Eosinophilic EsophagitisPhase 1NCT00511316
Trial of Montelukast in Eosinophilic Esophagitis
A Phase 1 study testing Montelukast/ Singulair in people with Eosinophilic Esophagitis, run by Mayo Clinic at 1 site in United States.
Trial summary
Evaluate clinical effectiveness of oral montelukast compared to placebo on prevention of dysphagia and food impaction in patients with EE. Also evaluate tolerance and safety of oral montelukast in treatment of EE. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Eosinophilic Esophagitis
- What is being tested?
- Montelukast/ Singulair
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Sep 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- > 14 eosinophils / hpf on biopsies from mid esophagus within the 6 months.
- Abnormal dysphagia questionnaire (Question 1a yes, question 1c >/= mild and question 2 >/= less than once a week) prior to topical steroid treatment. This questionnaire has recently been validated.
- Normal dysphagia questionnaire after topical steroid treatment (Having an answer of no to question 1a: Have you had trouble swallowing, not associated with other cold symptoms? over the past two weeks since having completed the swallowed steroid treatment).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Placebo-Controlled Trial of Montelukast in Maintenance Therapy of Asymptomatic Eosinophilic Esophagitis
Evaluate clinical effectiveness of oral montelukast compared to placebo on prevention of dysphagia and food impaction in patients with EE.
Also evaluate tolerance and safety of oral montelukast in treatment of EE.
Read the detailed description
We will randomize in a double blind manner 60 consecutive consenting patients being evaluated at the three Mayo Clinic Medical Centers with EE to montelukast 20mg daily or placebo daily for six months? time. Patients will be in remission after treatment with topical fluticasone therapy before enrollment. Patients will fill out a validated dysphagia and side effect questionnaire before, during, and at the end of therapy.
- Conditions
- Eosinophilic Esophagitis
- Being tested
- Montelukast/ Singulair, Placebo
- Medical subject headings
- Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Montelukast/ SingulairDrug
Also called Singulair
20 mg daily for six months
PlaceboDrug
Placebo 20 mg daily for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Drug | Experimental | 20 mg montelukast daily for 6 months Receives: Drug: Montelukast/ Singulair |
| Placebo | Placebo comparator | 20 mg daily placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate effectiveness of oral montelukast in treatment of EE.
Measured: 6 months
Secondary outcomes (1)
evaluate safety of montelukast in eosinophilic esophagitis
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eosinophilic EsophagitisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Jeffrey A Alexander, Mayo Clinic
- Investigators
- Jeffrey A. Alexander, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00511316
- Sponsor's protocol ID
- 06-003373
- Status last verified
- Nov 2015
- First submitted
- 1 Aug 2007
- Last updated
- 3 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Alexander JA, Ravi K, Enders FT, Geno DM, Kryzer LA, Mara KC, Smyrk TC, Katzka DA. Montelukast Does not Maintain Symptom Remission After Topical Steroid Therapy for Eosinophilic Esophagitis. Clin Gastroenterol Hepatol. 2017 Feb;15(2):214-221.e2. doi: 10.1016/j.cgh.2016.09.013. Epub 2016 Sep 17.
PubMed 27650328
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Placebo-Controlled Trial of Montelukast in Maintenance Therapy of Asymptomatic Eosinophilic Esophagitis
- ClinicalTrials.gov ID
- NCT00511316
- Acronym / sponsor ID
- 06-003373
- Conditions
- Eosinophilic Esophagitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Aug 2007
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 3 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate clinical effectiveness of oral montelukast compared to placebo on prevention of dysphagia and food impaction in patients with EE.
Also evaluate tolerance and safety of oral montelukast in treatment of EE.
Detailed description
We will randomize in a double blind manner 60 consecutive consenting patients being evaluated at the three Mayo Clinic Medical Centers with EE to montelukast 20mg daily or placebo daily for six months? time. Patients will be in remission after treatment with topical fluticasone therapy before enrollment. Patients will fill out a validated dysphagia and side effect questionnaire before, during, and at the end of therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug | Experimental | Drug: Montelukast/ Singulair20 mg montelukast daily for 6 months |
| Placebo | Placebo comparator | Drug: Placebo20 mg daily placebo |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older
- > 14 eosinophils / hpf on biopsies from mid esophagus within the 6 months.
- Abnormal dysphagia questionnaire (Question 1a yes, question 1c >/= mild and question 2 >/= less than once a week) prior to topical steroid treatment. This questionnaire has recently been validated.
- Normal dysphagia questionnaire after topical steroid treatment (Having an answer of no to question 1a: Have you had trouble swallowing, not associated with other cold symptoms? over the past two weeks since having completed the swallowed steroid treatment).
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Montelukast/ SingulairAlso: Singulair20 mg daily for six months | Drug | Drug |
| PlaceboPlacebo 20 mg daily for 6 months | Drug | Placebo |
Primary outcome
evaluate effectiveness of oral montelukast in treatment of EE.
Time frame: 6 months
1 secondary outcome
evaluate safety of montelukast in eosinophilic esophagitis
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2015.
- Derived from this study: PubMed 27650328Alexander JA, Ravi K, Enders FT, Geno DM, Kryzer LA, Mara KC, Smyrk TC, Katzka DA. Montelukast Does not Maintain Symptom Remission After Topical Steroid Therapy for Eosinophilic Esophagitis. Clin Gastroenterol Hepatol. 2017 Feb;15(2):214-221.e2. doi: 10.1016/j.cgh.2016.09.013. Epub 2016 Sep 17.
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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.
Jeffrey A. Alexander, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Montelukast/ Singulair in people with Eosinophilic Esophagitis, run by Mayo Clinic at 1 site 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 4 inclusion and 0 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: finished, as of the sponsor's last update on 3 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
evaluate effectiveness of oral montelukast in treatment of EE. (time frame: 6 months). 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 NCT00511316, which also lists 1 linked publication.
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 3 Nov 2015.