Assessing the Efficacy of Steroid Treatment of Achalasia
This study is enrolling participants by invitation only.
Information provided by (Responsible Party):
Karthik Ravi, M.D., Mayo Clinic
First received: July 16, 2013
Last updated: NA
Last verified: July 2013
History: No changes posted
Would systemic steroids be an effective treatment in early variants of achalasia?
|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:
U.S. FDA Resources
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 ]
|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)|
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.
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