Reduction in Symptomatic Esophageal Stricture Formation
|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.
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|