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Safety and Efficacy of Lansoprazole 30mg Twice Daily in Treatment of Laryngitis Associated With Gastroesophageal Reflux

Primary Purpose

Laryngopharyngeal Reflux

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Lansoprazole
Sugar pill
Sponsored by
American Institute for Voice and Ear Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Laryngopharyngeal Reflux focused on measuring Gastroesophageal reflux, Laryngitis, Hoarseness, Dysphonia, Proton pump inhibitor

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Vocal skills necessary to complete test procedures reliably. Voice complaints and/or other symptoms suggestive of reflux laryngitis Signed informed consent At least 18 years of age. Complete medical history and physical examination within 30 days prior to initiation of the study drug. Laryngoscopy documenting laryngeal pathology compatible with moderate to severe reflux laryngitis (> grade 3 arytenoid erythema) within 30 days of initiation of the study drug. Gastroesophageal reflux confirmed by 24-hour (a minimum of 16 hours required for inclusion) pH impedance monitor. Ambulatory outpatient status. If female, a negative pregnancy test at the screening visit or either: i) surgically sterilized (bilateral tubal ligation or hysterectomy), or ii) at least 1 year post-menopausal, or iii) using acceptable methods of contraception in the presence of childbearing potential. Exclusion Criteria: Concurrent laryngeal disease, if such disease or its treatment would interfere with evaluation of study results. For example, patients with mass lesions such as laryngeal cysts or laryngeal carcinoma will be excluded. Patients with acute laryngeal infections or acute laryngeal allergies will be excluded until these conditions have been resolved; but they may be considered for inclusion thereafter. Any upper gastroenterological or esophageal surgery except simple over-sewing of a perforated ulcer. Active substance abuse. Tobacco use. Known hypersensitivity or allergy to any protein pump inhibitor. ALT (SGPT) or AST (SGOT) greater than 2 times the upper limit of normal. Renal impairment (serum creatinine > 2.0 mg/dl). Any clinically significant, unstable medical condition. Use of any proton pump inhibitor within 7 days prior to 24-hour pH impedance monitoring or baseline strobovideolaryngoscopy, or use of H2 receptor antagonist during the 48 hours prior to 24-hour pH impedance monitoring or baseline strobovideolaryngoscopy. Use of an investigational drug or participation in an investigational study, within 30 days prior to starting study drug. Previous participation in this study. Pregnant women. Women breast feeding infants. Inability or refusal to follow directions. Open label sub-study has same inclusion and exclusion criteria, with exception that subjects should have: 1) Clinical diagnosis of non-acid reflux, with less than 5 episodes of proximal acid reflux, and 2) Symptoms and signs consistent with gastroesophageal reflux.

Sites / Locations

  • Henry Ford Hospital, Department of Otolaryngology
  • American Institute for Voice and Ear Research
  • Cornell University, Van Lawrence Voice Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lansoprazole

Sugar pill

Arm Description

Lansoprazole 30 mg Twice Daily

placebo

Outcomes

Primary Outcome Measures

Percentage of Participants With Improvement or Resolution of Arytenoid Erythema
Improvement was measured by score on an arytenoid erythema grading scale assigned by member of research staff and independent observers at 6 weeks

Secondary Outcome Measures

Full Information

First Posted
August 24, 2006
Last Updated
August 23, 2012
Sponsor
American Institute for Voice and Ear Research
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1. Study Identification

Unique Protocol Identification Number
NCT00369265
Brief Title
Safety and Efficacy of Lansoprazole 30mg Twice Daily in Treatment of Laryngitis Associated With Gastroesophageal Reflux
Official Title
A Randomized, Placebo-Controlled Assessment of Lansoprazole 30 mg Bid in the Treatment of Gastroesophageal Reflux Associated With Laryngitis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Terminated
Why Stopped
Pharmaceutical company purchased by another company and funding was terminated.
Study Start Date
August 2006 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
American Institute for Voice and Ear Research

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to determine whether Lansoprazole 30mg taken twice daily is effective in the treatment of laryngitis due to gastroesophageal reflux.
Detailed Description
The investigators propose to study the effect of Lansoprazole 30 mg bid therapy vs. placebo in patients who present with symptoms characteristic of reflux laryngitis. The efficacy of Lansoprazole 30 mg bid in healing and improving reflux laryngitis will be determined. For the purpose of this study, healed reflux laryngitis will be defined as an improvement or resolution of arytenoid erythema and improvement in symptoms. Improved reflux laryngitis will be defined as improvement in any two of the following areas: arytenoid erythema; voice quality as assessed by the patients or health care provider; or, improvement/resolution of related symptoms (throat clearing, cough, etc.). The impact of Lansoprazole 30 mg bid therapy on quality of life will be evaluated in a preliminary fashion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laryngopharyngeal Reflux
Keywords
Gastroesophageal reflux, Laryngitis, Hoarseness, Dysphonia, Proton pump inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lansoprazole
Arm Type
Experimental
Arm Description
Lansoprazole 30 mg Twice Daily
Arm Title
Sugar pill
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
Lansoprazole
Intervention Description
Lansoprazole 30mg twice daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Sugar pill
Intervention Description
placebo twice daily
Primary Outcome Measure Information:
Title
Percentage of Participants With Improvement or Resolution of Arytenoid Erythema
Description
Improvement was measured by score on an arytenoid erythema grading scale assigned by member of research staff and independent observers at 6 weeks
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Vocal skills necessary to complete test procedures reliably. Voice complaints and/or other symptoms suggestive of reflux laryngitis Signed informed consent At least 18 years of age. Complete medical history and physical examination within 30 days prior to initiation of the study drug. Laryngoscopy documenting laryngeal pathology compatible with moderate to severe reflux laryngitis (> grade 3 arytenoid erythema) within 30 days of initiation of the study drug. Gastroesophageal reflux confirmed by 24-hour (a minimum of 16 hours required for inclusion) pH impedance monitor. Ambulatory outpatient status. If female, a negative pregnancy test at the screening visit or either: i) surgically sterilized (bilateral tubal ligation or hysterectomy), or ii) at least 1 year post-menopausal, or iii) using acceptable methods of contraception in the presence of childbearing potential. Exclusion Criteria: Concurrent laryngeal disease, if such disease or its treatment would interfere with evaluation of study results. For example, patients with mass lesions such as laryngeal cysts or laryngeal carcinoma will be excluded. Patients with acute laryngeal infections or acute laryngeal allergies will be excluded until these conditions have been resolved; but they may be considered for inclusion thereafter. Any upper gastroenterological or esophageal surgery except simple over-sewing of a perforated ulcer. Active substance abuse. Tobacco use. Known hypersensitivity or allergy to any protein pump inhibitor. ALT (SGPT) or AST (SGOT) greater than 2 times the upper limit of normal. Renal impairment (serum creatinine > 2.0 mg/dl). Any clinically significant, unstable medical condition. Use of any proton pump inhibitor within 7 days prior to 24-hour pH impedance monitoring or baseline strobovideolaryngoscopy, or use of H2 receptor antagonist during the 48 hours prior to 24-hour pH impedance monitoring or baseline strobovideolaryngoscopy. Use of an investigational drug or participation in an investigational study, within 30 days prior to starting study drug. Previous participation in this study. Pregnant women. Women breast feeding infants. Inability or refusal to follow directions. Open label sub-study has same inclusion and exclusion criteria, with exception that subjects should have: 1) Clinical diagnosis of non-acid reflux, with less than 5 episodes of proximal acid reflux, and 2) Symptoms and signs consistent with gastroesophageal reflux.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert T Sataloff, MD, DMA
Organizational Affiliation
American Institute for Voice and Ear Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henry Ford Hospital, Department of Otolaryngology
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202-2699
Country
United States
Facility Name
American Institute for Voice and Ear Research
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Facility Name
Cornell University, Van Lawrence Voice Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12150380
Citation
Belafsky PC, Postma GN, Koufman JA. Validity and reliability of the reflux symptom index (RSI). J Voice. 2002 Jun;16(2):274-7. doi: 10.1016/s0892-1997(02)00097-8.
Results Reference
background
PubMed Identifier
11404607
Citation
Belafsky PC, Postma GN, Koufman JA. Laryngopharyngeal reflux symptoms improve before changes in physical findings. Laryngoscope. 2001 Jun;111(6):979-81. doi: 10.1097/00005537-200106000-00009.
Results Reference
background
PubMed Identifier
7208045
Citation
Bogdasarian RS, Olson NR. Posterior glottic laryngeal stenosis. Otolaryngol Head Neck Surg (1979). 1980 Nov-Dec;88(6):765-72. doi: 10.1177/019459988008800625. No abstract available.
Results Reference
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PubMed Identifier
5722896
Citation
Cherry J, Margulies SI. Contact ulcer of the larynx. Laryngoscope. 1968 Nov;78(11):1937-40. doi: 10.1288/00005537-196811000-00007. No abstract available.
Results Reference
background
PubMed Identifier
5722897
Citation
Delahunty JE, Cherry J. Experimentally produced vocal cord granulomas. Laryngoscope. 1968 Nov;78(11):1941-7. doi: 10.1288/00005537-196811000-00008. No abstract available.
Results Reference
background
PubMed Identifier
12795454
Citation
Eherer AJ, Habermann W, Hammer HF, Kiesler K, Friedrich G, Krejs GJ. Effect of pantoprazole on the course of reflux-associated laryngitis: a placebo-controlled double-blind crossover study. Scand J Gastroenterol. 2003 May;38(5):462-7. doi: 10.1080/00365520310001860.
Results Reference
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PubMed Identifier
11316215
Citation
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.
Results Reference
background
PubMed Identifier
8865091
Citation
Koufman J, Sataloff RT, Toohill R. Laryngopharyngeal reflux: consensus conference report. J Voice. 1996 Sep;10(3):215-6. doi: 10.1016/s0892-1997(96)80001-4. No abstract available.
Results Reference
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PubMed Identifier
3148885
Citation
Morrison MD. Is chronic gastroesophageal reflux a causative factor in glottic carcinoma? Otolaryngol Head Neck Surg. 1988 Oct;99(4):370-3. doi: 10.1177/019459988809900403.
Results Reference
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PubMed Identifier
11802014
Citation
Noordzij JP, Khidr A, Evans BA, Desper E, Mittal RK, Reibel JF, Levine PA. Evaluation of omeprazole in the treatment of reflux laryngitis: a prospective, placebo-controlled, randomized, double-blind study. Laryngoscope. 2001 Dec;111(12):2147-51. doi: 10.1097/00005537-200112000-00013.
Results Reference
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PubMed Identifier
16467715
Citation
Vaezi MF, Richter JE, Stasney CR, Spiegel JR, Iannuzzi RA, Crawley JA, Hwang C, Sostek MB, Shaker R. Treatment of chronic posterior laryngitis with esomeprazole. Laryngoscope. 2006 Feb;116(2):254-60. doi: 10.1097/01.mlg.0000192173.00498.ba.
Results Reference
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PubMed Identifier
8231577
Citation
Wetmore RF. Effects of acid on the larynx of the maturing rabbit and their possible significance to the sudden infant death syndrome. Laryngoscope. 1993 Nov;103(11 Pt 1):1242-54. doi: 10.1288/00005537-199311000-00006.
Results Reference
background

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Safety and Efficacy of Lansoprazole 30mg Twice Daily in Treatment of Laryngitis Associated With Gastroesophageal Reflux

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