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Acute Low-back PainPhase 3NCT06517823

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

A Phase 3 study testing Etoricoxib + Cyanocobalamin fixed dose and Etoricoxib fixed dose in people with Acute Low-back Pain, run by Laboratorios Silanes S.A. de C.V. at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Acute Low-back Pain
What is being tested?
Etoricoxib + Cyanocobalamin fixed dose and Etoricoxib fixed dose
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
190 participants
Where
1 siteMexico
Study dates
26 Apr 2024to 11 Oct 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 19Show fewer
  • 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
  • History of acute renal failure (glomerular filtration rate <30 ml/min/1.72 m2)
  • Patient with a history of chronic pain associated with fibromyalgia, Paget's disease or bone pain induced by metastatic cancer
  • Low back pain due to a history of major trauma in the past 12 months (e.g., vertebral fracture, post-traumatic spondylolisthesis) or due to a visceral disorder (e.g., dysmenorrhea, history of endometriosis).
  • Patients with symptoms suggestive of COVID-19 infection (fever, cough, dyspnea) and/or contact in the last 14 days with a suspected or positive patient for COVID-19

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Laboratorio Silanes, S.A. de C.V.

    Mexico City, Mexico City, 11000

Other trials in Mexico

About this study

Official title: Efficacy and Safety of the Fixed-Dose Combination of Etoricoxib/Cyanocobalamin Versus Etoricoxib in the Treatment of Patients with Acute Low Back Pain

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

Read the detailed description

Researchers will compare the fixed-dose combination of Etoricoxib/Cyanocobalamin versus Etoricoxib in acute low back pain by comparing the proportion of patients that reported an improvement in pain during the 7 days of follow up. The adverse events related to the interventions will be registered during follow up.

Participants will:

  • Be randomized into one of the 2 intervention groups (A or B)
  • Visit the clinic in 3 occasions (day 0, day 3 of follow up and day 7 of follow up)
  • In case needed the patient could take 50 mg of tramadol, as a rescue medication, previous authorization of de principal investigator
Being tested
Etoricoxib + Cyanocobalamin fixed dose, Etoricoxib fixed dose
Keywords
Acute Low -back Pain, Acute pain, Etoricoxib, Cyanocobalamin
Medical subject headings
Acute Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Etoricoxib + Cyanocobalamin fixed doseDrug

    Also called Etori + Cyano

    One tablet of 90 mg / 0.50 mg a day

  • Etoricoxib fixed doseDrug

    Also called Etori

    One pill of 90 mg a day

Study groups in NCT06517823
Study groupRoleWhat they receive
Etoricoxib+CyanocobalaminExperimentalAdministered orally, 1 tablet a day for 7 days.
Receives: Drug: Etoricoxib + Cyanocobalamin fixed dose
EtoricoxibActive comparatorAdministered orally, 1 pill a day for 7 days.
Receives: Drug: Etoricoxib fixed dose

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 7 dyas

  2. 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.

    Measured: 7 dyas

Secondary outcomes (8)

  1. 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.

    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.

    Measured: 7 days

  2. 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.

    % change= ((Final Measurement-Initial Measurement)/(Initial Measurement))*100

    Measured: 7 days

  3. 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.

    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. The proportion of patiens with an improvement of pain >30% will be reported and compared between treatment groups at days 1,3,5 and 7.

    Measured: 7 days

  4. 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.

    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. The proportion of patiens with an improvement of pain >30% will be reported and compared between treatment groups at days 1,3,5 and 7.

    Measured: 7 days

  5. 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.

    The Oswestry questionnaire has been designed to give us information as to how the back pain has affected the ability to manage everyday life of patients, it classifies QOL as: no disability, mild disability, moderate disability, severe disability and completely disabled. The disability degree would be compared.

    Measured: 7 days

  6. Assess and compare the degree of disability to perform daily activities due to low back pain, reported through Roland-Morris questionnaire at 1, 3, 5, and 7 days in each treatment group and in comparison with the baseline measurement.

    The Roland-Morris questionnaire has been designed to assess the activities of daily living functional mobility pain. A maximum score of 24 indicates the greatest degree of disability from pain. The disability degree will be compared.

    Measured: 7 days

  7. Assess changes in the score on the "Douleur Neuropathique-4 items" scale (DN-4) at days 3 and 7 in each treatment group and in comparison with the baseline measurement.

    The DN4 is a clinician-administered, neuropathic pain diagnostic questionnaire, consisting of ten items grouped in four sections. The first seven items are related to the quality of pain (burning, painful cold, electric shocks) and its association to abnormal sensations (tingling, pins and needles, numbness, itching). The other three items are related to neurological examination in the painful area (touch hypoesthesia, pinprick hypoesthesia, tactile allodynia).

    Measured: 7 days

  8. Report the number of patients who present therapeutic failure during the study among the treatment groups

    Therapeutic failure will be defined by the principal researcher previous medical consult, the following criteria must be present:

    • When there is a decrease <10 mm or increase in VAS values compared to baseline and a ≥ 80% adherence to treatment

    Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2024
  2. Study start26 Apr 2024
  3. Primary completion4 Oct 2024
  4. Study completion11 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
190 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06517823
Sponsor's protocol ID
SIL-30952-III-23(1)
Status last verified
Nov 2024
First submitted
18 Jul 2024
Last updated
27 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 15827069

  • 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.

    PubMed 18840026

  • 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.

    PubMed 22159928

  • 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.

    PubMed 15370723

  • 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.

    PubMed 31368292

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

    PubMed 18491996

  • 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.

    PubMed 11722601

  • 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.

    PubMed 11558625

  • 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.

    PubMed 31529101

  • 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.

    PubMed 22934743

  • 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.

    PubMed 17685888

  • 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.

    PubMed 22588742

  • 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.

    PubMed 34760748

  • 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.

    PubMed 19731994

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Etoricoxib + Cyanocobalamin fixed dose and Etoricoxib fixed dose in people with Acute Low-back Pain, run by Laboratorios Silanes S.A. de C.V. at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: 7 dyas). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06517823, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.

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