Phase 4
N=189
Study Of Celecoxib In Healthy Subjects
Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT00994461 ↗Enrolled (actual)
189
Serious AEs
0.0%
Results posted
May 2011
Primary outcome: Primary: Incidence of Gastroduodenal Ulcers — 1.4; 27.6; 2.7 Percent — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Celecoxib (Drug); Loxoprofen (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Gastroduodenal Ulcers |
1.4; 27.6; 2.7 | <0.0001 sig |
| SECONDARY Incidence of Any Gastric, and Duodenal Ulcers |
0; 25.0; 2.7; 1.4; 5.3; 0 | — |
| SECONDARY Incidence of Any Gastroduodenal, Gastric, and Duodenal Ulcers and/or Erosions |
36.5; 53.9; 24.3; 35.1; 53.9; 24.3 | — |
| SECONDARY Post-treatment Gastroduodenal Endoscopic Scores (According to Mucosal Grading Scale) |
38; 33; 22; 8; 2; 6 | — |
| SECONDARY Number of Gastroduodenal Ulcers in Each Subject |
73; 55; 36; 1; 10; 1 | — |
| SECONDARY Number of Gastroduodenal Erosions in Each Subject |
47; 41; 29; 14; 13; 5 | — |
| SECONDARY Incidence of Treatment-emergent, All-causality GI Body System Adverse Events |
24.3; 47.4; 16.2 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00994461). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.