Efficacy and Safety of Fixed-dose Combination of Etoricoxib/Tramadol vs Acetaminophen/Tramadol for Acute Low Back Pain
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|ClinicalTrials.gov Identifier: NCT04968158|
Recruitment Status : Completed
First Posted : July 20, 2021
Last Update Posted : April 13, 2022
|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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||124 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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
- 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.
- 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.
- 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.
- Adverse events [ Time Frame: 7 days. ]Compare the frequency of adverse events presented during the study between the treatment groups.
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
|Laboratorio Silanes, S.A. de C.V.|
|Mexico City, Mexico, 11000|
|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.|