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Study Of Celecoxib In Healthy Subjects

Last updated on November 11, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Yokohama, Kanagawa, Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Volunteers
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
40-74 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Healthy Volunteers

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00994461
Pfizer
Completed
Study Of Celecoxib In Healthy Subjects

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Descriptive Information
Brief Title  ICMJE Study Of Celecoxib In Healthy Subjects
Official Title  ICMJE 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
Brief SummaryA 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Drug: Celecoxib
    Celecoxib 100mg tablet twice a day with meal for 2 weeks
  • Drug: Loxoprofen
    Loxoprofen 60mg tablet three times a day with meal for 2 weeks
  • Drug: Placebo
    Placebo tablet three times a day with meal for 2 weeks
Study Arms  ICMJE
  • Experimental: Celecoxib
    Intervention: Drug: Celecoxib
  • Active Comparator: Loxoprofen
    Intervention: Drug: Loxoprofen
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
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.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 20, 2010)
190
Original Estimated Enrollment  ICMJE
 (submitted: October 13, 2009)
185
Actual Study Completion Date  ICMJE April 2010
Actual Primary Completion DateApril 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy Volunteers

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 40 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00994461
Other Study ID Numbers  ICMJE A3191345
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMay 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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