NCT00640809

Brief Summary

To evaluate the small bowel lesion pattern associated with celecoxib alone versus ibuprofen plus omeprazole

Trial Health

87
On Track

Trial Health Score

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

Enrollment
408

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2003

Shorter than P25 for phase_4

Geographic Reach
1 country

12 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

October 1, 2003

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2004

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 21, 2008

Completed
Last Updated

February 2, 2021

Status Verified

January 1, 2021

First QC Date

March 17, 2008

Last Update Submit

January 29, 2021

Conditions

Bowel Diseases, Inflammatory

Keywords

Bowel Disease

Outcome Measures

Primary Outcomes (1)

  • Number of mucosal breaks in the small bowel for each subject

    Day 30

Secondary Outcomes (13)

  • Adverse events

    Day 30

  • Laboratory tests

    Day 30

  • Vital signs

    Day 30

  • Correlation of number of mucosal breaks in the small bowel for each patient with the result of the fecal calprotectin test

    Day 30

  • Percentage of subjects with gastric mucosal breaks and the number of mucosal breaks

    Day 30

  • +8 more secondary outcomes

Study Arms (3)

A

EXPERIMENTAL
Drug: Celecoxib

B

PLACEBO COMPARATOR
Other: Placebo

C

ACTIVE COMPARATOR
Drug: Ibuprofen plus Omeprazole

Interventions

CelecoxibDRUG

200 mg oral capsule twice daily for 2 weeks

A
PlaceboOTHER

Matched placebo for 2 weeks

B
Ibuprofen plus OmeprazoleDRUG

ibuprofen 800 mg oral tablet three times daily plus omeprazole 20 mg oral capsule once daily for 2 weeks

C

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Normal, healthy gastrointestinal tract (no small bowel mucosal breaks at Day 14 according to endoscopic data
  • No history of GI ulcers, bleeding or surgery, or complete or partial stenosis of the small intestine
  • Willing not to drink any alcohol during study period

You may not qualify if:

  • Has established delayed gastric emptying or diabetic gastroparesis
  • Has active gastroesophageal reflux disease or requires anti-ulcer medications
  • Has taken aspirin or nonsteroidal antinflammatory drugs (ibuprofen, naproxen) more than 3 times per week within 2 weeks prior to the screening visit; aspirin for cardiovascular prophylaxis is restricted

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Pfizer Investigational Site

Scottsdale, Arizona, 85259, United States

Location

Pfizer Investigational Site

La Jolla, California, 92037, United States

Location

Pfizer Investigational Site

Los Angeles, California, 90033, United States

Location

Pfizer Investigational Site

Los Angeles, California, 90073, United States

Location

Pfizer Investigational Site

Jupiter, Florida, 33458, United States

Location

Pfizer Investigational Site

Miami, Florida, 33173, United States

Location

Pfizer Investigational Site

Chicago, Illinois, 60612, United States

Location

Pfizer Investigational Site

Rockford, Illinois, 61107, United States

Location

Pfizer Investigational Site

Ann Arbor, Michigan, 48109-0362, United States

Location

Pfizer Investigational Site

New York, New York, 10021, United States

Location

Pfizer Investigational Site

Portland, Oregon, 97239, United States

Location

Pfizer Investigational Site

Nashville, Tennessee, 37232-5280, United States

Location

Related Links

MeSH Terms

Conditions

Inflammatory Bowel DiseasesIntestinal Diseases

Interventions

CelecoxibIbuprofenOmeprazole

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPhenylpropionatesAcids, CarbocyclicCarboxylic Acids2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesPyridinesBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2008

First Posted

March 21, 2008

Study Start

October 1, 2003

Study Completion

April 1, 2004

Last Updated

February 2, 2021

Record last verified: 2021-01

Locations

US(12)