NCT00903448

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_4 healthy

Timeline
Completed

Started Apr 2009

Shorter than P25 for phase_4 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 14, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 18, 2009

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

November 22, 2010

Completed
Last Updated

December 31, 2010

Status Verified

December 1, 2010

Enrollment Period

2 months

First QC Date

May 14, 2009

Results QC Date

August 4, 2010

Last Update Submit

December 22, 2010

Conditions

Healthy

Keywords

Normal Healthy Subject Population

Outcome Measures

Primary Outcomes (1)

  • Mean Percent Time That Gastric pH > 4.0 on Day 5

    for 24 hours starting Day 5 for each period

    24 hours

Study Arms (2)

A

EXPERIMENTAL

Prilosec OTC

Drug: Prilosec OTC (omeprazole-magnesium)

B

ACTIVE COMPARATOR

Prevacid

Drug: Prevacid

Interventions

Prilosec OTC (omeprazole-magnesium)DRUG

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

A
PrevacidDRUG

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

B

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Interventions

OmeprazoleLansoprazole

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
John Mcrorie, PhD, FACG, AGAF
Organization
The Procter & Gamble Company
mcrorie.jw@pg.com
513-622-1423

Study Officials

  • Simon H Magowan, MD

    Procter and Gamble

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 14, 2009

First Posted

May 18, 2009

Study Start

April 1, 2009

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

December 31, 2010

Results First Posted

November 22, 2010

Record last verified: 2010-12

Locations

US(1)