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OpenTrials
Completed

NCT Number: NCT00903448

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

The objective of this study is to compare Prilosec OTC® to Prevacid® for gastric acid suppression.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research Site

Oklahoma City, Oklahoma, 73104, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • normal subjects who are age 18-65
  • generally healthy
  • non-childbearing potential females or those using birth control

Exclusion criteria

  • history of significant GI disease
  • any significant medical illness
  • history of hypersensitivity, allergy or intolerance to omeprazole, lansoprazole or other proton pump inhibitors
  • currently using GI medications
  • GI disorder or surgery leading to impaired drug absorption

Treatment and study plan

Prilosec OTC (omeprazole-magnesium)

Drug

Prilosec OTC (omeprazole-magnesium 20.6 mg) tablet to be taken with a glass of water prior to breakfast

Prevacid

Drug

Prevacid (15 mg lansoprazole) capsule to be taken with a glass of water prior to breakfast

Primary outcomes

  1. Mean Percent Time That Gastric pH > 4.0 on Day 5

    Time frame: 24 hours

    for 24 hours starting Day 5 for each period

Sponsors and collaborators

Lead sponsor

Procter and Gamble

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
May 18, 2009
Registry last updated
Dec 31, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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