deltatrials
Completed OBSERVATIONAL NCT01389401

Salivary Epidermal Growth Factor (EGF) Concentration Before and After Treatment of Reflux Laryngitis

Salivary Epidermal Growth Factor (EGF) Concentration Before and After Treatment of Reflux Laryngitis: Final Results

Sponsor: Faculdade de Ciências Médicas da Santa Casa de São Paulo

Interventions omeprazole
Updated 11 times since 2017 Last updated: Mar 5, 2013 Started: Jan 31, 2009 Primary completion: Jan 31, 2011 Completion: Jul 31, 2011
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01389401, this observational or N/A phase trial focuses on Chronic Laryngitis and Gastroesophageal Reflux Disease (GERD) and remains completed. Sponsored by Faculdade de Ciências Médicas da Santa Casa de São Paulo, it has been updated 11 times since 2009, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Study Description(click to expand)

Background \& Aims: Gastroesophageal Reflux Disease (GERD) is known to affect the upper airways and may cause a variety of inflammatory changes in the pharynx and larynx. The pathophysiology of the supraesophageal forms of GERD is widely unknown. Studies have suggested decreased salivary epidermal growth factor (EGF) concentrations in patients with reflux esophagitis and laryngitis. It is however unclear if these abnormalities are primary or secondary. The aim of the current cohort study was to compare salivary EGF concentrations in adults with reflux laryngitis before and after treatment and control of the disease to that of healthy individuals. Methods: Twenty-one patients with reflux laryngitis were studied prospectively at a tertiary teaching hospital. Spontaneous whole saliva was sampled before and after a 16-week course of full dose proton pump inhibitor (PPI) twice daily and compared to that of 13 healthy controls. Salivary EGF concentrations were established using a commercially available Elisa kit.

Background \& Aims: Gastroesophageal Reflux Disease (GERD) is known to affect the upper airways and may cause a variety of inflammatory changes in the pharynx and larynx. The pathophysiology of the supraesophageal forms of GERD is widely unknown. Studies have suggested decreased salivary epidermal growth factor (EGF) concentrations in patients with reflux esophagitis and laryngitis. It is however unclear if these abnormalities are primary or secondary. The aim of the current cohort study was to compare salivary EGF concentrations in adults with reflux laryngitis before and after treatment and control of the disease to that of healthy individuals. Methods: Twenty-one patients with reflux laryngitis were studied prospectively at a tertiary teaching hospital. Spontaneous whole saliva was sampled before and after a 16-week course of full dose proton pump inhibitor (PPI) twice daily and compared to that of 13 healthy controls. Salivary EGF concentrations were established using a commercially available Elisa kit.

Status Flow

~Jan 2017 – ~Aug 2017 · 7 months · monthly snapshotCompleted~Aug 2017 – ~Apr 2018 · 8 months · monthly snapshotCompleted~Apr 2018 – ~May 2018 · 30 days · monthly snapshotCompleted~May 2018 – ~Jun 2018 · 31 days · monthly snapshotCompleted~Jun 2018 – ~Nov 2020 · 29 months · monthly snapshotCompleted~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshotCompleted~Jan 2021 – ~Dec 2021 · 11 months · monthly snapshotCompleted~Dec 2021 – ~Jul 2024 · 31 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

11 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed

  2. Sep 2024 — Present [monthly]

    Completed

  3. Jul 2024 — Sep 2024 [monthly]

    Completed

  4. Dec 2021 — Jul 2024 [monthly]

    Completed

  5. Jan 2021 — Dec 2021 [monthly]

    Completed

Show 6 earlier versions
  1. Nov 2020 — Jan 2021 [monthly]

    Completed

  2. Jun 2018 — Nov 2020 [monthly]

    Completed

  3. May 2018 — Jun 2018 [monthly]

    Completed

  4. Apr 2018 — May 2018 [monthly]

    Completed

    Phase: NANone

  5. Aug 2017 — Apr 2018 [monthly]

    Completed NA

  6. Jan 2017 — Aug 2017 [monthly]

    Completed NA

    First recorded

Jan 2009

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Faculdade de Ciências Médicas da Santa Casa de São Paulo
Data source: Faculdade de Ciências Médicas da Santa Casa de São Paulo

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations