Clinical trial NCT00369265: Safety and Efficacy of Lansoprazole 30mg Twice Daily in Treatment of Laryngitis Associated With Gastroesophageal Reflux
Official title: A Randomized, Placebo-Controlled Assessment of Lansoprazole 30 mg Bid in the Treatment of Gastroesophageal Reflux Associated With Laryngitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Laryngopharyngeal Reflux
Keywords: Gastroesophageal reflux
Laryngitis
Hoarseness
Dysphonia
Proton pump inhibitor
Lead sponsor: American Institute for Voice and Ear Research
Sponsor class: OTHER
First posted: 2006-08-29
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: Percentage of Participants With Improvement or Resolution of Arytenoid Erythema
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Hospital, Department of Otolaryngology
state: Michigan
city: Philadelphia
country: United States
facility: American Institute for Voice and Ear Research
state: Pennsylvania
city: Houston
country: United States
facility: Cornell University, Van Lawrence Voice Center
state: Texas
Study officials:
affiliation: American Institute for Voice and Ear Research
name: Robert T Sataloff, MD, DMA
role: PRINCIPAL_INVESTIGATOR
References:
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