At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 174 enrolled
Drug / intervention
Dexketoprofen/Vitamin B +1 moredrug
Likely dose
Dexketoprofen/Vitamin B 25 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.
Efficacy and Safety of the Combination Dexketoprofen / Vitamin B Vs Dexketoprofen in the Treatment of Pain in Patients with Post-traumatic Cervical Sprain Grade I-II of the Quebec Scale.
In Brief
A Phase 3 clinical trial evaluating Dexketoprofen/Vitamin B and Dexketoprofen for Acute Low Back Pain. Completed, enrolled 174 participants across 1 site.
Detailed Summary
Phase IIIb, multicenter, prospective, randomized, double-blind study to evaluate the fixed combination of Desketoprofen / Vitamin B in the management of acute pain in patients with cervical sprain grade I-II of the Quebec scale.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Low Back Pain
CountriesMexico
Collaborators--
Timeline
Phase 3CompletedFinished
20222023202420252026
First PostedAug 2021
Enrollment StartNov 2021
Primary CompletionApr 2023
Study CompletionApr 2023
TodayJul 2026
First PostedAug 12, 2021
Enrollment StartNov 23, 2021
Primary CompletionApr 24, 2023
Study CompletionApr 25, 2023
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 4.9 years ago
Interventions
Dexketoprofen/Vitamin Bdrug
1 capsule containing 25 mg of dexketoprofen / vitamin B (thiamine mononitrate 100 mg, Pyridoxine hydrochloride 50 mg, Cyanocobalamin 0.50 mg), orally, every 8 hours, for 7 days.
Dexketoprofendrug
1 tablet of dexketoprofen 25 mg, orally, every 8 hours, for 7 days.