Eosinophilic EsophagitisPhase 2NCT00638456
Use of Topical Budesonide in the Treatment of Eosinophilic Esophagitis
A Phase 2 study testing Budesonide plus Prevacid in people with Eosinophilic Esophagitis, run by Ranjan Dohil at 1 site in United States.
Trial summary
This study is designed to evaluate whether or not oral viscous budesonide is effective in treating children with Eosinophilic Esophagitis. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Eosinophilic Esophagitis
- What is being tested?
- Budesonide plus Prevacid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Sep 2009
- Phase
- Phase 2
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histologic evidence of EE defined as greater than 20 eosinophils per hpf on esophageal biopsy
- Ages 1 yrs and older
- Ability to continue the same diet that the patient was on at the time of EGD with biopsy
Who cannot join
- Adverse reaction or allergy to budesonide
- Pregnancy
- Chronic diseases requiring immunomodulatory therapy
- Use of swallowed topical corticosteroids for EE within the past 3 months
- Use of systemic steroids 2 months prior to study entry
- Upper gastrointestinal bleed within 4 months of study entry
Show all 10Show fewer
- Chronic use of medications that predispose to upper gastrointestinal bleeding including non-steroidal anti-inflammatory medications or anticoagulants
- Evidence of adrenal suppression prior to study entry
- Evidence of concurrent eosinophilic gastritis, enteritis, colitis, or proctitis
- Recent changes in asthma or allergic rhinitis therapy for 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Rady Children's Hospital, San Diego
San Diego, California, 92123
About this study
Official title: Use of Topical Budesonide in the Treatment of Eosinophilic Esophagitis, a Randomized Clinical Trial
This study is designed to evaluate whether or not oral viscous budesonide is effective in treating children with Eosinophilic Esophagitis.
- Conditions
- Eosinophilic Esophagitis
- Being tested
- Budesonide plus Prevacid, placebo plus Prevacid
- Keywords
- Eosinophils, Esophagitis, Microscopy
- Medical subject headings
- Eosinophilic Esophagitis, Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Budesonide plus PrevacidDrug
Budesonide is taken daily for three months. In addition, Prevacid is taken twice daily for three months.
placebo plus PrevacidDrug
Placebo is taken daily for three months. In addition, Prevacid is taken twice daily for three months.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | oral viscous budesonide plus Prevacid Receives: Drug: Budesonide plus Prevacid |
| 2 | Placebo comparator | placebo plus Prevacid Receives: Drug: placebo plus Prevacid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Improvement of Espohageal Eosinophilia
Repeat endoscopy was undertaken using the Olympus P160 endoscope (by RD) at 3 months of treatment.
Measured: 3 Months
Secondary outcomes (2)
Upper Gastrointestinal Endoscopy Score
Endoscopy scoring tool took into account the following categories:
Mucosal pallor/reduced vasculature Linear furrows/mucosal thickening White plaques Concentric rings/stricture Friability/"tissue-paper" mucosa Histology scoring tools Epithelial histology score Peak eosinophil count
Each category could score 0-3 for a total maximum score of 15. The higher the score the worse the disease.
Measured: Baseline and 3 Months
Symptom Score
Total score was based on the following symptoms:
Heartburn/regurgitation Abdominal pain Nausea/vomiting Anorexia/early satiety Dysphagia Symptom induced nocturnal wakening Gastrointestinal bleeding
Each symptom could score 0-2 for a maximum score for 14 points. The lower the score the milder the symptoms and the higher the score the more severe symptoms.
Measured: Baseline and 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionSep 2009
- Study completionSep 2009
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 (1)Papers the sponsor has linked to this study.
- Other trials for Eosinophilic EsophagitisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ranjan Dohil
- Sponsor type
- University, hospital or other
- Collaborators
- Meritage Pharma, Inc.
- Responsible party
- Sponsor-investigator, Ranjan Dohil, University of California, San Diego
- Investigators
- Ranjan Dohil, MD, Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00638456
- Sponsor's protocol ID
- VPI-106-01
- Status last verified
- Jul 2019
- First submitted
- 12 Mar 2008
- Last updated
- 14 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Dohil R, Newbury R, Fox L, Bastian J, Aceves S. Oral viscous budesonide is effective in children with eosinophilic esophagitis in a randomized, placebo-controlled trial. Gastroenterology. 2010 Aug;139(2):418-29. doi: 10.1053/j.gastro.2010.05.001. Epub 2010 May 7.
PubMed 20457157
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Topical Budesonide in the Treatment of Eosinophilic Esophagitis, a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00638456
- Acronym / sponsor ID
- VPI-106-01
- Conditions
- Eosinophilic Esophagitis
- Keywords
- Eosinophils, Esophagitis, Microscopy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Ranjan DohilUniversity, hospital or other
- Collaborators
- Meritage Pharma, Inc.
- Study start
- Feb 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 19 Mar 2008 (estimated)
- Results
- Posted 14 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to evaluate whether or not oral viscous budesonide is effective in treating children with Eosinophilic Esophagitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Budesonide plus Prevacidoral viscous budesonide plus Prevacid |
| 2 | Placebo comparator | Drug: placebo plus Prevacidplacebo plus Prevacid |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Histologic evidence of EE defined as greater than 20 eosinophils per hpf on esophageal biopsy
- Ages 1 yrs and older
- Ability to continue the same diet that the patient was on at the time of EGD with biopsy
Key exclusion criteria (10 listed)
- Adverse reaction or allergy to budesonide
- Pregnancy
- Chronic diseases requiring immunomodulatory therapy
- Use of swallowed topical corticosteroids for EE within the past 3 months
- Use of systemic steroids 2 months prior to study entry
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 |
|---|---|---|
| Budesonide plus PrevacidBudesonide is taken daily for three months. In addition, Prevacid is taken twice daily for three months. | Drug | 1 |
| placebo plus PrevacidPlacebo is taken daily for three months. In addition, Prevacid is taken twice daily for three months. | Drug | 2 |
Primary outcome
Number of Participants With Improvement of Espohageal Eosinophilia
Time frame: 3 Months
Repeat endoscopy was undertaken using the Olympus P160 endoscope (by RD) at 3 months of treatment.
2 secondary outcomes
Upper Gastrointestinal Endoscopy Score
Time frame: Baseline and 3 Months
Symptom Score
Time frame: Baseline and 3 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20457157Dohil R, Newbury R, Fox L, Bastian J, Aceves S. Oral viscous budesonide is effective in children with eosinophilic esophagitis in a randomized, placebo-controlled trial. Gastroenterology. 2010 Aug;139(2):418-29. doi: 10.1053/j.gastro.2010.05.001. Epub 2010 May 7.
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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.
Ranjan Dohil, MD principal investigator
UCSD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Budesonide plus Prevacid in people with Eosinophilic Esophagitis, run by Ranjan Dohil 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 3 inclusion and 10 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 14 Aug 2019. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 14 Aug 2019). 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?
Number of Participants With Improvement of Espohageal Eosinophilia (time frame: 3 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 NCT00638456, 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 14 Aug 2019.