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

NCT05001555 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2024-11-13

No results posted yet for this study

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.

Conditions

  • Acute Low Back Pain

Interventions

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.

Sponsors & Collaborators

  • Laboratorios Silanes S.A. de C.V.

    lead INDUSTRY

Principal Investigators

  • Pamela Delgado García, M.D · IMACEN S.A. de C.V.,

  • Adelfia Urenda Quezada, M.D · Mediadvance Clinical S.A.P.I. de C.V.

  • Ma. Dolores Alonso Martínez, M.D · CICMEX Centro de Investigación Clínica de México

  • Juan B Alcocer Herrera, M.D · INBIOMEDyC Querétaro

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-23
Primary Completion
2023-04-24
Completion
2023-04-25

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05001555 on ClinicalTrials.gov