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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04968158
Recruitment Status : Completed
First Posted : July 20, 2021
Last Update Posted : April 13, 2022
Sponsor:
Information provided by (Responsible Party):
Laboratorios Silanes S.A. de C.V.

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.

Condition or disease Intervention/treatment Phase
Acute Low Back Pain Drug: Etoricoxib 90 mg / Tramadol 50 mg Drug: Acetaminophen 325 mg / Tramadol 37.5 mg Phase 3

Detailed Description:
Patients with back pain from the level of the lowest rib to the gluteal crease, with or without radiation to the legs, as a first-time episode or after another at least 6 months before and lasting no more than 6 weeks, that in the opinion of the doctor requires treatment with the combination of an anti-inflammatory and an analgesic. Study to evaluate the efficacy and safety of the fixed-dose combination of etoricoxib 90 mg and tramadol 50 mg compared with the fixed-dose therapy of acetaminophen 325 mg and tramadol 37.5 mg for the management of acute low back pain. Evaluate and compare the average change in pain reported through the VAS at 3, 5 and 7 days with respect to its baseline measurement by treatment group. An exploratory analysis of the data will be carried out to identify aberrant, outliers, or missing values. To present the numerical variables, the measures of central tendency and dispersion appropriate to the distribution of the data will be used and the categorical variables will be expressed as frequency and percentage.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Confirmatory Efficacy and Safety Study of the Fixed-dose Combination of Etoricoxib / Tramadol Versus Acetaminophen / Tramadol for the Management of Acute Low Back Pain.
Actual Study Start Date : November 29, 2021
Actual Primary Completion Date : March 15, 2022
Actual Study Completion Date : April 10, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: Group A: Etoricoxib/Tramadol
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
One packet diluted in 100 ml of water, every 24 hours of 90 mg/50 mg.
Other Name: E/T

Active Comparator: Group B: Acetaminophen / Tramadol
Administered orally, one tablet, every 8 hours, for 7 days.
Drug: Acetaminophen 325 mg / Tramadol 37.5 mg
One tablet, every 8 hours of 325 mg/ 37.5 m
Other Name: A/T




Primary Outcome Measures :
  1. Average change in reported pain [ Time Frame: Baseline, 3, 5 and 7 days. ]
    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


Secondary Outcome Measures :
  1. Proportion of patients with a 30% reduction in pain intensity [ Time Frame: Baseline and 7 days. ]
    Describe the proportion of patients who reported a 30% reduction in pain intensity measure by 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.

  2. Degree of disability due to low back pain [ Time Frame: Baseline and 7 days. ]
    Evaluate the degree of disability due to low back pain measured through the Oswestry disability scale per treatment group. It measures the limitations in daily activities in the presence of pain in the lumbar region, consists of 10 questions with 6 possible answers considering the intensity of the pain, basic activities of daily life such as: personal care, sexual activity, sleep, travel and social life.

  3. Degree of inability to perform daily activities [ Time Frame: Baseline and 7 days. ]
    Assess the degree of inability to perform daily activities through the Roland-Morris scale per group. It´s a self-applied scale where the extreme values range between 0 (absence of disability) and 24 (maximum disability) and is categorized according to the relevance of the score obtained where the optimal threshold of variation is 3 and 4 points.

  4. Adverse events [ Time Frame: 7 days. ]
    Compare the frequency of adverse events presented during the study between the treatment groups.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.
  • Oncological patients (except basal cell skin cancer) or with serious diseases that, in the opinion of the investigator, have a serious prognosis or a life expectancy of less than 1 year, as well as mental illnesses.
  • The patient is participating in another clinical study involving an investigational treatment or participated in one in the previous 4 weeks.
  • Patients whose participation in the study may be influenced (employment relationship with the research center or sponsor, inmates, etc.).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04968158


Locations
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Mexico
Laboratorio Silanes, S.A. de C.V.
Mexico City, Mexico, 11000
Sponsors and Collaborators
Laboratorios Silanes S.A. de C.V.
Investigators
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Principal Investigator: 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.
Additional Information:
Publications:

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Responsible Party: Laboratorios Silanes S.A. de C.V.
ClinicalTrials.gov Identifier: NCT04968158    
Other Study ID Numbers: SIL-30138-III-21(1)
First Posted: July 20, 2021    Key Record Dates
Last Update Posted: April 13, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Laboratorios Silanes S.A. de C.V.:
Back pain
Etoricoxib
Tramadol
Fixed dose
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Acetaminophen
Etoricoxib
Tramadol
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action