Trial Outcomes & Findings for Assessment of Zegerid on Esophageal pH in Patients With Barrett's Esophagus (NCT NCT01129778)

Results Overview

Reported as the the average percentage over 24 hours of total time, upright time, and supine time per day with pH \<4 (symptomatic acid state) as evaluated with the Bravo pH monitoring technique.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

27 participants

Primary outcome timeframe

Days 1 and 2

Results posted on

2017-06-06

Participant Flow

5 participants withdrew after providing their informed consent and before beginning their participation in the study.

Participant milestones

Participant milestones
Measure	Received Zegerid (Ome-NaBic) Ome-NaBic 40 mg orally 1 h before breakfast and bedtime for up to 29 days
Overall Study STARTED	22
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Assessment of Zegerid on Esophageal pH in Patients With Barrett's Esophagus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Received Zegerid (Ome-NaBic) n=21 Participants Ome-NaBic 40 mg orally 1 h before breakfast and bedtime for up to 29 days
Age, Continuous	61 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Mean RDQ heartburn score	10 units on a scale STANDARD_DEVIATION 6 • n=5 Participants

PRIMARY outcome

Timeframe: Days 1 and 2

Population: Participants who completed all protocol-specified assessments were included in the analysis.

Reported as the the average percentage over 24 hours of total time, upright time, and supine time per day with pH \<4 (symptomatic acid state) as evaluated with the Bravo pH monitoring technique.

Outcome measures

Outcome measures
Measure	Received Zegerid (Ome-NaBic) n=15 Participants Ome-NaBic 40 mg orally 1 h before breakfast and bedtime for up to 29 days
Percentage of Time Esophageal pH< 4 Total time pH <4 First Day	0.4 percentage of hours Standard Deviation 0.5
Percentage of Time Esophageal pH< 4 Total time pH <4 Second Day	0.6 percentage of hours Standard Deviation 1.8
Percentage of Time Esophageal pH< 4 Upright time pH <4 First Day	0.7 percentage of hours Standard Deviation 0.7
Percentage of Time Esophageal pH< 4 Upright time pH <4 Second Day	1 percentage of hours Standard Deviation 3
Percentage of Time Esophageal pH< 4 Supine time pH <4 First Day	0.06 percentage of hours Standard Deviation 0.1
Percentage of Time Esophageal pH< 4 Supine time pH <4 Second Day	0.05 percentage of hours Standard Deviation 0.2

SECONDARY outcome

Timeframe: Day 1 after therapy period completion

Population: Participants who completed all protocol-specified assessments were included in the analysis.

The RDQ is a 12 item survey that asks the patient to rate the frequency and severity of GERD symptoms. Each item is scored from 0 to 5 where a score of 0 is equivalent to an asymptomatic state and 5 indicates the worst severity of GERD symptoms. The total RDQ is a sum of all 12 items, and can range from 0 to 60.

Outcome measures

Outcome measures
Measure	Received Zegerid (Ome-NaBic) n=15 Participants Ome-NaBic 40 mg orally 1 h before breakfast and bedtime for up to 29 days
Reflux Disease Questionnaire Score on Day 1 After Therapy Completion	0.5 Units on a scale Standard Deviation 1.5

Adverse Events

Received Zegerid (Ome-NaBic)

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

W. Ray Kim, MD, Chief of Gastroenterology and Hepatology

Stanford University

Phone: 650-725-6511

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place