Eosinophilic Esophagitis (EoE)Phase 2NCT02058537
Bethanechol for Eosinophilic Esophagitis
A Phase 2 study testing Bethanechol in people with Eosinophilic Esophagitis (EoE), run by University of Iowa at 1 site in United States.
Trial summary
The primary goals of this study are to ease the symptoms of patients with Eosinophilic Esophagitis (EoE) and to test the effectiveness of the drug bethanechol in relieving those symptoms. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Eosinophilic Esophagitis (EoE)
- What is being tested?
- Bethanechol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Jul 2014
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female
- Age 18-75
- Symptoms associated with EoE such as dysphagia, heartburn, vomiting, abdominal pain, food impaction
- Subject has signed informed consent for the administration of bethanechol that informs the patient of potential adverse events
- Clinically or pathologically proven EoE
Who cannot join
- Known allergy to bethanechol
- Asthma
- Pregnant or breast-feeding women
- Severe neurological problems
- Severe diabetes
- Achalasia
Show all 22Show fewer
- Known allergy to lidocaine or other local anesthetic
- Hypothyroidism
- Peptic ulcer
- Pronounced bradycardia or hypotension
- Vasomotor instability
- Coronary artery disease
- Epilepsy
- Parkinsonism
- Weakened gastrointestinal or bladder wall
- Mechanical obstruction of the gastrointestinal tract or bladder neck
- Urinary bladder surgery in the 6 months prior to the study
- Gastrointestinal resection and anastomosis
- Spastic gastrointestinal disturbances
- Acute inflammatory lesions of the gastrointestinal tract
- Peritonitis
- Marked vagotonia
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
About this study
Official title: Bethanechol for Treatment of Eosinophilic Esophagitis (EoE)
The primary goals of this study are to ease the symptoms of patients with Eosinophilic Esophagitis (EoE) and to test the effectiveness of the drug bethanechol in relieving those symptoms.
- Conditions
- Eosinophilic Esophagitis (EoE)
- Being tested
- Bethanechol
- Medical subject headings
- Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BethanecholDrug
Due to the fact that this study has only 1 arm and all study subjects will receive the study drug in the same manner and dose, there are no other details to cover.
| Study group | Role | What they receive |
|---|---|---|
| Bethanechol | Experimental | Oral administration of 25 milligrams of bethanechol taken twice daily for a minimum of 7 days. Total dose taken daily for a minimum of 7 days is 50 mg. Receives: Drug: Bethanechol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline High Resolution Esophageal Manometry With Impedance to Day 7
The high resolution esophageal manometry with impedance involves a thin, pressure-sensitive tube that is passed through the nose and into the stomach. Once in place, the tube is pulled slowly back into the esophagus (food pipe). When the tube is in the esophagus, the patient is asked to swallow several times while swallowing water, applesauce, crackers, and marshmallows. These swallows will be completed while laying down, sitting upright, and standing. The pressure of the muscle contractions will be measured along several sections of the tube. The tube is removed after the tests are completed. This test allows for a quantitative measure of the pressure in the esophagus that can be correlated to difficulty or ease of bolus swallowing.
Measured: Day 1 and Day 7
Secondary outcomes (1)
Change From Baseline Evaluation of Esophageal Function Questionnaire to Day 7
This questionnaire allows the patient to assess their own symptoms and report their opinions about drug effectiveness.
Measured: Day 1 and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionJul 2014
- Study completionJul 2014
Why it stopped: Initial PI left, study not continued
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.
- Other trials for Eosinophilic Esophagitis (EoE)Studies of the same condition, open and under way.
- More trials run by University of IowaThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Assouline-Dayan, Yehudith, University of Iowa
- Investigators
- Yehudith Assouline-Dayan, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02058537
- Sponsor's protocol ID
- Bethanechol
- Status last verified
- Mar 2016
- First submitted
- 4 Feb 2014
- Last updated
- 22 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bethanechol for Treatment of Eosinophilic Esophagitis (EoE)
- ClinicalTrials.gov ID
- NCT02058537
- Acronym / sponsor ID
- Bethanechol
- Conditions
- Eosinophilic Esophagitis (EoE)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Initial PI left, study not continued
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 10 Feb 2014 (estimated)
- Results
- Posted 22 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary goals of this study are to ease the symptoms of patients with Eosinophilic Esophagitis (EoE) and to test the effectiveness of the drug bethanechol in relieving those symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bethanechol | Experimental | Drug: BethanecholOral administration of 25 milligrams of bethanechol taken twice daily for a minimum of 7 days. Total dose taken daily for a minimum of 7 days is 50 mg. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or Female
- Age 18-75
- Symptoms associated with EoE such as dysphagia, heartburn, vomiting, abdominal pain, food impaction
- Subject has signed informed consent for the administration of bethanechol that informs the patient of potential adverse events
- Clinically or pathologically proven EoE
Key exclusion criteria (22 listed)
- Known allergy to bethanechol
- Asthma
- Pregnant or breast-feeding women
- Severe neurological problems
- Severe diabetes
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 |
|---|---|---|
| BethanecholDue to the fact that this study has only 1 arm and all study subjects will receive the study drug in the same manner and dose, there are no other details to cover. | Drug | Bethanechol |
Primary outcome
Change From Baseline High Resolution Esophageal Manometry With Impedance to Day 7
Time frame: Day 1 and Day 7
The high resolution esophageal manometry with impedance involves a thin, pressure-sensitive tube that is passed through the nose and into the stomach. Once in place, the tube is pulled slowly back into the esophagus (food pipe). When the tube is in the esophagus, the patient is asked to swallow several times while swallowing water, applesauce, crackers, and marshmallows. These swallows will be completed while laying down, sitting upright, and standing. The pressure of the muscle contractions will be measured along several sections of the tube. The tube is removed after the tests are completed. This test allows for a quantitative measure of the pressure in the esophagus that can be correlated to difficulty or ease of bolus swallowing.
1 secondary outcome
Change From Baseline Evaluation of Esophageal Function Questionnaire to Day 7
Time frame: Day 1 and Day 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Yehudith Assouline-Dayan, MD principal investigator
University of Iowa
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 Bethanechol in people with Eosinophilic Esophagitis (EoE), run by University of Iowa 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 5 inclusion and 22 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 22 Apr 2016. 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. 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 22 Apr 2016). 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?
Change From Baseline High Resolution Esophageal Manometry With Impedance to Day 7 (time frame: Day 1 and Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2016.