Bowel Diseases, InflammatoryPhase 4NCT00640809
Comparison of Small Bowel Lesions Associated With Celecoxib Versus Ibuprofen Plus Omeprazole
A Phase 4 study testing Celecoxib and Ibuprofen plus Omeprazole in people with Bowel Diseases, Inflammatory, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 12 sites in United States.
Trial summary
To evaluate the small bowel lesion pattern associated with celecoxib alone versus ibuprofen plus omeprazole Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Bowel Diseases, Inflammatory
- What is being tested?
- Celecoxib and Ibuprofen plus Omeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 408 participants
- Where
- 12 sitesUnited States
- Study dates
- Oct 2003to Apr 2004
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Pfizer Investigational Site
Ann Arbor, Michigan, 48109-0362
Pfizer Investigational Site
Chicago, Illinois, 60612
Pfizer Investigational Site
Jupiter, Florida, 33458
Pfizer Investigational Site
La Jolla, California, 92037
Pfizer Investigational Site
Los Angeles, California, 90033
Pfizer Investigational Site
Los Angeles, California, 90073
Pfizer Investigational Site
Miami, Florida, 33173
Pfizer Investigational Site
Nashville, Tennessee, 37232-5280
Pfizer Investigational Site
New York, New York, 10021
Pfizer Investigational Site
Portland, Oregon, 97239
Pfizer Investigational Site
Rockford, Illinois, 61107
Pfizer Investigational Site
Scottsdale, Arizona, 85259
About this study
Official title: 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
- Conditions
- Bowel Diseases, Inflammatory
- Being tested
- Celecoxib, Placebo, Ibuprofen plus Omeprazole
- Keywords
- Bowel Disease
- Medical subject headings
- Inflammatory Bowel Diseases, Intestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelecoxibDrug
200 mg oral capsule twice daily for 2 weeks
PlaceboOther
Matched placebo for 2 weeks
Ibuprofen plus OmeprazoleDrug
ibuprofen 800 mg oral tablet three times daily plus omeprazole 20 mg oral capsule once daily for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: Celecoxib |
| B | Placebo comparator | Not described Receives: Other: Placebo |
| C | Active comparator | Not described Receives: Drug: Ibuprofen plus Omeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of mucosal breaks in the small bowel for each subject
Measured: Day 30
Secondary outcomes (13)
Adverse events
Measured: Day 30
Laboratory tests
Measured: Day 30
Vital signs
Measured: Day 30
Correlation of number of mucosal breaks in the small bowel for each patient with the result of the fecal calprotectin test
Measured: Day 30
Percentage of subjects with gastric mucosal breaks and the number of mucosal breaks
Measured: Day 30
Change from screening visit in hemoglobin and hematocrit
Measured: Day 30
Correlation of the number of gastric mucosal breaks with the number of small bowel mucosal breaks
Measured: Day 30
Physical examination
Measured: Day 30
Percentage of subjects with >=1 mucosal breaks
Measured: Day 30
Total number of small bowel lesions with or without hemorrhage
Measured: Day 30
Percentage of subjects with visible blood in the small bowel (without visualized lesions in the small bowel)
Measured: Day 30
Change in Patient General Questionnaire Visual Analog Scale from Day 16
Measured: Day 30
Change in Severity of Dyspepsia Assessment questionnaire from Day 16
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2008 (estimated)
- Study startOct 2003
- Study completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel Diseases, InflammatoryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 408 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00640809
- Sponsor's protocol ID
- A3191071
- Status last verified
- Jan 2021
- First submitted
- 17 Mar 2008
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT00640809
- Acronym / sponsor ID
- A3191071
- Conditions
- Bowel Diseases, Inflammatory
- Keywords
- Bowel Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 408 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2003
- Study completion
- Apr 2004 (actual)
- First posted
- 21 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the small bowel lesion pattern associated with celecoxib alone versus ibuprofen plus omeprazole
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Celecoxib |
| B | Placebo comparator | Other: Placebo |
| C | Active comparator | Drug: Ibuprofen plus Omeprazole |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Celecoxib200 mg oral capsule twice daily for 2 weeks | Drug | A |
| PlaceboMatched placebo for 2 weeks | Other | B |
| Ibuprofen plus Omeprazoleibuprofen 800 mg oral tablet three times daily plus omeprazole 20 mg oral capsule once daily for 2 weeks | Drug | C |
Primary outcome
Number of mucosal breaks in the small bowel for each subject
Time frame: Day 30
13 secondary outcomes
Adverse events
Time frame: Day 30
Laboratory tests
Time frame: Day 30
Vital signs
Time frame: 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
Percentage of subjects with gastric mucosal breaks and the number of mucosal breaks
Time frame: Day 30
Change from screening visit in hemoglobin and hematocrit
Time frame: Day 30
Correlation of the number of gastric mucosal breaks with the number of small bowel mucosal breaks
Time frame: Day 30
Physical examination
Time frame: Day 30
Percentage of subjects with >=1 mucosal breaks
Time frame: Day 30
Total number of small bowel lesions with or without hemorrhage
Time frame: Day 30
Percentage of subjects with visible blood in the small bowel (without visualized lesions in the small bowel)
Time frame: Day 30
Change in Patient General Questionnaire Visual Analog Scale from Day 16
Time frame: Day 30
Change in Severity of Dyspepsia Assessment questionnaire from Day 16
Time frame: Day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Celecoxib and Ibuprofen plus Omeprazole in people with Bowel Diseases, Inflammatory, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of mucosal breaks in the small bowel for each subject (time frame: Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2021.