Eosinophilic EsophagitisPhase 1/2NCT01386112
Safety and Tolerability Study of Oral EUR-1100 to Treat Eosinophilic Esophagitis
A Phase 1/2 study testing EUR-1100 in people with Eosinophilic Esophagitis, run by Forest Laboratories at 7 sites in United States.
Trial summary
Eosinophilic esophagitis (EoE) is an inflammatory disease of the esophagus, characterized by eosinophilic infiltration and gastrointestinal (GI) symptoms. There are no pharmacological treatments for EoE approved by the US Food and Drug Administration (FDA). Read more about this study
- Who is it for?
- Ages 12 to 55 years
- Conditions the study is for
- Eosinophilic Esophagitis
- What is being tested?
- EUR-1100
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 7 sitesUnited States
- Study dates
- Sep 2011to Oct 2012
- Phase
- Phase 1/2
- 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 12 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male and female subjects aged ≥ 12 and ≤ 55 years;
- Written informed consent (parent or guardian must sign when applicable) and assent form, if required;
- Evidence of eosinophilic esophagitis defined by esophageal mucosal eosinophil count greater than or equal to 24 per HPF (400x magnification) in at least 1 of the esophageal sites biopsied (proximal/middle and/or distal);
- Lack of histological response to previously administered high dose proton pump inhibitor;
- Clinical symptoms of eosinophilic esophagitis with at least one of the following symptoms: chest pain or discomfort, dysphagia (difficulty swallowing) or food impaction.
Who cannot join
- Known contraindication, hypersensitivity or intolerance to corticosteroids;
- Any physical, mental, or social condition, history of illness or laboratory abnormality that, in the investigator's judgment, might interfere with study procedures or the ability of the subject to adhere to and complete the study;
- Oral or esophageal mucosal infection of any type;
- Any condition affecting the esophageal mucosa or altering esophageal motility other than EoE;
- Use of systemic (oral or parenteral) or inhaled, intranasal or high-potency dermal topical corticosteroids in the 30 days prior to the esophageal biopsy required for entrance to this study (or prior to EGD if done during the pre-Screening period) or at any time between the biopsy and the Randomization Visit;
- Adrenal suppression;
Show all 15Show fewer
- Any medical condition in which the use of anti-inflammatory or immunosuppressant drugs are required or may be anticipated to be required during the study;
- Contraindication to EGD or esophageal biopsy or narrowing of the esophagus precluding EGD;
- History of esophageal or gastric surgery (history of esophageal dilatation is allowed);
- Gastrointestinal bleeding;
- Current chronic infection, immunosuppression, immunodeficiency;
- History or presence of Crohn's disease, celiac disease, or other inflammatory disease of the gastrointestinal tract;
- Alcohol or drug abuse;
- Female subjects who are pregnant or breastfeeding;
- Participation in a clinical study involving an investigational drug within 30 days of the Screening Visit.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Children's Center for Digestive Health
Atlanta, Georgia, 30342
Northwestern University School of Medicine
Chicago, Illinois, 60611-2951
O&O Alpan LLC Center for Clinical Trials
Fairfax, Virginia, 22030
Riley Hospital for Children
Indianapolis, Indiana, 46202
South Jersey Pediatric Gastroenterology
Mays Landing, New Jersey, 08330
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Safety and Tolerability Phase 1/2a Study of Two Dosing Regimens of EUR-1100 for Oral Use, in Subjects With Eosinophilic Esophagitis (EoE)
Eosinophilic esophagitis (EoE) is an inflammatory disease of the esophagus, characterized by eosinophilic infiltration and gastrointestinal (GI) symptoms. There are no pharmacological treatments for EoE approved by the US Food and Drug Administration (FDA). Supported by published case series and controlled trials in children and adults, the most widely used drug treatment for EoE is off-label use of corticosteroids intended for local (esophageal mucosal) action.
This study will evaluate the safety and tolerability of orally administered EUR-1100 once or twice daily. Eligible subjects will be randomized into one of the 3 treatment groups. The Treatment Period will be 8 weeks during which subjects will visit the clinic at the screening visit, randomization, week 4, 8 and 1 week after end of treatment for clinical symptom assessment and safety evaluation. Additional phone visits will occur at week 2 and week 6.
- Conditions
- Eosinophilic Esophagitis
- Being tested
- EUR-1100, 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.
EUR-1100Drug
Active oral medication
placeboDrug
matching placebo
| Study group | Role | What they receive |
|---|---|---|
| EUR-1100 1.5 mg | Experimental | Not described Receives: Drug: EUR-1100 |
| EUR-1100 3.0 mg | Experimental | Not described Receives: Drug: EUR-1100 |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morning serum cortisol (change from baseline measure)
Measured: Screening visit (up to 21 days), week 4, week 8 and follow-up
Standard safety laboratory tests
Hematology, serum chemistry and liver function tests, urinalysis, urine chemistry
Measured: Screening visit (up to 21 days), week 4, week 8 and follow-up
Treatment-emergent adverse events collection
Measured: Screening visit (up to 21 days), Randomization day, week 2 and week 6(phone visit), week 4 and week 8 (office visit), follow-up (office visit, up to 11 days after week 8 visit)
Physical examination and vital signs collection
Measured: Screening (up to 21 days), week4, week 8 and follow-up
Secondary outcomes (2)
Esophagoduodenoscopy with multiple biopsies
Measured: Screening (up to 21 days) and week 8
Patient reported outcomes, and physician global assessment
Measured: Screening (up to 21 days), week 4 and 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2011 (estimated)
- Study startSep 2011
- Primary completionOct 2012
- Study completionOct 2012
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.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forest Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ikuo Hirano, MD, Principal investigator, Northwestern University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01386112
- Sponsor's protocol ID
- PR-021
- Status last verified
- Oct 2012
- First submitted
- 28 Jun 2011
- Last updated
- 2 Nov 2012
- Results posted
- No
Publications
Schoepfer AM, Hirano I, Coslovsky M, Roumet MC, Zwahlen M, Kuehni CE, Hafner D, Alexander JA, Dellon ES, Gonsalves N, Leung J, Bussmann C, Collins MH, Newbury RO, Smyrk TC, Woosley JT, Yang GY, Romero Y, Katzka DA, Furuta GT, Gupta SK, Aceves SS, Chehade M, Spergel JM, Falk GW, Meltzer BA, Comer GM, Straumann A, Safroneeva E; International EEsAI Study Group. Variation in Endoscopic Activity Assessment and Endoscopy Score Validation in Adults With Eosinophilic Esophagitis. Clin Gastroenterol Hepatol. 2019 Jul;17(8):1477-1488.e10. doi: 10.1016/j.cgh.2018.11.032. Epub 2018 Nov 23.
PubMed 30476587
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled, Safety and Tolerability Phase 1/2a Study of Two Dosing Regimens of EUR-1100 for Oral Use, in Subjects With Eosinophilic Esophagitis (EoE)
- ClinicalTrials.gov ID
- NCT01386112
- Acronym / sponsor ID
- PR-021
- Conditions
- Eosinophilic Esophagitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Forest LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 30 Jun 2011 (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.
Eosinophilic esophagitis (EoE) is an inflammatory disease of the esophagus, characterized by eosinophilic infiltration and gastrointestinal (GI) symptoms. There are no pharmacological treatments for EoE approved by the US Food and Drug Administration (FDA). Supported by published case series and controlled trials in children and adults, the most widely used drug treatment for EoE is off-label use of corticosteroids intended for local (esophageal mucosal) action.
This study will evaluate the safety and tolerability of orally administered EUR-1100 once or twice daily. Eligible subjects will be randomized into one of the 3 treatment groups. The Treatment Period will be 8 weeks during which subjects will visit the clinic at the screening visit, randomization, week 4, 8 and 1 week after end of treatment for clinical symptom assessment and safety evaluation. Additional phone visits will occur at week 2 and week 6.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EUR-1100 1.5 mg | Experimental | Drug: EUR-1100 |
| EUR-1100 3.0 mg | Experimental | Drug: EUR-1100 |
| placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 12 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Male and female subjects aged ≥ 12 and ≤ 55 years;
- Written informed consent (parent or guardian must sign when applicable) and assent form, if required;
- Evidence of eosinophilic esophagitis defined by esophageal mucosal eosinophil count greater than or equal to 24 per HPF (400x magnification) in at least 1 of the esophageal sites biopsied (proximal/middle and/or distal);
- Lack of histological response to previously administered high dose proton pump inhibitor;
- Clinical symptoms of eosinophilic esophagitis with at least one of the following symptoms: chest pain or discomfort, dysphagia (difficulty swallowing) or food impaction.
Key exclusion criteria (15 listed)
- Known contraindication, hypersensitivity or intolerance to corticosteroids;
- Any physical, mental, or social condition, history of illness or laboratory abnormality that, in the investigator's judgment, might interfere with study procedures or the ability of the subject to adhere to and complete the study;
- Oral or esophageal mucosal infection of any type;
- Any condition affecting the esophageal mucosa or altering esophageal motility other than EoE;
- Use of systemic (oral or parenteral) or inhaled, intranasal or high-potency dermal topical corticosteroids in the 30 days prior to the esophageal biopsy required for entrance to this study (or prior to EGD if done during the pre-Screening period) or at any time between the biopsy and the Randomization Visit;
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 |
|---|---|---|
| EUR-1100Active oral medication | Drug | EUR-1100 1.5 mg, EUR-1100 3.0 mg |
| placebomatching placebo | Drug | placebo |
Primary outcome
Morning serum cortisol (change from baseline measure)
Time frame: Screening visit (up to 21 days), week 4, week 8 and follow-up
Standard safety laboratory tests
Time frame: Screening visit (up to 21 days), week 4, week 8 and follow-up
Hematology, serum chemistry and liver function tests, urinalysis, urine chemistry
Treatment-emergent adverse events collection
Time frame: Screening visit (up to 21 days), Randomization day, week 2 and week 6(phone visit), week 4 and week 8 (office visit), follow-up (office visit, up to 11 days after week 8 visit)
Physical examination and vital signs collection
Time frame: Screening (up to 21 days), week4, week 8 and follow-up
2 secondary outcomes
Esophagoduodenoscopy with multiple biopsies
Time frame: Screening (up to 21 days) and week 8
Patient reported outcomes, and physician global assessment
Time frame: Screening (up to 21 days), week 4 and 8.
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 2 Nov 2012.
- Derived from this study: PubMed 30476587Schoepfer AM, Hirano I, Coslovsky M, Roumet MC, Zwahlen M, Kuehni CE, Hafner D, Alexander JA, Dellon ES, Gonsalves N, Leung J, Bussmann C, Collins MH, Newbury RO, Smyrk TC, Woosley JT, Yang GY, Romero Y, Katzka DA, Furuta GT, Gupta SK, Aceves SS, Chehade M, Spergel JM, Falk GW, Meltzer BA, Comer GM, Straumann A, Safroneeva E; International EEsAI Study Group. Variation in Endoscopic Activity Assessment and Endoscopy Score Validation in Adults With Eosinophilic Esophagitis. Clin Gastroenterol Hepatol. 2019 Jul;17(8):1477-1488.e10. doi: 10.1016/j.cgh.2018.11.032. Epub 2018 Nov 23.
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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.
Ikuo Hirano, MD principal investigator
Northwestern University School of Medicine
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing EUR-1100 in people with Eosinophilic Esophagitis, run by Forest Laboratories at 7 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 5 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: finished, as of the sponsor's last update on 2 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 combined 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.
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?
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?
Morning serum cortisol (change from baseline measure) (time frame: Screening visit (up to 21 days), week 4, week 8 and follow-up). The study lists 4 primary outcomes in all. 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 NCT01386112, 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 2 Nov 2012.