable. The researcher will apply the VAS scale to each patient at each visit to assess pain intensity. At the end of the clinical trial the change porcentage will be measured and compared between treatment groups. The patient will visit the clinic at days 0,3 and 7. The researcher will call the patient for follow up at days 1 and 5.

  7 dyas

• Number of participants with treatment-related adverse events through the patient's diary record.

  To describe the frequency, intensity and causality of the adverse events presented during the clinical trial by treatment group. The adverse events will be registered by the patient in the diary record. Each adverse event will be followed up at the discretion of the researcher.

  7 dyas

Secondary Outcomes (8)

• Analyze the average change in pain intensity according to VAS score at 1, 3, 5, and 7 days in each treatment group and in comparison with the baseline measurement.

  7 days

• Analyze the percentage change in pain intensity based on VAS score at 1, 3, 5, and 7 days in each treatment group and in comparison with the baseline measurement.

  7 days

• Comparison of the proportion of subjects with pain improvement (reduction in pain intensity) through VAS, ≥ 30% at 1, 3, 5, and 7 days in each treatment group and in comparison with the baseline measurement.

  7 days

• Comparison of the proportion of subjects with pain improvement (reduction in pain intensity) through VAS, ≥ 50% at 1, 3, 5, and 7 days in each treatment group and in comparison with the baseline measurement.

  7 days

• Assess and compare the degree of physical disability due to acute low back pain, measured through the Oswestry disability questionnaire at 1, 3, 5, and 7 days in each treatment group and in comparison with the baseline measurement.

  7 days

Other Outcomes (2)

• To report the percentage of therapeutic adherence at day 7 of the intervention in each treatment group.

  7 days

• Report the number of patients who require the use of rescue medication during the clinical trial in each treatment group

  7 days

Study Arms (2)

Etoricoxib+Cyanocobalamin

EXPERIMENTAL

Administered orally, 1 tablet a day for 7 days.

Drug: Etoricoxib + Cyanocobalamin fixed dose

Etoricoxib

ACTIVE COMPARATOR

Administered orally, 1 pill a day for 7 days.

Drug: Etoricoxib fixed dose

Interventions

Etoricoxib + Cyanocobalamin fixed dose DRUG

One tablet of 90 mg / 0.50 mg a day

Also known as: Etori + Cyano

Etoricoxib+Cyanocobalamin

Etoricoxib fixed dose DRUG

One pill of 90 mg a day

Also known as: Etori

Etoricoxib

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Agree to participate in the study and give written informed consent
• Patient with pain reported as moderate to severe intensity with ≥ 40 mm on the Visual Analog Scale (VAS).
• At least 4 points on the "Douleur Neuropathique-4 items" (DN-4) scale.
• Diagnosis of acute low back pain as a first-time episode or a previous episode 6 months before the enrollment day and lasting no more than 6 weeks.
• Women of childbearing potential under a medically acceptable method of contraception

You may not qualify if:

• Patients participating in another clinical trial involving an investigational treatment or participation in one within 4 weeks prior to study start
• Patients in whom the participation in the study may be influenced (employment relationship with the research site or sponsor, inmates, etc.)
• At medical discretion, a disease that affects prognosis and prevents outpatient management, for example, but not limited to: end-stage cancer, kidney, heart, respiratory or liver failure, mental illness or with scheduled surgical or hospital procedures
• History/presence of any disease or condition that, in the opinion of the Investigator, could pose a risk for the patient or confusing the efficacy and safety of the investigational product
• Patients in whom the study drug is contraindicated for medical reasons
• Patients with allergy or hypersensitivity to the active substance of the study drugs, related products or excipients (Etoricoxib of Cyanocobalamin)
• Pregnant women, women breastfeeding or planning a pregnancy during the conducting the study
• Significant history of gastrointestinal diseases (e.g., gastric ulcer, Crohn's disease, Ulcerative Colitis, etc.)
• Active opioid and/or NSAID treatment including COX-2 inhibitors, reported in the medical record within the last 72 hours of study entry.
• Patients with a history of congestive heart failure: NYHA II-IV.
• Concomitant use of strong CYP1A2 inhibitors (e.g., fluvoxamine, ciprofloxacin, etc.).
• Patients with a history of alcohol or drug abuse in the last year
• Patients with a history of ischemic heart disease, peripheral artery disease, and/or cerebral vascular disease (including patients who have recently undergone coronary revascularization or angioplasty)
• Patients with a history of seizures, epileptic status and/or grand mal seizures
• History of chronic liver failure Child-Pugh A, B, and/or C

Sponsors & Collaborators

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

Study Sites (1)

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

Mexico City, Mexico City, 11000, Mexico

Location

Related Publications (14)

• Martina SD, Vesta KS, Ripley TL. Etoricoxib: a highly selective COX-2 inhibitor. Ann Pharmacother. 2005 May;39(5):854-62. doi: 10.1345/aph.1E543. Epub 2005 Apr 12.

  PMID: 15827069 BACKGROUND

• Takemoto JK, Reynolds JK, Remsberg CM, Vega-Villa KR, Davies NM. Clinical pharmacokinetic and pharmacodynamic profile of etoricoxib. Clin Pharmacokinet. 2008;47(11):703-20. doi: 10.2165/00003088-200847110-00002.

  PMID: 18840026 BACKGROUND

• Chiu CK, Low TH, Tey YS, Singh VA, Shong HK. The efficacy and safety of intramuscular injections of methylcobalamin in patients with chronic nonspecific low back pain: a randomised controlled trial. Singapore Med J. 2011 Dec;52(12):868-73.

  PMID: 22159928 BACKGROUND

• Pallay RM, Seger W, Adler JL, Ettlinger RE, Quaidoo EA, Lipetz R, O'Brien K, Mucciola L, Skalky CS, Petruschke RA, Bohidar NR, Geba GP. Etoricoxib reduced pain and disability and improved quality of life in patients with chronic low back pain: a 3 month, randomized, controlled trial. Scand J Rheumatol. 2004;33(4):257-66. doi: 10.1080/03009740410005728.

  PMID: 15370723 BACKGROUND

• Letizia Mauro G, Lauricella L, Vecchio M, Tomasello S, Scaturro D. Efficacy and tolerability of a fixed dose combination of cortex phospholipid liposomes and cyanocobalamin for intramuscular use in peripheral neuropathies. Minerva Med. 2019 Oct;110(5):455-463. doi: 10.23736/S0026-4806.19.06068-3.

  PMID: 31368292 BACKGROUND

• Zhang YF, Ning G. Mecobalamin. Expert Opin Investig Drugs. 2008 Jun;17(6):953-64. doi: 10.1517/13543784.17.6.953.

  PMID: 18491996 BACKGROUND

• Peracchi M, Bamonti Catena F, Pomati M, De Franceschi M, Scalabrino G. Human cobalamin deficiency: alterations in serum tumour necrosis factor-alpha and epidermal growth factor. Eur J Haematol. 2001 Aug;67(2):123-7. doi: 10.1034/j.1600-0609.2001.t01-1-00507.x.

  PMID: 11722601 BACKGROUND

• Mauro GL, Martorana U, Cataldo P, Brancato G, Letizia G. Vitamin B12 in low back pain: a randomised, double-blind, placebo-controlled study. Eur Rev Med Pharmacol Sci. 2000 May-Jun;4(3):53-8.

  PMID: 11558625 BACKGROUND

• Calderon-Ospina CA, Nava-Mesa MO, Arbelaez Ariza CE. Effect of Combined Diclofenac and B Vitamins (Thiamine, Pyridoxine, and Cyanocobalamin) for Low Back Pain Management: Systematic Review and Meta-analysis. Pain Med. 2020 Apr 1;21(4):766-781. doi: 10.1093/pm/pnz216.

  PMID: 31529101 BACKGROUND

• Bacchi S, Palumbo P, Sponta A, Coppolino MF. Clinical pharmacology of non-steroidal anti-inflammatory drugs: a review. Antiinflamm Antiallergy Agents Med Chem. 2012;11(1):52-64. doi: 10.2174/187152312803476255.

  PMID: 22934743 BACKGROUND

• Antoniou K, Malamas M, Drosos AA. Clinical pharmacology of celecoxib, a COX-2 selective inhibitor. Expert Opin Pharmacother. 2007 Aug;8(11):1719-32. doi: 10.1517/14656566.8.11.1719.

  PMID: 17685888 BACKGROUND

• Smeets R, Koke A, Lin CW, Ferreira M, Demoulin C. Measures of function in low back pain/disorders: Low Back Pain Rating Scale (LBPRS), Oswestry Disability Index (ODI), Progressive Isoinertial Lifting Evaluation (PILE), Quebec Back Pain Disability Scale (QBPDS), and Roland-Morris Disability Questionnaire (RDQ). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S158-73. doi: 10.1002/acr.20542. No abstract available.

  PMID: 22588742 BACKGROUND

• Shukla AK, Jhaj R, Misra S, Ahmed SN, Nanda M, Chaudhary D. Agreement between WHO-UMC causality scale and the Naranjo algorithm for causality assessment of adverse drug reactions. J Family Med Prim Care. 2021 Sep;10(9):3303-3308. doi: 10.4103/jfmpc.jfmpc_831_21. Epub 2021 Sep 30.

  PMID: 34760748 BACKGROUND

• Mibielli MA, Geller M, Cohen JC, Goldberg SG, Cohen MT, Nunes CP, Oliveira LB, da Fonseca AS. Diclofenac plus B vitamins versus diclofenac monotherapy in lumbago: the DOLOR study. Curr Med Res Opin. 2009 Nov;25(11):2589-99. doi: 10.3111/13696990903246911.

  PMID: 19731994 BACKGROUND

MeSH Terms

Conditions

Acute Pain

Interventions

Etoricoxib; Vitamin B 12

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; Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Ricardo Choza-Romero, MD

  Centro de Atención e Investigación Clínica S.C.

  PRINCIPAL INVESTIGATOR

• Adelfia Urenda-Quezada, MD

  Servicios Avanzados de Investigación Médica Mediadvance S.C.

  PRINCIPAL INVESTIGATOR

• Isabel E Rucker Joerg, MD

  Clinical Research Institute S.C.

  PRINCIPAL INVESTIGATOR

• Jesus H Mendoza-Ramírez, MD

  Unidad Clínica de Bioequivalencia, S. de R.L. de C.V.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: July 24, 2024
• Study Start: April 26, 2024
• Primary Completion: October 4, 2024
• Study Completion: October 11, 2024
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)