Assessing the Efficacy of Steroid Treatment of Achalasia

Sponsor

Mayo Clinic (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01903486

Collaborator

(none)

Enrollment

Arm

93.9

Duration (Months)

Study Details

Study Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

0 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 :

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

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

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

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.