Study Of Celecoxib In Healthy Subjects

Phase 4

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Placebo; Drug: Celecoxib; Drug: Loxoprofen

• Registration Number: NCT00994461
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-10-13
• Study First Submitted QC: 2009-10-13
• Study First Posted: 2009-10-14
• Study Start: 2009-11
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Results First Submitted: 2011-04-22
• Results First Submitted QC: 2011-04-22
• Results First Posted: 2011-05-17
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-29
• Last Update Posted: 2021-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 190

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Celecoxib	Celecoxib	-
Loxoprofen	Loxoprofen	-

Primary Outcome Measures

Name	Time	Method
Incidence of Gastroduodenal Ulcers	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 Outcome Measures

Name	Time	Method
Incidence of Any Gastric, and Duodenal Ulcers	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	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)	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	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	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	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.)

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇯🇵 Shinjuku-ku, Tokyo, Japan