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Post-nasal Drainage as an Extraesophageal Manifestation of Reflux

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ClinicalTrials.gov Identifier: NCT00199953
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : January 30, 2017
Sponsor:
Collaborators:
Ortho-McNeil, Inc.
Eisai Inc.
Information provided by:
Medical College of Wisconsin

Brief Summary:

Objectives of this study are:

  • To quantitatively evaluate the relationship between extraesophageal manifestations of gastroesophageal reflux (EER) and postnasal drainage(PND)in a group of patients without radiographic or endoscopic evidence of sinonasal inflammatory disease.
  • To assess the efficacy of BID proton pump inhibitors (PPI) in the management of patients with symptomatic postnasal drainage.

Condition or disease Intervention/treatment Phase
Postnasal Drainage Drug: Rabeprazole 20 mg twice a day for 90-day period treatment Phase 2

Detailed Description:

Gastroesophageal reflux disease(GERD) is a common disorder of the esophagus, affecting 7-10% of the U.S. population. Characteristic symptoms include heartburn, chest pain, and indigestion. EER denotes gastroesophageal refluxate that reaches structures above the upper esophageal sphincter. EER has been implicated in the pathogenesis of several otolaryngologic disorders such as chronic posterior laryngitis, laryngeal contact ulcer or granuloma, paroxysmal laryngospasm, vocal cord nodules, Reinke's edema, subglottic or laryngotracheal stenosis, globus pharyngeus,and laryngeal and hypopharyngeal carcinoma. In addition, EER has been associated with disorders of both the lower and upper respiratory tract and with chronic sinonasal inflammation.

Patients with EER rarely complain of the common symptoms of GERD, such as heartburn. Often they present with symptoms involving the larynx and pharynx, including throat-clearing, globus pharyngeus, and postnasal drainage. These symptoms may be present due to direct irritation of the nasal epithelium by gastric refluxate and/or a neurogenic inflammatory process mediated by the autonomic nervous system.

Specific Aims:

  • Specific Aim 1: To establish the relation ship between EER and PND in patients without sinonasal inflammatory disease.
  • Hypothesis 1: In patients without radiographic or endoscopic evidence of sinonasal inflammatory disease, PND is a symptom of EER.
  • Method 1: We will test this hypothesis utilizing a 2-site 24-hour pH probe test in a symptomatic patient group and compare then to a previously tested age and sex-matched control group.
  • Specific Aim 2: To establish the efficacy of PPI in the management of PND.
  • Hypothesis 2: Patients with a chief complaint of PND and no sinonasal inflammatory disease will improve with 3-month PPI treatment with Rabeprazole 20 mg twice a day.
  • Method 2: A group of patients with a chief complaint of postnasal drainage, without radiographic or endoscopic evidence of sinonasal inflammatory disease will be entered into a prospective placebo-controlled trial utilizing BID PPIs over a 3-month period. the primary outcome measures will be: 1) Visual analog Scales, assessing the severity and frequency of PND at days 0 and 90 of treatment and 2)A quantitative color analysis of laryngeal erythema, utilizing videolaryngoscopy at days 0 and 90 of treatment.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Diagnostic
Official Title: Post-nasal Drainage as an Extraesophageal Manifestation of Reflux
Study Start Date : June 2002
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
Drug Information available for: Rabeprazole




Primary Outcome Measures :
  1. - VAS1:Visual Analog Scale indicating severity of PND
  2. - VAS2:Visual Analog Scale indicating frequency of PND
  3. - VAS3:Visual Analog Scale indicating frequency of throat-clearing.

Secondary Outcome Measures :
  1. - Two-site 24-hour pH probe test indicating presence or gastroesophageal reflux episodes.
  2. - Videolaryngoscopy for quantitative color analysis evaluation of laryngeal erythema as index of EER.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >18 and <70;
  • PND as chief complaint;
  • No known acute or chronic sinus disease;
  • Nonsmokers;
  • Subjects with no history of esophageal or gastric surgery
  • Subjects with no history of allergic disease
  • Women non pregnant.

Exclusion Criteria:

  • Age , 18 or > 70;
  • No PND as chief complaint
  • Al;ergic disease or acute or chronic sinus disease;
  • Smokers;
  • Pregnant women;
  • Subjects with history of esophageal or gastric surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00199953


Locations
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United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
Ortho-McNeil, Inc.
Eisai Inc.
Investigators
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Principal Investigator: Todd A Loehrl, MD Medical College of Wisconsin
Publications:

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ClinicalTrials.gov Identifier: NCT00199953    
Other Study ID Numbers: RAB-USA-57
IRB numbers:
FMLH # 02-033
HRRC # 056-02
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: January 30, 2017
Last Verified: November 2013
Keywords provided by Medical College of Wisconsin:
Postnasal drainage
Extraesophageal reflux
Additional relevant MeSH terms:
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Rabeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action