Laryngopharyngeal RefluxPhase 4NCT00369265
Safety and Efficacy of Lansoprazole 30mg Twice Daily in Treatment of Laryngitis Associated With Gastroesophageal Reflux
A Phase 4 study testing Lansoprazole and Sugar pill in people with Laryngopharyngeal Reflux, run by American Institute for Voice and Ear Research at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Laryngopharyngeal Reflux
- What is being tested?
- Lansoprazole and Sugar pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2006to Nov 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Henry Ford Hospital, Department of Otolaryngology
Detroit, Michigan, 48202-2699
Cornell University, Van Lawrence Voice Center
Houston, Texas, 77030
American Institute for Voice and Ear Research
Philadelphia, Pennsylvania, 19103
About this study
Official title: A Randomized, Placebo-Controlled Assessment of Lansoprazole 30 mg Bid in the Treatment of Gastroesophageal Reflux Associated With Laryngitis
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.
Read the 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.
- Conditions
- Laryngopharyngeal Reflux
- Being tested
- Lansoprazole, Sugar pill
- Keywords
- Gastroesophageal reflux, Laryngitis, Hoarseness, Dysphonia, Proton pump inhibitor
- Medical subject headings
- Laryngopharyngeal Reflux, Gastroesophageal Reflux, Laryngitis, Hoarseness, Dysphonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LansoprazoleDrug
Lansoprazole 30mg twice daily
Sugar pillDietary supplement
placebo twice daily
| Study group | Role | What they receive |
|---|---|---|
| Lansoprazole | Experimental | Lansoprazole 30 mg Twice Daily Receives: Drug: Lansoprazole |
| Sugar pill | Placebo comparator | placebo Receives: Dietary Supplement: Sugar pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Improvement or Resolution of Arytenoid Erythema
Improvement was measured by score on an arytenoid erythema grading scale assigned by member of research staff and independent observers at 6 weeks
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2006 (estimated)
- Study startAug 2006
- Primary completionNov 2009
- Study completionNov 2009
Why it stopped: Pharmaceutical company purchased by another company and funding was terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Laryngopharyngeal RefluxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Institute for Voice and Ear Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert T. Sataloff, MD, American Institute for Voice and Ear Research
- Investigators
- Robert T Sataloff, MD, DMA, Principal investigator, American Institute for Voice and Ear Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00369265
- Sponsor's protocol ID
- 10166
- Status last verified
- Aug 2012
- First submitted
- 24 Aug 2006
- Last updated
- 24 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 12150380Belafsky 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.
PubMed 11404607Bogdasarian 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.
PubMed 7208045Cherry J, Margulies SI. Contact ulcer of the larynx. Laryngoscope. 1968 Nov;78(11):1937-40. doi: 10.1288/00005537-196811000-00007. No abstract available.
PubMed 5722896Delahunty JE, Cherry J. Experimentally produced vocal cord granulomas. Laryngoscope. 1968 Nov;78(11):1941-7. doi: 10.1288/00005537-196811000-00008. No abstract available.
PubMed 5722897Eherer 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.
PubMed 12795454El-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.
PubMed 11316215Koufman 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.
PubMed 8865091Morrison 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.
PubMed 3148885Noordzij 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.
PubMed 11802014Vaezi 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.
PubMed 16467715Wetmore 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.
PubMed 8231577
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled Assessment of Lansoprazole 30 mg Bid in the Treatment of Gastroesophageal Reflux Associated With Laryngitis
- ClinicalTrials.gov ID
- NCT00369265
- Acronym / sponsor ID
- 10166
- Conditions
- Laryngopharyngeal Reflux
- Keywords
- Gastroesophageal reflux, Laryngitis, Hoarseness, Dysphonia, Proton pump inhibitor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Pharmaceutical company purchased by another company and funding was terminated.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- American Institute for Voice and Ear ResearchUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 29 Aug 2006 (estimated)
- Results
- Posted 17 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lansoprazole | Experimental | Drug: LansoprazoleLansoprazole 30 mg Twice Daily |
| Sugar pill | Placebo comparator | Dietary Supplement: Sugar pillplacebo |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LansoprazoleLansoprazole 30mg twice daily | Drug | Lansoprazole |
| Sugar pillplacebo twice daily | Dietary supplement | Sugar pill |
Primary outcome
Percentage of Participants With Improvement or Resolution of Arytenoid Erythema
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12150380Belafsky 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.
- Background: PubMed 11404607Belafsky 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.
- Background: PubMed 7208045Bogdasarian 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.
- Background: PubMed 5722896Cherry J, Margulies SI. Contact ulcer of the larynx. Laryngoscope. 1968 Nov;78(11):1937-40. doi: 10.1288/00005537-196811000-00007. No abstract available.
- Background: PubMed 5722897Delahunty JE, Cherry J. Experimentally produced vocal cord granulomas. Laryngoscope. 1968 Nov;78(11):1941-7. doi: 10.1288/00005537-196811000-00008. No abstract available.
- Background: PubMed 12795454Eherer 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.
- Background: PubMed 11316215El-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.
- Background: PubMed 8865091Koufman 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.
- Background: PubMed 3148885Morrison 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.
- Background: PubMed 11802014Noordzij 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.
- Background: PubMed 16467715Vaezi 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.
- Background: PubMed 8231577Wetmore 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert T Sataloff, MD, DMA principal investigator
American Institute for Voice and Ear Research
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lansoprazole and Sugar pill in people with Laryngopharyngeal Reflux, run by American Institute for Voice and Ear Research at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Improvement or Resolution of Arytenoid Erythema (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00369265, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2012.