Assessing the Efficacy of Steroid Treatment of Achalasia

November 10, 2021 updated by: Karthik Ravi, M.D., Mayo Clinic

A Pilot Study Assessing the Efficacy of Steroids in the Treatment of Achalasia

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
  • Corticosteroid
  • Anti-inflamatory

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the proportion of patients with an Eckhart score ≥ 6 at 1 month
Time Frame: Baseline to 1 month
Baseline to 1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
proportion of patients with symptomatic improvement (Eckardt sore 6 or greater)
Time Frame: baseline to 1 year
baseline to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

December 28, 2020

Study Completion (Actual)

December 28, 2020

Study Registration Dates

First Submitted

July 16, 2013

First Submitted That Met QC Criteria

July 16, 2013

First Posted (Estimate)

July 19, 2013

Study Record Updates

Last Update Posted (Actual)

November 17, 2021

Last Update Submitted That Met QC Criteria

November 10, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-009825

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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