Assessing the Efficacy of Steroid Treatment of Achalasia

NCT01903486 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 12-009825
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Achalasia

Keywords

Trouble swallowing; dysphagia; disorder of the esophagus

Outcome Measures

Primary Outcomes (1)

• the proportion of patients with an Eckhart score ≥ 6 at 1 month

  Baseline to 1 month

Secondary Outcomes (1)

• proportion of patients with symptomatic improvement (Eckardt sore 6 or greater)

  baseline to 1 year

Study Arms (1)

Prednisone

OTHER

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

Interventions

Apo-Prednisone Cordorol, Detasone - Prednisone DRUG

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.

Also known as: Prednisone, Anti-inflamatory, Corticosteroid

Prednisone

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Esophageal Achalasia; Deglutition Disorders

Interventions

Prednisone; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Karthik Ravi, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: July 16, 2013
• First Posted: July 19, 2013
• Study Start: March 1, 2013
• Primary Completion: December 28, 2020
• Study Completion: December 28, 2020
• Last Updated: November 17, 2021

Record last verified: 2021-11