The Frequency of Eosinophilic Esophagitis in Patients With Heartburn That is Refractory to Proton Pump Inhibitors

This study has been terminated.

(Inadequate recruitment)

Sponsor:

Collaborator:

TAP Pharmaceutical Products Inc.

Information provided by (Responsible Party):

Stuart Spechler, Dallas VA Medical Center

ClinicalTrials.gov Identifier:

NCT01404832

First received: July 27, 2011

Last updated: February 26, 2013

Last verified: February 2013

History of Changes

Results First Received: February 26, 2013

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Diagnostic
Conditions:	Gastroesophageal Reflux Disease Eosinophilic Esophagitis
Intervention:	Drug: Treat with lansoprazole 30 mg BID for 2 weeks, endoscopic examination with esophageal biopsy for patients with persistent symptoms

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Consecutive patients referred to a general GI clinic at our VA hospital for the evaluation of PPI-resistant heartburn were invited to participate.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups

	Description
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.

Participant Flow: Overall Study

	Patients Whose PPI Was Changed to Lansoprazole
STARTED	21
COMPLETED	21
NOT COMPLETED	0

Baseline Characteristics

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Reporting Groups

	Description
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.

Baseline Measures

	Patients Whose PPI Was Changed to Lansoprazole
Number of Participants [units: participants]	21
Age [units: participants]
<=18 years	0
Between 18 and 65 years	17
>=65 years	4
Gender [units: participants]
Female	3
Male	18
Region of Enrollment [units: participants]
United States	21

Outcome Measures

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1. Primary:

Number of Participants With Eosinophilic Esophagitis [ Time Frame: 8 weeks ]

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2. Secondary:

Number of Patients Who Had Resolution of Heartburn With Lansoprazole [ Time Frame: After 8 weeks of treatment ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Stuart Spechler
Organization: Dallas VAMC
phone: 214-374-7799
e-mail: sjspechler@aol.com

No publications provided

Responsible Party:	Stuart Spechler, Dallas VA Medical Center
ClinicalTrials.gov Identifier:	NCT01404832 History of Changes
Other Study ID Numbers:	VAIRB06-093
Study First Received:	July 27, 2011
Results First Received:	February 26, 2013
Last Updated:	February 26, 2013
Health Authority:	United States: Food and Drug Administration

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