A Randomized, Placebo-Controlled Assessment of Lansoprazole 30 mg Bid in the Treatment of Gastroesophageal Reflux Associated With Laryngitis
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 3
- 主要终点
- Percentage of Participants With Improvement or Resolution of Arytenoid Erythema
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Lansoprazole
Lansoprazole 30 mg Twice Daily
干预措施: Lansoprazole (Drug)
Sugar pill
placebo
干预措施: Sugar pill (Dietary Supplement)
结局指标
主要结局
Percentage of Participants With Improvement or Resolution of Arytenoid Erythema
时间窗: 6 weeks
Improvement was measured by score on an arytenoid erythema grading scale assigned by member of research staff and independent observers at 6 weeks
次要结局
未报告次要终点
研究者
Robert T. Sataloff, MD
M.D., D.M.A., FACS
American Institute for Voice and Ear Research