Assessing the Efficacy of Steroid Treatment of Achalasia

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Karthik Ravi, M.D., Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01903486
First received: July 16, 2013
Last updated: NA
Last verified: July 2013
History: No changes posted
  Purpose

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


Condition Intervention Phase
Achalasia
Drug: Apo-Prednisone Cordorol, Detasone - Prednisone
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study Assessing the Efficacy of Steroids in the Treatment of Achalasia

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • the proportion of patients with an Eckhart score ≥ 6 at 1 month [ Time Frame: Baseline to 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • proportion of patients with symptomatic improvement (Eckardt sore 6 or greater) [ Time Frame: baseline to 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: March 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01903486

Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Karthik Ravi, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Karthik Ravi, M.D., PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01903486     History of Changes
Other Study ID Numbers: 12-009825
Study First Received: July 16, 2013
Last Updated: July 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Trouble swallowing
dysphagia
disorder of the esophagus

Additional relevant MeSH terms:
Esophageal Achalasia
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Prednisone
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 23, 2014