Safety and Efficacy of Lansoprazole 30mg Twice Daily in Treatment of Laryngitis Associated With Gastroesophageal Reflux

This study has been terminated.
(Pharmaceutical company purchased by another company and funding was terminated.)
Sponsor:
Information provided by (Responsible Party):
Robert T. Sataloff, MD, American Institute for Voice and Ear Research
ClinicalTrials.gov Identifier:
NCT00369265
First received: August 24, 2006
Last updated: August 23, 2012
Last verified: August 2012
  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 4

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

Resource links provided by NLM:


Further study details as provided by American Institute for Voice and Ear Research:

Primary Outcome Measures:
  • Percentage of Participants With Improvement or Resolution of Arytenoid Erythema [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Improvement was measured by score on an arytenoid erythema grading scale assigned by member of research staff and independent observers at 6 weeks


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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00369265

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
Sponsors and Collaborators
American Institute for Voice and Ear Research
Investigators
Principal Investigator: Robert T Sataloff, MD, DMA American Institute for Voice and Ear Research
  More Information

Publications:

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
Results First Received: July 11, 2012
Last Updated: August 23, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by American Institute for Voice and Ear Research:
Gastroesophageal reflux
Laryngitis
Hoarseness
Dysphonia
Proton pump inhibitor

Additional relevant MeSH terms:
Laryngitis
Gastroesophageal Reflux
Laryngopharyngeal Reflux
Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Lansoprazole
Dexlansoprazole
Proton Pump Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 31, 2014