At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 124 enrolled
Drug / intervention
Etoricoxib 90 mg / Tramadol 50 mg +1 moredrug
Likely dose
Etoricoxib 90 mg / Tramadol 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Confirmatory Efficacy and Safety Study of the Fixed-dose Combination of Etoricoxib / Tramadol Versus Acetaminophen / Tramadol for the Management of Acute Low Back Pain.
In Brief
A Phase 3 clinical trial evaluating Etoricoxib 90 mg / Tramadol 50 mg and Acetaminophen 325 mg / Tramadol 37.5 mg for Acute Low Back Pain. Completed, enrolled 124 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Low Back Pain
CountriesMexico
Collaborators--
Timeline
Phase 3CompletedFinished
20222023202420252026
First PostedJul 2021
Enrollment StartNov 2021
Primary CompletionMar 2022
Study CompletionApr 2022
TodayJul 2026
First PostedJul 20, 2021
Enrollment StartNov 29, 2021
Primary CompletionMar 15, 2022
Study CompletionApr 10, 2022
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 5.0 years ago
Interventions
Etoricoxib 90 mg / Tramadol 50 mgdrug
One packet diluted in 100 ml of water, every 24 hours of 90 mg/50 mg.
Acetaminophen 325 mg / Tramadol 37.5 mgdrug
One tablet, every 8 hours of 325 mg/ 37.5 m