Assessing the Efficacy of Steroid Treatment of Achalasia

Mayo Clinic

Status and phase: Withdrawn; Phase 4

Conditions: Achalasia

Treatments: Drug: Apo-Prednisone Cordorol, Detasone - Prednisone

Study type: Interventional

Funder types: Other

Identifiers

NCT01903486

12-009825

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 90 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

0 participants in 1 patient group

Prednisone

Other group

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.

Treatment:

Drug: Apo-Prednisone Cordorol, Detasone - Prednisone