Trial Outcomes & Findings for Comparison of Prilosec Over-the-counter (OTC)® Versus Prevacid® for Gastric Acid Suppression (NCT NCT00903448)

NCT ID: NCT00903448

Last Updated: 2010-12-31

Results Overview

for 24 hours starting Day 5 for each period

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 40 participants
• Primary outcome timeframe: 24 hours
• Results posted on: 2010-12-31

Participant Flow

This single-center, double-blind, randomized, 2-treatment, 3-period cross-over study conducted in forty healthy adult subjects living in the vicinity of the site.

Participant milestones

Measure	Prilosec OTC Then Prevacid Then Prevacid This study was a 3-period crossover (ABB, BAA). Prilosec OTC (20.6 mg omeprazole magnesium tablet) and Prevacid (15 mg lansoprazole capsule) were administered daily before breakfast.	Prevacid Then Prilosec OTC Then Prilosec OTC This study was a 3-period crossover (ABB, BAA). Prilosec OTC (20.6 mg omeprazole magnesium tablet) and Prevacid (15 mg lansoprazole capsule) were administered daily before breakfast.
Period 1: 5 Days Then 10 Day Washout STARTED	20	20
Period 1: 5 Days Then 10 Day Washout COMPLETED	20	20
Period 1: 5 Days Then 10 Day Washout NOT COMPLETED	0	0
Period 2: 5 Days Then 10 Day Washout STARTED	20	20
Period 2: 5 Days Then 10 Day Washout COMPLETED	20	20
Period 2: 5 Days Then 10 Day Washout NOT COMPLETED	0	0
Period 3: 5 Days STARTED	20	20
Period 3: 5 Days COMPLETED	20	20
Period 3: 5 Days NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Prilosec Over-the-counter (OTC)® Versus Prevacid® for Gastric Acid Suppression

Baseline characteristics by cohort

Measure	Entire Study Population n=40 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	40 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	28 years STANDARD_DEVIATION 6.65 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants
Region of Enrollment United States	40 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours

Population: This study was a three period, crossover study of 40 subjects entering either treatment sequence ABB or BAA; consequently each subject in the study participated in three periods over which each subject would eventually receive both Prilosec OTC and Prevacid

for 24 hours starting Day 5 for each period

Outcome measures

Measure	Prilosec OTC Then Prevacid Then Prevacid n=40 Participants This study was a 3-period crossover (ABB, BAA). Prilosec OTC (20.6 mg omeprazole magnesium tablet) and Prevacid (15 mg lansoprazole capsule) were administered daily before breakfast.	Prevacid Then Prilosec OTC Then Prilosec OTC n=40 Participants This study was a 3-period crossover (ABB, BAA). Prilosec OTC (20.6 mg omeprazole magnesium tablet) and Prevacid (15 mg lansoprazole capsule) were administered daily before breakfast.
Mean Percent Time That Gastric pH > 4.0 on Day 5	36.8 percent time gastric pH exceeds 4.0 Standard Error 3.45	45.7 percent time gastric pH exceeds 4.0 Standard Error 3.45

Adverse Events

Prilosec OTC Then Prevacid Then Prevacid

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Prevacid Then Prilosec OTC Then Prilosec OTC

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Prilosec OTC Then Prevacid Then Prevacid n=40 participants at risk This study was a 3-period crossover (ABB, BAA). Prilosec OTC (20.6 mg omeprazole magnesium tablet) and Prevacid (15 mg lansoprazole capsule) were administered daily before breakfast.	Prevacid Then Prilosec OTC Then Prilosec OTC n=40 participants at risk This study was a 3-period crossover (ABB, BAA). Prilosec OTC (20.6 mg omeprazole magnesium tablet) and Prevacid (15 mg lansoprazole capsule) were administered daily before breakfast.
Gastrointestinal disorders Diarrhea	0.00% 0/40	5.0% 2/40 • Number of events 2
Nervous system disorders Headache	0.00% 0/40	2.5% 1/40 • Number of events 1
Skin and subcutaneous tissue disorders Skin Disease	2.5% 1/40 • Number of events 1	0.00% 0/40

Additional Information

John Mcrorie, PhD, FACG, AGAF

The Procter & Gamble Company

Phone: 513-622-1423

Email: mcrorie.jw@pg.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60