Back to resultsAssessing the Efficacy of Steroid Treatment of Achalasia
Primary Purpose
Achalasia
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Apo-Prednisone Cordorol, Detasone - Prednisone
Sponsored by
About this trial
This is an interventional treatment trial for Achalasia focused on measuring Trouble swallowing, dysphagia, disorder of the esophagus
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Prednisone
Arm Description
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.
Outcomes
Primary Outcome Measures
the proportion of patients with an Eckhart score ≥ 6 at 1 month
Secondary Outcome Measures
proportion of patients with symptomatic improvement (Eckardt sore 6 or greater)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01903486
Brief Title
Assessing the Efficacy of Steroid Treatment of Achalasia
Official Title
A Pilot Study Assessing the Efficacy of Steroids in the Treatment of Achalasia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Unable to recruit participants.
Study Start Date
March 2013 (undefined)
Primary Completion Date
December 28, 2020 (Actual)
Study Completion Date
December 28, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Would systemic steroids be an effective treatment in early variants of achalasia?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achalasia
Keywords
Trouble swallowing, dysphagia, disorder of the esophagus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prednisone
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Apo-Prednisone Cordorol, Detasone - Prednisone
Other Intervention Name(s)
Prednisone, Anti-inflamatory, Corticosteroid
Intervention Description
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.
Primary Outcome Measure Information:
Title
the proportion of patients with an Eckhart score ≥ 6 at 1 month
Time Frame
Baseline to 1 month
Secondary Outcome Measure Information:
Title
proportion of patients with symptomatic improvement (Eckardt sore 6 or greater)
Time Frame
baseline to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karthik Ravi, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Assessing the Efficacy of Steroid Treatment of Achalasia
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