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Omeprazole 20 mg in Patients With Laryngopharyngeal reflux and Comorbid Chronic Rhinosinusitis

NCT03086070 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-12-30

No results posted yet for this study

Summary

The hypothesis of this study is that a gastroesophageal reflux recommended treatment with proton pump inhibitor (dose and duration) compared to placebo significantly reduces both the signs and symptoms of laryngopharyngeal reflux and comorbid chronic rhinosinusitis. Primary objective was to determine whether 8 weeks of treatment with omeprazole 20 mg ones daily (OD) significantly reduces the signs and symptoms of laryngopharyngeal reflux when compared to placebo in patients with laryngopharyngeal reflux with comorbid chronic rhinosinusitis. Secondary objectives were to determine whether 8 weeks of treatment with omeprazole 20 mg OD significantly reduces the signs and symptoms of comorbid chronic rhinosinusitis in patients with laryngopharyngeal reflux when compared to matching placebo; and to investigate the association of the severity of signs and symptoms of laryngopharyngeal reflux with the ones of chronic rhinosinusitis in the same group of patients. The research was carried out as a double blind randomized placebo controlled trial. Patients were randomized into two groups in an approximate 1:1 ratio using a concealed random sequence. After randomization and initial assessment treatment was initialized. Patients on active treatment were given omeprazole 20 mg once daily half an hour before breakfast for 8 weeks, while those in the placebo group were given matching placebo tablets using the same regimen for 8 weeks as the group on the active treatment. Patients were reassessed at the end of treatment for signs and symptoms of laryngopharyngeal reflux and comorbid chronic rhinosinusitis.

Conditions

  • Laryngopharyngeal Reflux
  • Chronic Rhinosinusitis (Diagnosis)

Interventions

DRUG

Omeprazole 20mg

omeprazole 20 mg capsules were administered per os half an hour before breakfast for 8 weeks

DRUG

Placebo oral capsule

Matching placebo oral capsules were administered per os half an hour before breakfast for 8 weeks

Sponsors & Collaborators

  • University Hospital Center Sisters of Charity, Zagreb, Croatia

    collaborator UNKNOWN

  • Belupo

    collaborator OTHER

  • Children's Hospital Srebrnjak

    lead OTHER

Principal Investigators

  • Srđan A Anzić, MD, PhD · Children's Hospital Srebrnjak

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-01
Primary Completion
2010-04-30
Completion
2010-06-30

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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 NCT03086070 on ClinicalTrials.gov