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Inadequate recruitment
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| Name | Class |
|---|---|
| TAP Pharmaceutical Products Inc. | INDUSTRY |
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Background: Up to 40% of patients who are treated with PPIs for symptoms that are thought to be due to GERD experience only incomplete relief of their symptoms. Those patients are deemed "PPI failures." Esophageal pH monitoring studies have shown that PPI failure rarely is due to persistent acid reflux. Recently, heartburn that is refractory to treatment with PPIs has been described in patients with eosinophilic esophagitis, a disorder of unknown etiology in which eosinophils infiltrate the squamous epithelium of the esophagus, where they cause symptoms and tissue injury. Presently, it is not clear how often eosinophilic esophagitis underlies PPI failure for patients with GERD symptoms.
Purpose: To estimate the frequency with which eosinophilic esophagitis is the cause of "PPI failure" in patients thought to have heartburn due to GERD.
Methods: Patients referred to the Division of Gastroenterology at the Dallas VA Medical Center for the evaluation of heartburn that is refractory to PPI therapy will be invited to participate in the study. Patients who provide informed consent will have a medical history taken. Women of child bearing potential will have a pregnancy test. The patients' current PPI therapy will be discontinued, and patients will be treated with lansoprazole 30 mg BID for one week. The patient will return to the clinic one week later. Patients who feel that their heartburn has not improved by more than 50% from baseline will have an endoscopic evaluation. During the endoscopic examination, biopsy specimens will be taken as follows: A. Two specimens from the proximal esophagus at 20 cm from the incisor teeth. B. Two specimens from the mid-esophagus at 28 cm from the incisor teeth. C. Two specimens from the distal esophagus, 3 cm above the squamo-columnar junction. D. Two specimens from the distal esophagus, 1 cm above the squamo-columnar junction. E. Two specimens from the second portion of the duodenum (to see if the eosinophilia is confined to the esophagus, or part of a more extensive eosinophilic gastroenteritis). A diagnosis of eosinophilic esophagitis will be made if there is at least one high-power field with >25 eosinophils, or two or more high-power fields with >15 eosinophils.
Potential Benefits: This study will provide an estimate on the frequency with which eosinophilic esophagitis is the cause of "PPI failure" in patients thought to have heartburn due to GERD. This has substantial potential importance for patient management.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treat with lansoprazole 30 mg BID for 2 weeks, endoscopic examination with esophageal biopsy for patients with persistent symptoms | Drug | Treat with lansoprazole 30 mg BID for 2 weeks, perform endoscopic examination with esophageal biopsy |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Eosinophilic Esophagitis | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Who Had Resolution of Heartburn With Lansoprazole | Resolution of heartburn defined as >50% improvement in symptoms | After 8 weeks of treatment |
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Inclusion Criteria:Male and female patients ages 18 years and older who are referred to the Division of Gastroenterology at the Dallas VA Medical Center for the evaluation of heartburn that is refractory to PPI therapy
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stuart J Spechler, MD | Dallas VA Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dallas VA Medical Center | Dallas | Texas | 75216 | United States |
102 patients agreed to participate. For 10 patients the symptom described was not consistent with heartburn and another 27 described heartburn that was not refractory to therapy. 65 patient had PPI-resistant heartburn; 33 were taking PPI incorrectly; 11 taking insufficient dose of omeprazole.
Consecutive patients referred to a general GI clinic at our VA hospital for the evaluation of PPI-resistant heartburn were invited to participate.
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients Whose PPI Was Changed to Lansoprazole | In 21 patients taking omeprazole ≥80 mg/day, the PPI was changed to lansoprazole 30 mg BID before breakfast and dinner. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients Whose PPI Was Changed to Lansoprazole | In 21 patients taking omeprazole ≥80 mg/day, the PPI was changed to lansoprazole 30 mg BID before breakfast and dinner. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Number of Participants With Eosinophilic Esophagitis | Posted | Number | participants | 8 weeks |
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| Secondary | Number of Patients Who Had Resolution of Heartburn With Lansoprazole | Resolution of heartburn defined as >50% improvement in symptoms | Posted | Number | participants | After 8 weeks of treatment |
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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 | Patients Whose PPI Was Changed to Lansoprazole | In 21 patients taking omeprazole ≥80 mg/day, the PPI was changed to lansoprazole 30 mg BID before breakfast and dinner. | 0 | 21 | 0 | 21 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stuart Spechler | Dallas VAMC | 214-374-7799 | sjspechler@aol.com |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D057765 | Eosinophilic Esophagitis |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D004941 | Esophagitis |
| D005759 | Gastroenteritis |
| D004802 | Eosinophilia |
| D007960 | Leukocyte Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D003033 | Coal Tar |
| D064747 | Lansoprazole |
| C494814 | BID protein, human |
| D004724 | Endoscopy |
| ID | Term |
|---|---|
| D013638 | Tars |
| D045424 | Complex Mixtures |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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