Post-nasal Drainage as an Extraesophageal Manifestation of Reflux

NCT00199953 | Completed Phase 2

• 4 other identifiers: RAB-USA-57IRB numbers:FMLH # 02-033HRRC # 056-02
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Postnasal Drainage

Keywords

Postnasal drainage; Extraesophageal reflux

Outcome Measures

Primary Outcomes (3)

• - VAS1:Visual Analog Scale indicating severity of PND

• - VAS2:Visual Analog Scale indicating frequency of PND

• - VAS3:Visual Analog Scale indicating frequency of throat-clearing.

Secondary Outcomes (2)

• - Two-site 24-hour pH probe test indicating presence or gastroesophageal reflux episodes.

• - Videolaryngoscopy for quantitative color analysis evaluation of laryngeal erythema as index of EER.

Interventions

Rabeprazole 20 mg twice a day for 90-day period treatment DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• Ortho-McNeil, Inc.: collaborator
• Eisai Inc.: collaborator

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (9)

• Ulualp SO, Toohill RJ. Laryngopharyngeal reflux: state of the art diagnosis and treatment. Otolaryngol Clin North Am. 2000 Aug;33(4):785-802. doi: 10.1016/s0030-6665(05)70244-9.

  PMID: 10918661 BACKGROUND

• Lodi U, Harding SM, Coghlan HC, Guzzo MR, Walker LH. Autonomic regulation in asthmatics with gastroesophageal reflux. Chest. 1997 Jan;111(1):65-70. doi: 10.1378/chest.111.1.65.

  PMID: 8995994 BACKGROUND

• Chambers DW, Davis WE, Cook PR, Nishioka GJ, Rudman DT. Long-term outcome analysis of functional endoscopic sinus surgery: correlation of symptoms with endoscopic examination findings and potential prognostic variables. Laryngoscope. 1997 Apr;107(4):504-10. doi: 10.1097/00005537-199704000-00014.

  PMID: 9111381 BACKGROUND

• Ulualp SO, Toohill RJ, Hoffmann R, Shaker R. Possible relationship of gastroesophagopharyngeal acid reflux with pathogenesis of chronic sinusitis. Am J Rhinol. 1999 May-Jun;13(3):197-202. doi: 10.2500/105065899781389777.

  PMID: 10392238 BACKGROUND

• Jaradeh SS, Smith TL, Torrico L, Prieto TE, Loehrl TA, Darling RJ, Toohill RJ. Autonomic nervous system evaluation of patients with vasomotor rhinitis. Laryngoscope. 2000 Nov;110(11):1828-31. doi: 10.1097/00005537-200011000-00012.

  PMID: 11081594 BACKGROUND

• Smit CF, Tan J, Devriese PP, Mathus-Vliegen LM, Brandsen M, Schouwenburg PF. Ambulatory pH measurements at the upper esophageal sphincter. Laryngoscope. 1998 Feb;108(2):299-302. doi: 10.1097/00005537-199802000-00027. No abstract available.

  PMID: 9473087 BACKGROUND

• Hanson DG, Jiang J, Chi W. Quantitative color analysis of laryngeal erythema in chronic posterior laryngitis. J Voice. 1998 Mar;12(1):78-83. doi: 10.1016/s0892-1997(98)80077-5.

  PMID: 9619981 BACKGROUND

• El-Serag HB, Lee P, Buchner A, Inadomi JM, Gavin M, McCarthy DM. Lansoprazole treatment of patients with chronic idiopathic laryngitis: a placebo-controlled trial. Am J Gastroenterol. 2001 Apr;96(4):979-83. doi: 10.1111/j.1572-0241.2001.03681.x.

  PMID: 11316215 BACKGROUND

• Smith TL, Correa AJ, Kuo T, Reinisch L. Radiofrequency tissue ablation of the inferior turbinates using a thermocouple feedback electrode. Laryngoscope. 1999 Nov;109(11):1760-5. doi: 10.1097/00005537-199911000-00007.

  PMID: 10569403 BACKGROUND

MeSH Terms

Interventions

Rabeprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Todd A Loehrl, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: June 1, 2002
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: January 30, 2017

Record last verified: 2013-11

Locations

US (1)