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Assessing the Efficacy of Steroid Treatment of Achalasia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01903486
Recruitment Status : Enrolling by invitation
First Posted : July 19, 2013
Last Update Posted : December 10, 2019
Information provided by (Responsible Party):
Karthik Ravi, M.D., Mayo Clinic

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

Condition or disease Intervention/treatment Phase
Achalasia Drug: Apo-Prednisone Cordorol, Detasone - Prednisone Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study Assessing the Efficacy of Steroids in the Treatment of Achalasia
Study Start Date : March 2013
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids
Drug Information available for: Prednisone

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. the proportion of patients with an Eckhart score ≥ 6 at 1 month [ Time Frame: Baseline to 1 month ]

Secondary Outcome Measures :
  1. proportion of patients with symptomatic improvement (Eckardt sore 6 or greater) [ Time Frame: baseline to 1 year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01903486

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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
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Principal Investigator: Karthik Ravi, MD Mayo Clinic
Additional Information:
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Responsible Party: Karthik Ravi, M.D., PI, Mayo Clinic Identifier: NCT01903486    
Other Study ID Numbers: 12-009825
First Posted: July 19, 2013    Key Record Dates
Last Update Posted: December 10, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Karthik Ravi, M.D., Mayo Clinic:
Trouble swallowing
disorder of the esophagus
Additional relevant MeSH terms:
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Esophageal Achalasia
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents