Study Of Celecoxib In Healthy Subjects

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: April 2010

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: Celecoxib
  • Active Comparator: Loxoprofen
  • Placebo Comparator: Placebo

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • Incidence of Any Gastric, and Duodenal Ulcers
    • Time Frame: 2 weeks
    • 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
    • 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
    • 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
    • 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
    • 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
    • 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.)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 74 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Pfizer’s Upjohn has merged with Mylan to form Viatris Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Pfizer CT.gov Call Center, Study Director, Pfizer

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