Study Of Celecoxib In Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00994461
First received: October 13, 2009
Last updated: May 19, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention Phase
Healthy Volunteers
Drug: Celecoxib
Drug: Loxoprofen
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Incidence of Gastroduodenal Ulcers [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Incidence of Any Gastric, and Duodenal Ulcers [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
    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.

  • Incidence of Any Gastroduodenal, Gastric, and Duodenal Ulcers and/or Erosions [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
    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.

  • Post-treatment Gastroduodenal Endoscopic Scores (According to Mucosal Grading Scale) [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
    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)

  • Number of Gastroduodenal Ulcers in Each Subject [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
    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.)

  • Number of Gastroduodenal Erosions in Each Subject [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
    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.)

  • Incidence of Treatment-emergent, All-causality GI Body System Adverse Events [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
    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.)


Enrollment: 190
Study Start Date: November 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Celecoxib Drug: Celecoxib
Celecoxib 100mg tablet twice a day with meal for 2 weeks
Active Comparator: Loxoprofen Drug: Loxoprofen
Loxoprofen 60mg tablet three times a day with meal for 2 weeks
Placebo Comparator: Placebo Drug: Placebo
Placebo tablet three times a day with meal for 2 weeks

  Eligibility

Ages Eligible for Study:   40 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00994461

Locations
Japan
Pfizer Investigational Site
Yokohama, Kanagawa, Japan
Pfizer Investigational Site
Minato-ku, Tokyo, Japan
Pfizer Investigational Site
Shinjuku-ku, Tokyo, Japan
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00994461     History of Changes
Other Study ID Numbers: A3191345
Study First Received: October 13, 2009
Results First Received: April 22, 2011
Last Updated: May 19, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Pfizer:
Endoscopy

Additional relevant MeSH terms:
Loxoprofen
Celecoxib
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 23, 2014