NCT00195208

Brief Summary

The purpose of this study is to demonstrate pharmacodynamic comparability between the pantoprazole spheroid formulation and the marketed tablet formulation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
97

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2005

Shorter than P25 for phase_3

Geographic Reach
1 country

9 active sites

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

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

February 8, 2013

Status Verified

February 1, 2013

Enrollment Period

5 months

First QC Date

September 12, 2005

Last Update Submit

February 7, 2013

Conditions

Gastroesophageal RefluxEsophagitis

Keywords

Gastroesophageal Reflux Disease (GERD)

Outcome Measures

Primary Outcomes (1)

  • Comparison of MAO between the two formulations.

Secondary Outcomes (1)

  • Comparison of BAO and pH parameters between the two formulations.

Interventions

Pantoprazole for approximately 9 weeksDRUG

Eligibility Criteria

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

You may qualify if:

  • GERD and a history of Erosive Esophagitis documented by endoscopy
  • H. pylori negative

You may not qualify if:

  • Gastrointestinal conditions such as esophageal stricture, esophageal varices, previous vagotomy
  • Achlorhydria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Unknown Facility

Anaheim, California, 92801, United States

Location

Unknown Facility

Los Angeles, California, 90073, United States

Location

Unknown Facility

Orange, California, 92869, United States

Location

Unknown Facility

San Diego, California, 92103, United States

Location

Unknown Facility

Miami, Florida, 33173, United States

Location

Unknown Facility

Oklahoma City, Oklahoma, 73104, United States

Location

Unknown Facility

Oklahoma City, Oklahoma, 73112, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, 19104, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, 19140, United States

Location

MeSH Terms

Conditions

Gastroesophageal RefluxEsophagitis

Interventions

Pantoprazole

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesGastroenteritis

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

June 1, 2005

Primary Completion

November 1, 2005

Study Completion

November 1, 2005

Last Updated

February 8, 2013

Record last verified: 2013-02

Locations

US(9)