NCT00994461

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
190

participants targeted

Target at P75+ for phase_4 healthy-volunteers

Timeline
Completed

Started Nov 2009

Geographic Reach
1 country

3 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

First Submitted

Initial submission to the registry

October 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 14, 2009

Completed
18 days until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

May 17, 2011

Completed
Last Updated

February 2, 2021

Status Verified

January 1, 2021

Enrollment Period

5 months

First QC Date

October 13, 2009

Results QC Date

April 22, 2011

Last Update Submit

January 29, 2021

Conditions

Healthy Volunteers

Keywords

Endoscopy

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 weeks

Secondary Outcomes (6)

  • Incidence of Any Gastric, and Duodenal Ulcers

    2 weeks

  • Incidence of Any Gastroduodenal, Gastric, and Duodenal Ulcers and/or Erosions

    2 weeks

  • Post-treatment Gastroduodenal Endoscopic Scores (According to Mucosal Grading Scale)

    2 weeks

  • Number of Gastroduodenal Ulcers in Each Subject

    2 weeks

  • Number of Gastroduodenal Erosions in Each Subject

    2 weeks

  • +1 more secondary outcomes

Study Arms (3)

Celecoxib

EXPERIMENTAL
Drug: Celecoxib

Loxoprofen

ACTIVE COMPARATOR
Drug: Loxoprofen

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

CelecoxibDRUG

Celecoxib 100mg tablet twice a day with meal for 2 weeks

Celecoxib
LoxoprofenDRUG

Loxoprofen 60mg tablet three times a day with meal for 2 weeks

Loxoprofen
PlaceboDRUG

Placebo tablet three times a day with meal for 2 weeks

Placebo

Eligibility Criteria

Age40 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy Volunteers

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Pfizer Investigational Site

Yokohama, Kanagawa, Japan

Location

Pfizer Investigational Site

Minato-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Shinjuku-ku, Tokyo, Japan

Location

Related Publications (1)

  • 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.

    PMID: 23216412DERIVED

Related Links

MeSH Terms

Interventions

Celecoxibloxoprofen

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

October 13, 2009

First Posted

October 14, 2009

Study Start

November 1, 2009

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

February 2, 2021

Results First Posted

May 17, 2011

Record last verified: 2021-01

Locations

JP(3)