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Confirmatory Study on the Efficacy and Safety of the Fixed-dose Combination of Desloratadine/Betamethasone Versus Desloratadine

NCT06916884 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-04-08

No results posted yet for this study

Summary

Phase IIIb , longitudinal, multicenter, randomized, double-blind, to evaluate efficacy and safety of the fixed-dose combination of Desloratadine 5 mg / Betamethasone 0.25 mg versus Desloratadine 5 mg monotherapy as treatment for symptoms associated with allergic rhinitis.

Conditions

  • Allergic Rhinitis

Interventions

DRUG

Desloratadine / Betamethasone in fixed dose

1 tablet, once a day of 5 mg / 0.25 mg

DRUG

Desloratadine

1 tablet, once a day of 5 mg

Sponsors & Collaborators

  • Laboratorios Silanes S.A. de C.V.

    lead INDUSTRY

Principal Investigators

  • Francisco Murguía Martín, MD · Unidad de Medicina Especializada SMA

  • Tobías Avendaño Santiago, MD · Oaxaca Site Management Organization, S.C

  • Erika N Durón López, MD · Centro de Investigación Médica de Aguascalientes

  • María D Escobar Zalapa, MD · CICMEX Centro de Investigación Clínica de México S de RL de CV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-11
Primary Completion
2025-05-11
Completion
2025-06-11

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 NCT06916884 on ClinicalTrials.gov