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Trial record 29 of 536 for:    Taste Disorders AND taste

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

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ClinicalTrials.gov Identifier: NCT03086070
Recruitment Status : Completed
First Posted : March 22, 2017
Last Update Posted : July 21, 2017
Sponsor:
Collaborators:
University Hospital Center Sisters of Charity, Zagreb, Croatia
Belupo
Information provided by (Responsible Party):
Davor Plavec, Children's Hospital Srebrnjak

Tracking Information
First Submitted Date  ICMJE March 6, 2017
First Posted Date  ICMJE March 22, 2017
Last Update Posted Date July 21, 2017
Actual Study Start Date  ICMJE January 1, 2010
Actual Primary Completion Date April 30, 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2017)
  • Reduction in signs and symptoms of laryngopharyngeal reflux [ Time Frame: 8 weeks ]
    Reflux symptom index (RSI) score
  • Reduction in signs and symptoms of laryngopharyngeal reflux [ Time Frame: 8 weeks ]
    Reflux finding score (RFS)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03086070 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2017)
  • Reduction of signs and symptoms of comorbid chronic rhinosinusitis [ Time Frame: 8 weeks ]
    Nasal obstruction, anterior/posterior nasal drip, headache, sneezing, cough, smell and taste disorder with frequency and intensity of the symptoms was graded from 0 (no problem) to 3 (severe problem). Nasal endoscopy with endoscopy scores were based on the assessment of nasal mucosa edema, secretions and presence of polyps and were graded from 0 (no problem) to 3 (severe problem).
  • Association of the severity of signs and symptoms of laryngopharyngeal reflux with the ones of chronic rhinosinusitis [ Time Frame: Baseline and after 8 weeks of treatment. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Omeprazole 20 mg in Patients With Laryngopharyngeal reflux and Comorbid Chronic Rhinosinusitis
Official Title  ICMJE Omeprazole 20 mg in Patients With Laryngopharyngeal reflux and Comorbid Chronic Rhinosinusitis - a Randomized, Double Blind, Placebo Controlled Trial
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
randomized, double blind, placebo controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Laryngopharyngeal Reflux
  • Chronic Rhinosinusitis (Diagnosis)
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Treatment arm
    omeprazole 20 mg capsule once daily for 8 weeks
    Intervention: Drug: Omeprazole 20mg
  • Placebo Comparator: Placebo arm
    matching placebo capsules ones daily for 8 weeks
    Intervention: Drug: Placebo oral capsule
Publications * Anzić SA, Turkalj M, Župan A, Labor M, Plavec D, Baudoin T. Eight weeks of omeprazole 20 mg significantly reduces both laryngopharyngeal reflux and comorbid chronic rhinosinusitis signs and symptoms: Randomised, double-blind, placebo-controlled trial. Clin Otolaryngol. 2018 Apr;43(2):496-501. doi: 10.1111/coa.13005. Epub 2017 Oct 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 15, 2017)
60
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 30, 2010
Actual Primary Completion Date April 30, 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • laryngopharyngeal reflux
  • chronic rhinosinusitis

Exclusion Criteria:

  • allergic rhinitis
  • asthma
  • cystic fibrosis
  • nasal polyposis
  • severe systemic diseases
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03086070
Other Study ID Numbers  ICMJE CHS-ENT01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Anonymised individual participant data can be obtained for other researchers on a written request to the principal investigator.
Responsible Party Davor Plavec, Children's Hospital Srebrnjak
Study Sponsor  ICMJE Children's Hospital Srebrnjak
Collaborators  ICMJE
  • University Hospital Center Sisters of Charity, Zagreb, Croatia
  • Belupo
Investigators  ICMJE
Principal Investigator: Srđan A Anzić, MD, PhD Children's Hospital Srebrnjak
PRS Account Children's Hospital Srebrnjak
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP