Status:
WITHDRAWN
Assessing the Efficacy of Steroid Treatment of Achalasia
Lead Sponsor:
Mayo Clinic
Conditions:
Achalasia
Eligibility:
All Genders
18-90 years
Phase:
PHASE4
Brief Summary
Would systemic steroids be an effective treatment in early variants of achalasia?
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Adults ages 18-90 with a diagnosis of achalasia confirmed by findings on esophageal manometry and barium esophagogram will be eligible for the study.
- Eckardt score6 greater or equal to 6 or 2 or greater for dysphagia and/or regurgitation
- Symptoms less than 2 years
- Exclusion criteria:
- Medical conditions such as severe heart or lung disease that preclude safe performance of endoscopy and injection;
- 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.
Exclusion
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 28 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01903486
Start Date
March 1 2013
End Date
December 28 2020
Last Update
November 17 2021
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