You are here

Study Of Celecoxib In Healthy Subjects

Last updated on August 9, 2018

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.
Show details

- 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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

Healthy Volunteers
NCT03184168
Males
18+
Years
Madison, Wisconsin
Healthy, Chronic Rhinosinusitis With Nasal Polyps, Atopic Dermatitis
NCT02743871
All Genders
18+
Years
Multiple Sites
Study Of Celecoxib In Healthy Subjects
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Healthy Volunteers
  • 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
  • Experimental: Celecoxib
    Intervention: Drug: Celecoxib
  • Active Comparator: Loxoprofen
    Intervention: Drug: Loxoprofen
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
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.
 
Completed
190
April 2010
April 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
40 Years to 74 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00994461
A3191345
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 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 thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now