Trial Outcomes & Findings for Comparison of Prilosec OTC® Versus Zegerid® for Gastric Acid Suppression (NCT NCT00808769)

Results Overview

In this study, there was evidence of gastric pH probe failure and a high incidence of biologically improbable pH measurements (sustained pH \< 1.0) that bring the validity of the results into question. The results of this study are, therefore, inconclusive.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

30 participants

Primary outcome timeframe

continuously over a 24 hour period

Results posted on

2015-06-01

Participant Flow

The study period of this study was November 25 to December 21, 2008

Participant milestones

Participant milestones
Measure	Zegerid® Then Prilosec OTC® Zegerid® (20 mg omeprazole/sodium bicarbonate) then Prilosec OTC® (20.6 mg omeprazole magnesium)	Prilosec OTC® Then Zegerid® Prilosec OTC® (omeprazole magnesium 20.6 mg) then Zegerid® (20 mg omeprazole/sodium bicarbonate)
First Intervention STARTED	15	15
First Intervention COMPLETED	15	15
First Intervention NOT COMPLETED	0	0
Second Intervention STARTED	15	15
Second Intervention COMPLETED	15	15
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Prilosec OTC® Versus Zegerid® for Gastric Acid Suppression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=30 Participants
Age, Categorical <=18 years	0 Participants n=39 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=39 Participants
Age, Categorical >=65 years	0 Participants n=39 Participants
Age, Continuous	26.4 years STANDARD_DEVIATION 4.47 • n=39 Participants
Sex: Female, Male Female	8 Participants n=39 Participants
Sex: Female, Male Male	22 Participants n=39 Participants
Region of Enrollment United States	30 participants n=39 Participants

PRIMARY outcome

Timeframe: continuously over a 24 hour period

Population: Zeros are entered because the data are corrupted for 2 reasons: probe calibration failure rate was \~10x higher than historically documented, and the probes that calibrated had a high incidence of prolonged pH \< 1.0 (highly physiologically improbable). This calls into question the credibility and interpretability of all the pH data.

In this study, there was evidence of gastric pH probe failure and a high incidence of biologically improbable pH measurements (sustained pH \< 1.0) that bring the validity of the results into question. The results of this study are, therefore, inconclusive.

Outcome measures

Outcome data not reported

Adverse Events

Zegerid® Then Prilosec OTC®

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Prilosec OTC® Then Zegerid®

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

John Mcrorie, PhD, FACG, AGAF

The Procter & Gamble Company

Phone: 513-622-1423

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER