Trial Outcomes & Findings for The Frequency of Eosinophilic Esophagitis in Patients With Heartburn That is Refractory to Proton Pump Inhibitors (NCT NCT01404832)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

102 participants

Primary outcome timeframe

8 weeks

Results posted on

2013-02-27

Participant Flow

Consecutive patients referred to a general GI clinic at our VA hospital for the evaluation of PPI-resistant heartburn were invited to participate.

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	21
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients Whose PPI Was Changed to Lansoprazole n=21 Participants In 21 patients taking omeprazole ≥80 mg/day, the PPI was changed to lansoprazole 30 mg BID before breakfast and dinner.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Outcome measures

Outcome measures
Measure	Patients Whose PPI Was Changed to Lansoprazole n=21 Participants In 21 patients taking omeprazole ≥80 mg/day, the PPI was changed to lansoprazole 30 mg BID before breakfast and dinner.
Number of Participants With Eosinophilic Esophagitis	0 participants

SECONDARY outcome

Timeframe: After 8 weeks of treatment

Resolution of heartburn defined as \>50% improvement in symptoms

Outcome measures

Outcome measures
Measure	Patients Whose PPI Was Changed to Lansoprazole n=21 Participants In 21 patients taking omeprazole ≥80 mg/day, the PPI was changed to lansoprazole 30 mg BID before breakfast and dinner.
Number of Patients Who Had Resolution of Heartburn With Lansoprazole	9 participants

Adverse Events

Patients Whose PPI Was Changed to Lansoprazole

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Stuart Spechler

Dallas VAMC

Phone: 214-374-7799

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place