Comparison of Small Bowel Lesions Associated With Celecoxib Versus Ibuprofen Plus Omeprazole

January 29, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Double-Blind, Placebo-Controlled, Randomized Two-Week Study, Comparing Small Bowel Lesions Associated With Celecoxib (200 mg BID) vs. Ibuprofen (800 mg TID) Plus Omeprazole (20 mg QD)

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
408

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Pfizer Investigational Site
    • California
      • La Jolla, California, United States, 92037
        • Pfizer Investigational Site
      • Los Angeles, California, United States, 90073
        • Pfizer Investigational Site
      • Los Angeles, California, United States, 90033
        • Pfizer Investigational Site
    • Florida
      • Jupiter, Florida, United States, 33458
        • Pfizer Investigational Site
      • Miami, Florida, United States, 33173
        • Pfizer Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Pfizer Investigational Site
      • Rockford, Illinois, United States, 61107
        • Pfizer Investigational Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-0362
        • Pfizer Investigational Site
    • New York
      • New York, New York, United States, 10021
        • Pfizer Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97239
        • Pfizer Investigational Site
    • Tennessee
      • Nashville, Tennessee, United States, 37232-5280
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Inclusion criteria:

  • 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

Exclusion Criteria:

Exclusion criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: A
Drug: Celecoxib
200 mg oral capsule twice daily for 2 weeks
Active Comparator: C
Drug: Ibuprofen plus Omeprazole
ibuprofen 800 mg oral tablet three times daily plus omeprazole 20 mg oral capsule once daily for 2 weeks
Placebo Comparator: B
Other: Placebo
Matched placebo for 2 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of mucosal breaks in the small bowel for each subject
Time Frame: Day 30
Day 30

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Adverse events
Time Frame: Day 30
Day 30
Laboratory tests
Time Frame: Day 30
Day 30
Vital signs
Time Frame: Day 30
Day 30
Correlation of number of mucosal breaks in the small bowel for each patient with the result of the fecal calprotectin test
Time Frame: Day 30
Day 30
Percentage of subjects with gastric mucosal breaks and the number of mucosal breaks
Time Frame: Day 30
Day 30
Change from screening visit in hemoglobin and hematocrit
Time Frame: Day 30
Day 30
Correlation of the number of gastric mucosal breaks with the number of small bowel mucosal breaks
Time Frame: Day 30
Day 30
Physical examination
Time Frame: Day 30
Day 30
Percentage of subjects with >=1 mucosal breaks
Time Frame: Day 30
Day 30
Total number of small bowel lesions with or without hemorrhage
Time Frame: Day 30
Day 30
Percentage of subjects with visible blood in the small bowel (without visualized lesions in the small bowel)
Time Frame: Day 30
Day 30
Change in Patient General Questionnaire Visual Analog Scale from Day 16
Time Frame: Day 30
Day 30
Change in Severity of Dyspepsia Assessment questionnaire from Day 16
Time Frame: Day 30
Day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2003

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2004

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 17, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 21, 2008

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 2, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A3191071

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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