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Secretrol administered over a 6 month period to patients with Barrett's Esophagus will be safe and well tolerated. Further, pH control will be evaluated in the distal esophageal mucosa and just below the squamocolumnar junction.
A majority of patients with Barrett's esophagus have poor distal esophageal pH control. Such patients frequently receive more than one dose of PPI per day in an attempt to improve esophageal pH control. Nocturnal pH control is notably difficult to achieve in many patients suffering from Barrett's esophagus. Recently, adverse effects have been associated with prolonged PPI use (defined as 1 year or longer). These include hypomagnesemia, bone fractures, Clostridium difficile induced diarrhea. High dose PPI as well as very high dose PPI usage (such as that used in hypersecretory conditions) has generally not been found to produce a different side effect or tolerability profile in humans. This study will evaluate the effects of Secretrol on tolerability, adverse effects and pH control of the distal esophagus and just below the squamocolumnar junction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Secretrol | Experimental | Secretrol Capsules 80/80 once daily for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Secretrol | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with adverse events | at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who develop C. difficile induced diarrhea | Over 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Gastrin 17 | Serum Gastrin 17 will be measured and compared to baseline. | Baseline, Day 30, 6 months |
| Bile acids/salts | Bile acids and bile salts can be affected by pH changes. The differential characterization of bile acid and bile salts will be performed at Baseline as compared to Day 30 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prateek Sharma, M.D. | Kansas City, Missouri VAMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veteran's Administration Medical Center | Kansas City | Missouri | 64128 | United States |
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| ID | Term |
|---|---|
| D001471 | Barrett Esophagus |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| Baseline, Day 30 |
| Serum calcium | Baseline, 30 days and 6 months |
| Serum magnesium | Baseline, 30 days and 6 months |
| 48 hour gastroesophageal pH measurement | Baseline, 30 days |
| D004066 |
| Digestive System Diseases |