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Assessing the Efficacy of Steroid Treatment of Achalasia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01903486
Recruitment Status : Enrolling by invitation
First Posted : July 19, 2013
Last Update Posted : November 12, 2018
Sponsor:
Information provided by (Responsible Party):
Karthik Ravi, M.D., Mayo Clinic

Tracking Information
First Submitted Date  ICMJE July 16, 2013
First Posted Date  ICMJE July 19, 2013
Last Update Posted Date November 12, 2018
Study Start Date  ICMJE March 2013
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2013)
the proportion of patients with an Eckhart score ≥ 6 at 1 month [ Time Frame: Baseline to 1 month ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01903486 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2013)
proportion of patients with symptomatic improvement (Eckardt sore 6 or greater) [ Time Frame: baseline to 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessing the Efficacy of Steroid Treatment of Achalasia
Official Title  ICMJE A Pilot Study Assessing the Efficacy of Steroids in the Treatment of Achalasia
Brief Summary Would systemic steroids be an effective treatment in early variants of achalasia?
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Achalasia
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Drug: Apo-Prednisone Cordorol, Detasone - Prednisone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: July 16, 2013)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01903486
Other Study ID Numbers  ICMJE 12-009825
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Karthik Ravi, M.D., Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Karthik Ravi, MD Mayo Clinic
PRS Account Mayo Clinic
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP