Assessing the Efficacy of Steroid Treatment of Achalasia

Achalasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01903486
• Other study ID #: 12-009825
• Status: Withdrawn
• Phase: Phase 4
• Start date: March 2013
• Est. completion date: December 28, 2020

Study information

• Verified date: November 2021
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 28, 2020
• Est. primary completion date: December 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Achalasia
• Esophageal Achalasia

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the proportion of patients with an Eckhart score = 6 at 1 month		Baseline to 1 month
Secondary	proportion of patients with symptomatic improvement (Eckardt sore 6 or greater)		baseline to 1 year

External Links

•   Mayo Clinic Clinical Trials