Study Of Celecoxib In Healthy Subjects

Viatris

Status and phase: Completed; Phase 4

Conditions: Healthy Volunteers

Treatments: Drug: Placebo; Drug: Loxoprofen; Drug: Celecoxib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00994461

A3191345

Details and patient eligibility

About

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.

Enrollment: 190 patients

Sex: All

Ages: 40 to 74 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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190 participants in 3 patient groups, including a placebo group

Celecoxib

Experimental group

Treatment:

Drug: Celecoxib

Loxoprofen

Active Comparator group

Treatment:

Drug: Loxoprofen

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo