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Closed for low enrollment and the inability to complete the study.
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Complete endoscopic resection of early neoplastic Barrett's Esophagus (BE) is a curative procedure. However, a significant proportion of patients develop symptomatic esophageal strictures following Complete Barrett's Eradication (CBE), and this limits the technique, particularly for circumferential and longer segment disease. Oral steroid therapy may reduce stricture formation; thereby allowing CBE to be performed with minimal associated morbidity.
The main objective of the proposed randomized trial is to compare the rate of symptomatic oesophageal strictures in patients receiving placebo versus oral prednisone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| prednisone | Experimental | 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. |
|
| placebo | Placebo Comparator | Placebo tablets will be taken in the same manner as the prednisone arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prednisone | Drug | 6 weeks of prednisone and placebo therapy will be given over 6 weeks after both the first and second stage complete Barretts Excision. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stricture Formation | Primary outcome measure is the rate of symptomatic esophageal stricture formation. | 98 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Hawes Hawes, MD | AdventHealth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Hospital | Orlando | Florida | 32803 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Prednisone | 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. prednisone: 6 weeks of prednisone and placebo therapy will be given over 6 weeks after both the first and second stage complete Barretts Excision. |
| FG001 | Placebo | Placebo tablets will be taken in the same manner as the prednisone arm. placebo: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Prednisone | 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. prednisone: 6 weeks of prednisone and placebo therapy will be given over 6 weeks after both the first and second stage complete Barretts Excision. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Stricture Formation | Primary outcome measure is the rate of symptomatic esophageal stricture formation. | Posted | Count of Participants | Participants | 98 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prednisone | 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. prednisone: 6 weeks of prednisone and placebo therapy will be given over 6 weeks after both the first and second stage complete Barretts Excision. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robin (Barron-Nelson) Kangas | Center for Interventional Endoscopy | 407.303.5503 | Robin.Barron@flhosp.org |
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| ID | Term |
|---|---|
| D004940 | Esophageal Stenosis |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D011241 | Prednisone |
| D013256 | Steroids |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D000072473 | Fused-Ring Compounds |
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| placebo | Drug | 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. |
|
|
| BG001 | Placebo | Placebo tablets will be taken in the same manner as the prednisone arm. placebo: 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Placebo tablets will be taken in the same manner as the prednisone arm. placebo: 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. |
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| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Placebo | Placebo tablets will be taken in the same manner as the prednisone arm. placebo: 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D011083 |
| Polycyclic Compounds |