Healthy VolunteersPhase 4NCT00994461

Study Of Celecoxib In Healthy Subjects

A Phase 4 study testing Celecoxib and Loxoprofen in people with Healthy Volunteers, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 3 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A study to confirm the superiority of celecoxib 100 mg BID to loxoprofen 60 mg TID in the incidence of gastroduodenal endoscopic ulcers after 2 weeks treatment. Read more about this study

Who is it for?: Ages 40 to 74 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Celecoxib and Loxoprofen
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 190 participants
Where: 3 sitesJapan
Study dates: Nov 2009to Apr 2010
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 40 to 74 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy Volunteers

Who cannot join

Endoscopic evidence of ulceration, erosion or active bleeding etc. in the esophagus, stomach, pylorus and/or duodenum prior to treatment endoscopy
A history of gastrointestinal ulcer
Any use of celecoxib, nonsteroidal anti-inflammatory drugs (including aspirin), anti-ulcer medication, antacids, systemic steroids or antibiotics within four weeks prior to the first dose of study medication

Trial locations and contacts

3 sites in 1 country.

Japan3 sites

Pfizer Investigational Site
Minato-ku, Tokyo
Pfizer Investigational Site
Shinjuku-ku, Tokyo
Pfizer Investigational Site
Yokohama, Kanagawa

Other trials in Japan

About this study

Official title: A Randomized, Placebo-Controlled, Double-Blind, Phase 4 Study To Compare The Effect Of Celecoxib 100 Mg BID, Loxoprofen 60 Mg TID And Placebo On The Gastroduodenal Mucosa In Healthy Subjects

A study to confirm the superiority of celecoxib 100 mg BID to loxoprofen 60 mg TID in the incidence of gastroduodenal endoscopic ulcers after 2 weeks treatment.

Conditions: Healthy Volunteers
Being tested: Celecoxib, Loxoprofen, Placebo
Keywords: Endoscopy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CelecoxibDrug
Celecoxib 100mg tablet twice a day with meal for 2 weeks
LoxoprofenDrug
Loxoprofen 60mg tablet three times a day with meal for 2 weeks
PlaceboDrug
Placebo tablet three times a day with meal for 2 weeks

Study groups in NCT00994461
Study group	Role	What they receive
Celecoxib	Experimental	Not described Receives: Drug: Celecoxib
Loxoprofen	Active comparator	Not described Receives: Drug: Loxoprofen
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Gastroduodenal Ulcers
The percentage of subjects who had gastroduodenal endoscopic ulcers after 2 weeks treatment (The number of subjects who had gastroduodenal endoscopic ulcers after 2 weeks treatment divided by participants multiplied by 100.) An ulcer is defined as any break in the mucosa at least 3 mm in diameter with unequivocal depth.
Measured: 2 weeks

Secondary outcomes (6)

Incidence of Any Gastric, and Duodenal Ulcers
The percentage of subjects who had gastric and duodenal endoscopic ulcers after 2 weeks treatment (The number of subjects who had gastric and duodenal endoscopic ulcers after 2 weeks treatment divided by participants multiplied by 100.) An ulcer is defined as any break in the mucosa at least 3 mm in diameter with unequivocal depth.
Measured: 2 weeks
Incidence of Any Gastroduodenal, Gastric, and Duodenal Ulcers and/or Erosions
The percentage of subjects who had gastroduodenal, gastric, and duodenal endoscopic ulcers and/or erosions after 2 weeks treatment (The number of subjects who had gastroduodenal, gastric, and duodenal endoscopic ulcers and/or erosions after 2 weeks treatment divided by participants multiplied by 100.) An ulcer is defined as any break in the mucosa at least 3 mm in diameter with unequivocal depth. An erosion is defined as a lesion producing a definite break in the mucosa with equivocal depth.
Measured: 2 weeks
Post-treatment Gastroduodenal Endoscopic Scores (According to Mucosal Grading Scale)
Number of subjects for each gastroduodenal endoscopic score (according to Mucosal Grading Scale) after 2 weeks treatment (Score 0 = normal mucosa (no visible lesions); Score 1 = 1 to 10 petechiae; Score 2 = more than 10 petechiae; Score 3 = 1 to 5 erosions; Score 4 = 6 to 10 erosions; Score 5 = 11 to 25 erosions; Score 6 = more than 25 erosions; Score 7 = ulcer)
Measured: 2 weeks
Number of Gastroduodenal Ulcers in Each Subject
Number of subjects for each number of gastroduodenal endoscopic ulcers after 2 weeks treatment (An ulcer is defined as any break in the mucosa at least 3 mm in diameter with unequivocal depth.)
Measured: 2 weeks
Number of Gastroduodenal Erosions in Each Subject
Number of subjects for each number of gastroduodenal endoscopic erosions after 2 weeks treatment (An erosion is defined as a lesion producing a definite break in the mucosa with equivocal depth.)
Measured: 2 weeks
Incidence of Treatment-emergent, All-causality GI Body System Adverse Events
The percentage of subjects who had treatment-emergent, all-causality gastrointestinal body system adverse events after 2 weeks treatment (The number of subjects who had treatment-emergent, all-causality gastrointestinal body system adverse events after 2 weeks treatment divided by participants multiplied by 100.)
Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2009Apr 2010

First posted14 Oct 2009 (estimated)
Study startNov 2009
Primary completionApr 2010
Study completionApr 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Healthy VolunteersStudies 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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 190 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00994461
Sponsor's protocol ID: A3191345
Status last verified: Jan 2021
First submitted: 13 Oct 2009
Last updated: 2 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Sakamoto C, Kawai T, Nakamura S, Sugioka T, Tabira J. Comparison of gastroduodenal ulcer incidence in healthy Japanese subjects taking celecoxib or loxoprofen evaluated by endoscopy: a placebo-controlled, double-blind 2-week study. Aliment Pharmacol Ther. 2013 Feb;37(3):346-54. doi: 10.1111/apt.12174. Epub 2012 Dec 10.
PubMed 23216412

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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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: A Randomized, Placebo-Controlled, Double-Blind, Phase 4 Study To Compare The Effect Of Celecoxib 100 Mg BID, Loxoprofen 60 Mg TID And Placebo On The Gastroduodenal Mucosa In Healthy Subjects
ClinicalTrials.gov ID: NCT00994461
Acronym / sponsor ID: A3191345
Conditions: Healthy Volunteers
Keywords: Endoscopy
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 190 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Nov 2009
Primary completion: Apr 2010 (actual)
Study completion: Apr 2010 (actual)
First posted: 14 Oct 2009 (estimated)
Results: Posted 17 May 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A study to confirm the superiority of celecoxib 100 mg BID to loxoprofen 60 mg TID in the incidence of gastroduodenal endoscopic ulcers after 2 weeks treatment.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Celecoxib	Experimental	Drug: Celecoxib
Loxoprofen	Active comparator	Drug: Loxoprofen
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 40 to 74 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Healthy Volunteers

Key exclusion criteria (3 listed)

Endoscopic evidence of ulceration, erosion or active bleeding etc. in the esophagus, stomach, pylorus and/or duodenum prior to treatment endoscopy
A history of gastrointestinal ulcer
Any use of celecoxib, nonsteroidal anti-inflammatory drugs (including aspirin), anti-ulcer medication, antacids, systemic steroids or antibiotics within four weeks prior to the first dose of study medication

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
CelecoxibCelecoxib 100mg tablet twice a day with meal for 2 weeks	Drug	Celecoxib
LoxoprofenLoxoprofen 60mg tablet three times a day with meal for 2 weeks	Drug	Loxoprofen
PlaceboPlacebo tablet three times a day with meal for 2 weeks	Drug	Placebo

Primary outcome

Incidence of Gastroduodenal Ulcers
Time frame: 2 weeks
The percentage of subjects who had gastroduodenal endoscopic ulcers after 2 weeks treatment (The number of subjects who had gastroduodenal endoscopic ulcers after 2 weeks treatment divided by participants multiplied by 100.) An ulcer is defined as any break in the mucosa at least 3 mm in diameter with unequivocal depth.

6 secondary outcomes

Incidence of Any Gastric, and Duodenal Ulcers
Time frame: 2 weeks
Incidence of Any Gastroduodenal, Gastric, and Duodenal Ulcers and/or Erosions
Time frame: 2 weeks
Post-treatment Gastroduodenal Endoscopic Scores (According to Mucosal Grading Scale)
Time frame: 2 weeks
Number of Gastroduodenal Ulcers in Each Subject
Time frame: 2 weeks
Number of Gastroduodenal Erosions in Each Subject
Time frame: 2 weeks
Incidence of Treatment-emergent, All-causality GI Body System Adverse Events
Time frame: 2 weeks

Results and safety

Results posted to the registry on 17 May 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Celecoxib	76	74
Loxoprofen	76	75
Placebo	37	37

Primary outcome: Incidence of Gastroduodenal Ulcers

Time frame: 2 weeks. Number. Unit: Percent

Measure	Celecoxib n = 74	Loxoprofen n = 76	Placebo n = 37
Value	1.4	27.6	2.7

Celecoxib vs Loxoprofen: p <0.0001, Cochran-Mantel-Haenszel

Population analysed: The modified-safety analysis set (m-SAF) consisted of all randomized subjects who received at least one dose of the study drug, and underwent endoscopy at baseline and at the end/discontinuation of treatment, as well.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 2 weeks. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Celecoxib	0 of 76 (0%)	19 of 76 (25%)	Not reported
Loxoprofen	0 of 76 (0%)	37 of 76 (48.7%)	Not reported
Placebo	0 of 37 (0%)	8 of 37 (21.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23216412Sakamoto C, Kawai T, Nakamura S, Sugioka T, Tabira J. Comparison of gastroduodenal ulcer incidence in healthy Japanese subjects taking celecoxib or loxoprofen evaluated by endoscopy: a placebo-controlled, double-blind 2-week study. Aliment Pharmacol Ther. 2013 Feb;37(3):346-54. doi: 10.1111/apt.12174. Epub 2012 Dec 10.
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

3 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 Loxoprofen in people with Healthy Volunteers, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 3 sites in Japan.

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 1 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 3 sites in Japan. 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?

Yes. Results are posted in the registry (first posted 17 May 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Incidence of Gastroduodenal Ulcers (time frame: 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00994461, which also lists 1 linked publication.

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; AzTrials last refreshed its copy on 7 Nov 2026.