- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00369265
Safety and Efficacy of Lansoprazole 30mg Twice Daily in Treatment of Laryngitis Associated With Gastroesophageal Reflux
August 23, 2012 updated by: Robert T. Sataloff, MD, American Institute for Voice and Ear Research
A Randomized, Placebo-Controlled Assessment of Lansoprazole 30 mg Bid in the Treatment of Gastroesophageal Reflux Associated With Laryngitis
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
-
Detroit, Michigan, United States, 48202-2699
- Henry Ford Hospital, Department of Otolaryngology
-
-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 19103
- American Institute for Voice and Ear Research
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-
Texas
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Houston, Texas, United States, 77030
- Cornell University, Van Lawrence Voice Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 89 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Sugar pill
placebo
|
placebo twice daily
|
Experimental: Lansoprazole
Lansoprazole 30 mg Twice Daily
|
Lansoprazole 30mg twice daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Improvement or Resolution of Arytenoid Erythema
Time Frame: 6 weeks
|
Improvement was measured by score on an arytenoid erythema grading scale assigned by member of research staff and independent observers at 6 weeks
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Robert T Sataloff, MD, DMA, American Institute for Voice and Ear Research
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2006
Primary Completion (Actual)
November 1, 2009
Study Completion (Actual)
November 1, 2009
Study Registration Dates
First Submitted
August 24, 2006
First Submitted That Met QC Criteria
August 24, 2006
First Posted (Estimate)
August 29, 2006
Study Record Updates
Last Update Posted (Estimate)
August 24, 2012
Last Update Submitted That Met QC Criteria
August 23, 2012
Last Verified
August 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Gastrointestinal Diseases
- Otorhinolaryngologic Diseases
- Esophageal Motility Disorders
- Deglutition Disorders
- Esophageal Diseases
- Laryngeal Diseases
- Gastroesophageal Reflux
- Laryngopharyngeal Reflux
- Laryngitis
- Croup
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Gastrointestinal Agents
- Anti-Ulcer Agents
- Proton Pump Inhibitors
- Dexlansoprazole
- Lansoprazole
Other Study ID Numbers
- 10166 (Other Identifier: CTEP)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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