Official Title: “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 Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: Lansoprazole

Primary Measures

• Improvement or resolution of arytenoid erythema; score on an arytenoid erythema grading scale assigned by member of research staff and independent observers at 6 weeks.

Secondary Measures

• Voice quality assessed subjectively and objectively at 6 weeks.
• Reflux symptoms assessed by patients' completion of Reflux Symptom Index at 6 weeks.
• Quality of life assessed by patient questionnaire at 6 weeks.
• Standard objective voice measures performed by member of research staff at 6 weeks.
• Safety and efficacy of Lansoprazole on non-acid laryngopharyngeal reflux will be studied in open-labeled, uncontrolled, single group, sub-study of 30 patients using the same primary and secondary outcome measures.

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: American Institute for Voice and Ear Research

Overall Clinical Trial Officials and Contacts

Robert T Sataloff, MD, DMA Principal Investigator American Institute for Voice and Ear Research  

Overall Contact: Robert T Sataloff, MD, DMA 215-545-3322 RTSataloff@PhillyENT.com

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00369265

Study ID Number: 10166

ClinicalTrials.gov Identifier: NCT00369265

Health Authority: United States: Institutional Review Board