Assessing the Efficacy of Steroid Treatment of Achalasia

Mayo Clinic (Other)
Overall Status
Withdrawn ID

Study Details

Study Description

Brief Summary

Would systemic steroids be an effective treatment in early variants of achalasia?

Condition or Disease Intervention/Treatment Phase
  • Drug: Apo-Prednisone Cordorol, Detasone - Prednisone
Phase 4

Study Design

Study Type:
Actual Enrollment :
0 participants
Intervention Model:
Single Group Assignment
None (Open Label)
Primary Purpose:
Official Title:
A Pilot Study Assessing the Efficacy of Steroids in the Treatment of Achalasia
Study Start Date :
Mar 1, 2013
Actual Primary Completion Date :
Dec 28, 2020
Actual Study Completion Date :
Dec 28, 2020

Arms and Interventions

Arm Intervention/Treatment
Other: 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.

Drug: 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 Names:
  • Prednisone
  • Anti-inflamatory
  • Corticosteroid
  • Outcome Measures

    Primary Outcome Measures

    1. the proportion of patients with an Eckhart score ≥ 6 at 1 month [Baseline to 1 month]

    Secondary Outcome Measures

    1. proportion of patients with symptomatic improvement (Eckardt sore 6 or greater) [baseline to 1 year]

    Eligibility Criteria


    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    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.

    Contacts and Locations


    No locations specified.

    Sponsors and Collaborators

    • Mayo Clinic


    • Principal Investigator: Karthik Ravi, MD, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:


    None provided.
    Responsible Party:
    Karthik Ravi, M.D., PI, Mayo Clinic Identifier:
    Other Study ID Numbers:
    • 12-009825
    First Posted:
    Jul 19, 2013
    Last Update Posted:
    Nov 17, 2021
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Studies a U.S. FDA-regulated Device Product:
    Keywords provided by Karthik Ravi, M.D., PI, Mayo Clinic
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 17, 2021