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Sponsored by: |
American Institute for Voice and Ear Research |
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Information provided by: | American Institute for Voice and Ear Research |
ClinicalTrials.gov Identifier: | NCT00369265 |
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.
Condition | Intervention | Phase |
---|---|---|
Laryngopharyngeal Reflux |
Drug: Lansoprazole |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Placebo-Controlled Assessment of Lansoprazole 30 mg Bid in the Treatment of Gastroesophageal Reflux Associated With Laryngitis |
Estimated Enrollment: | 160 |
Study Start Date: | August 2006 |
Estimated Study Completion Date: | August 2006 |
We 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Robert T Sataloff, MD, DMA | 215-545-3322 | RTSataloff@PhillyENT.com |
Contact: Cynthia Watson, RN, BSN | 215-545-3322 |
United States, Michigan | |
Henry Ford Hospital, Department of Otolaryngology | Recruiting |
Detroit, Michigan, United States, 48202-2699 | |
Contact: Michael Benninger, MD 313-916-3275 | |
Contact: Tiffany Pierce (313) 916-1784 | |
Principal Investigator: Michael Benninger, MD | |
United States, Pennsylvania | |
American Institute for Voice and Ear Research | Recruiting |
Philadelphia, Pennsylvania, United States, 19103 | |
Contact: Robert T Sataloff, MD, DMA 215-545-3322 RTSataloff@PhillyENT.com | |
Contact: Cynthia Watson, RN, BSN 215-545-3322 | |
Principal Investigator: Robert T Sataloff, MD, DMA | |
United States, Texas | |
Cornell University, Van Lawrence Voice Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Richard Stasney, MD 713-796-2001 | |
Contact: Margarita Rodrigez 713-796-2001 | |
Principal Investigator: Richard Stasney, MD |
Principal Investigator: | Robert T Sataloff, MD, DMA | American Institute for Voice and Ear Research |
Study ID Numbers: | 10166 |
Study First Received: | August 24, 2006 |
Last Updated: | March 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00369265 |
Health Authority: | United States: Institutional Review Board |
Gastroesophageal reflux Laryngitis Hoarseness Dysphonia Proton pump inhibitor |
Otorhinolaryngologic Diseases Esophageal disorder Gastrointestinal Diseases Hoarseness Gastroesophageal Reflux Esophageal Motility Disorders Deglutition Disorders |
Digestive System Diseases Respiratory Tract Diseases Respiratory Tract Infections Laryngitis Lansoprazole Esophageal Diseases Laryngeal Diseases |
Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Anti-Ulcer Agents |
Gastrointestinal Agents Enzyme Inhibitors Pharmacologic Actions |