Safety and Efficacy of Lansoprazole 30mg Twice Daily in Treatment of Laryngitis Associated With Gastroesophageal Reflux
Condition: Laryngopharyngeal Reflux
MeSH terms: Laryngitis; Gastroesophageal Reflux; Laryngopharyngeal Reflux; Croup
Intervention: Lansoprazole; Sugar pill
Intervention description: Lansoprazole 30mg twice daily; placebo twice daily
Intervention MeSH terms: Lansoprazole; Dexlansoprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 89 Years
Healthy volunteers: No
Keywords: Gastroesophageal reflux; Laryngitis; Hoarseness; Dysphonia; Proton pump inhibitor

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.
    

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.