Reduction in Symptomatic Esophageal Stricture Formation
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|ClinicalTrials.gov Identifier: NCT02039115|
Recruitment Status : Terminated (Closed for low enrollment and the inability to complete the study.)
First Posted : January 17, 2014
Results First Posted : September 8, 2017
Last Update Posted : September 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Stenosis||Drug: prednisone Drug: placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Reduction in Symptomatic Esophageal Stricture Formation Post-two Stage Complete Barrett's Excision for High Grade Dysplasia or Early Adenocarcinoma With Short-term Steroid Therapy: A Randomized, Double-blinded, Placebo-controlled, Multicenter Trial.|
|Study Start Date :||March 2014|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||February 2015|
Daily oral prednisone is taken for 6 weeks, at a dose of 40mg/day in week 1, 30mg/day in week 2, 20mg/day week 3 and 4, 10mg/day in week 5, and 5mg/day in week 6. Prednisone is taken in the morning. Treatment commences the day of the procedure, with the dose taken with a sip of water prior to discharge. The 6-week treatment regimen is given after both the 1st and 2nd stage complete Barretts excision.
6 weeks of prednisone and placebo therapy will be given over 6 weeks after both the first and second stage complete Barretts Excision.
Other Name: steroid
Placebo Comparator: placebo
Placebo tablets will be taken in the same manner as the prednisone arm.
6 weeks of placebo therapy will be given in the same manner as the prednisone arm after the first and second stage complete Barretts excision.
Other Name: control
- Stricture Formation [ Time Frame: 98 weeks ]Primary outcome measure is the rate of symptomatic esophageal stricture formation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02039115
|United States, Florida|
|Orlando, Florida, United States, 32803|
|Principal Investigator:||Robert Hawes Hawes, MD||Florida Hospital|