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

NCT ID: NCT00369265

Last Updated: 2012-08-24

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2009-11-30

Brief Summary

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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

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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.

Conditions

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Laryngopharyngeal Reflux

Keywords

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Gastroesophageal reflux Laryngitis Hoarseness Dysphonia Proton pump inhibitor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Lansoprazole

Lansoprazole 30 mg Twice Daily

Group Type EXPERIMENTAL

Lansoprazole

Intervention Type DRUG

Lansoprazole 30mg twice daily

Sugar pill

placebo

Group Type PLACEBO_COMPARATOR

Sugar pill

Intervention Type DIETARY_SUPPLEMENT

placebo twice daily

Interventions

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Lansoprazole

Lansoprazole 30mg twice daily

Intervention Type DRUG

Sugar pill

placebo twice daily

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Institute for Voice and Ear Research

OTHER

Sponsor Role lead

Responsible Party

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Robert T. Sataloff, MD

M.D., D.M.A., FACS

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert T Sataloff, MD, DMA

Role: PRINCIPAL_INVESTIGATOR

American Institute for Voice and Ear Research

Locations

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Henry Ford Hospital, Department of Otolaryngology

Detroit, Michigan, United States

Site Status

American Institute for Voice and Ear Research

Philadelphia, Pennsylvania, United States

Site Status

Cornell University, Van Lawrence Voice Center

Houston, Texas, United States

Site Status

Countries

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United States

References

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Belafsky PC, Postma GN, Koufman JA. Validity and reliability of the reflux symptom index (RSI). J Voice. 2002 Jun;16(2):274-7. doi: 10.1016/s0892-1997(02)00097-8.

Reference Type BACKGROUND
PMID: 12150380 (View on PubMed)

Belafsky PC, Postma GN, Koufman JA. Laryngopharyngeal reflux symptoms improve before changes in physical findings. Laryngoscope. 2001 Jun;111(6):979-81. doi: 10.1097/00005537-200106000-00009.

Reference Type BACKGROUND
PMID: 11404607 (View on PubMed)

Bogdasarian RS, Olson NR. Posterior glottic laryngeal stenosis. Otolaryngol Head Neck Surg (1979). 1980 Nov-Dec;88(6):765-72. doi: 10.1177/019459988008800625. No abstract available.

Reference Type BACKGROUND
PMID: 7208045 (View on PubMed)

Cherry J, Margulies SI. Contact ulcer of the larynx. Laryngoscope. 1968 Nov;78(11):1937-40. doi: 10.1288/00005537-196811000-00007. No abstract available.

Reference Type BACKGROUND
PMID: 5722896 (View on PubMed)

Delahunty JE, Cherry J. Experimentally produced vocal cord granulomas. Laryngoscope. 1968 Nov;78(11):1941-7. doi: 10.1288/00005537-196811000-00008. No abstract available.

Reference Type BACKGROUND
PMID: 5722897 (View on PubMed)

Eherer AJ, Habermann W, Hammer HF, Kiesler K, Friedrich G, Krejs GJ. Effect of pantoprazole on the course of reflux-associated laryngitis: a placebo-controlled double-blind crossover study. Scand J Gastroenterol. 2003 May;38(5):462-7. doi: 10.1080/00365520310001860.

Reference Type BACKGROUND
PMID: 12795454 (View on PubMed)

El-Serag HB, Lee P, Buchner A, Inadomi JM, Gavin M, McCarthy DM. Lansoprazole treatment of patients with chronic idiopathic laryngitis: a placebo-controlled trial. Am J Gastroenterol. 2001 Apr;96(4):979-83. doi: 10.1111/j.1572-0241.2001.03681.x.

Reference Type BACKGROUND
PMID: 11316215 (View on PubMed)

Koufman J, Sataloff RT, Toohill R. Laryngopharyngeal reflux: consensus conference report. J Voice. 1996 Sep;10(3):215-6. doi: 10.1016/s0892-1997(96)80001-4. No abstract available.

Reference Type BACKGROUND
PMID: 8865091 (View on PubMed)

Morrison MD. Is chronic gastroesophageal reflux a causative factor in glottic carcinoma? Otolaryngol Head Neck Surg. 1988 Oct;99(4):370-3. doi: 10.1177/019459988809900403.

Reference Type BACKGROUND
PMID: 3148885 (View on PubMed)

Noordzij JP, Khidr A, Evans BA, Desper E, Mittal RK, Reibel JF, Levine PA. Evaluation of omeprazole in the treatment of reflux laryngitis: a prospective, placebo-controlled, randomized, double-blind study. Laryngoscope. 2001 Dec;111(12):2147-51. doi: 10.1097/00005537-200112000-00013.

Reference Type BACKGROUND
PMID: 11802014 (View on PubMed)

Vaezi MF, Richter JE, Stasney CR, Spiegel JR, Iannuzzi RA, Crawley JA, Hwang C, Sostek MB, Shaker R. Treatment of chronic posterior laryngitis with esomeprazole. Laryngoscope. 2006 Feb;116(2):254-60. doi: 10.1097/01.mlg.0000192173.00498.ba.

Reference Type BACKGROUND
PMID: 16467715 (View on PubMed)

Wetmore RF. Effects of acid on the larynx of the maturing rabbit and their possible significance to the sudden infant death syndrome. Laryngoscope. 1993 Nov;103(11 Pt 1):1242-54. doi: 10.1288/00005537-199311000-00006.

Reference Type BACKGROUND
PMID: 8231577 (View on PubMed)

Other Identifiers

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10166

Identifier Type: -

Identifier Source: org_study_id