Assessing the Efficacy of Steroid Treatment of Achalasia
NCT ID: NCT01903486
Last Updated: 2021-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2013-03-31
2020-12-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Prednisone
Prednisone (study medication) at a dose of 40mg for 1 week, then 30mg for 1 week, then 20mg for 1 week, then 10mg for 1 week, and then stop the medication.
Apo-Prednisone Cordorol, Detasone - Prednisone
Oral prednisone (study medication) at a dose of 40mg for 1 week, then 30mg for 1 week, then 20mg for 1 week, then 10mg for 1 week, and then stop the medication.
Interventions
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Apo-Prednisone Cordorol, Detasone - Prednisone
Oral prednisone (study medication) at a dose of 40mg for 1 week, then 30mg for 1 week, then 20mg for 1 week, then 10mg for 1 week, and then stop the medication.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eckardt score6 greater or equal to 6 or 2 or greater for dysphagia and/or regurgitation
* Symptoms less than 2 years
Exclusion Criteria
* Greater than mild esophageal dilation
* Type 1 achalasia as defined by the Chicago classification scheme7 and/or esophageal diameter \> 3cm;
* Prior treatment for achalasia
* Use of medications that might affect LES pressure such as anticholinergics or calcium channel antagonists
* Symptom duration greater than 2 years
* Inability to read due to: Blindness, cognitive dysfunction, or English language illiteracy
* Disorders which predispose to unreliable responses such as Schizophrenia, Alzheimer's disease or significant memory loss
* Pregnant and lactating females will be excluded as steroids are not thought safe for the fetus.
18 Years
90 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Karthik Ravi, M.D.
PI
Principal Investigators
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Karthik Ravi, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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12-009825
Identifier Type: -
Identifier Source: org_study_id