NCT00700687

Brief Summary

We will evaluate the effect on the gastroduodenal mucosa from oral dosing of three different treatments

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Jun 2008

Shorter than P25 for phase_1 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

June 1, 2008

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 4, 2008

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 19, 2008

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

January 12, 2009

Status Verified

January 1, 2009

Enrollment Period

1 month

First QC Date

June 4, 2008

Last Update Submit

January 9, 2009

Conditions

Healthy

Keywords

cardiovascular prophylactic therapy

Outcome Measures

Primary Outcomes (1)

  • Lanza scores

    entire course of study

Secondary Outcomes (1)

  • safety of three treatments

    entrie course of study

Study Arms (3)

1

EXPERIMENTAL

PA32540

Drug: PA32540

2

EXPERIMENTAL

PA32540 and celecoxib

Drug: PA32540 and celecoxib

3

ACTIVE COMPARATOR

aspirin and celecoxib

Drug: aspirin and [NSAID]

Interventions

PA32540DRUG

aspirin/omeprazole

1
PA32540 and celecoxibDRUG

aspirin/omeprazole and celecoxib

2
aspirin and [NSAID]DRUG

aspirin and \[NSAID\]

3

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Anaheim, California, United States

Location

MeSH Terms

Interventions

CelecoxibAspirinAnti-Inflammatory Agents, Non-Steroidal

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsSalicylatesHydroxybenzoatesPhenolsAnalgesics, Non-NarcoticAnalgesicsSensory System AgentsPeripheral Nervous System AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesAnti-Inflammatory AgentsTherapeutic UsesAntirheumatic Agents

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 4, 2008

First Posted

June 19, 2008

Study Start

June 1, 2008

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

January 12, 2009

Record last verified: 2009-01

Locations

US(1)