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| Sponsor: | American Institute for Voice and Ear Research |
|---|---|
| Information provided by (Responsible Party): | Robert T. Sataloff, MD, American Institute for Voice and Ear Research |
| ClinicalTrials.gov Identifier: | NCT00369265 |
Purpose
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 Dietary Supplement: Sugar pill |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | A Randomized, Placebo-Controlled Assessment of Lansoprazole 30 mg Bid in the Treatment of Gastroesophageal Reflux Associated With Laryngitis |
| Enrollment: | 18 |
| Study Start Date: | August 2006 |
| Study Completion Date: | November 2009 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Lansoprazole
Lansoprazole 30 mg Twice Daily
|
Drug: Lansoprazole
Lansoprazole 30mg twice daily
|
|
Placebo Comparator: Sugar pill
placebo
|
Dietary Supplement: Sugar pill
placebo twice daily
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 89 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Michigan | |
| Henry Ford Hospital, Department of Otolaryngology | |
| Detroit, Michigan, United States, 48202-2699 | |
| United States, Pennsylvania | |
| American Institute for Voice and Ear Research | |
| Philadelphia, Pennsylvania, United States, 19103 | |
| United States, Texas | |
| Cornell University, Van Lawrence Voice Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Robert T Sataloff, MD, DMA | American Institute for Voice and Ear Research |
More Information
| Responsible Party: | Robert T. Sataloff, MD, M.D., D.M.A., FACS, American Institute for Voice and Ear Research |
| ClinicalTrials.gov Identifier: | NCT00369265 History of Changes |
| Other Study ID Numbers: | 10166 |
| Study First Received: | August 24, 2006 |
| Last Updated: | January 26, 2012 |
| Health Authority: | United States: Institutional Review Board |
|
Gastroesophageal reflux Laryngitis Hoarseness Dysphonia Proton pump inhibitor |
|
Gastroesophageal Reflux Laryngitis Regurgitation, Gastric Esophageal Motility Disorders Deglutition Disorders Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Laryngeal Diseases Respiratory Tract Diseases Respiratory Tract Infections |
Otorhinolaryngologic Diseases Lansoprazole Proton Pump Inhibitors Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Anti-Ulcer Agents Gastrointestinal Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |