NCT05001555

Efficacy and Safety of Dexketoprofen/Vitamin B Vs Dexketoprofen for Post-traumatic Cervical Sprain Grade I-II

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 174 (actual)
• Sponsor: Laboratorios Silanes S.A. de C.V. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

Study to evaluate the efficacy and safety of the Dexketoprofen / Vitamin B combination versus dexketoprofen for the management of acute pain secondary to post-traumatic cervical sprain grade I-II of the Quebec scale, evaluated by means of the Visual Analogue Scale (VAS). To compare the degree of disability due to neck pain measured through the Northwick Park Neck Pain Questionnaire in Spanish version on days 3, 5, and 7 compare to its baseline measurement between the treatment groups. Compare the proportion of subjects requiring rescue medication during the study between treatment groups. Describe the frequency and intensity of adverse events presented during the study.

Conditions

• Acute Low Back Pain

Interventions

Type	Name	Description
DRUG	Dexketoprofen/Vitamin B	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.
DRUG	Dexketoprofen	1 tablet of dexketoprofen 25 mg, orally, every 8 hours, for 7 days.

Timeline

• Start date: 2021-11-23
• Primary completion: 2023-04-24
• Completion: 2023-04-25
• First posted: 2021-08-12
• Last updated: 2024-11-13

Locations

1 site across 1 country: Mexico