Study Of Celecoxib In Healthy Subjects

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Selective COX-2 Inhibition on Ulcer Healing

NCT00153673

Arthritis Gastric Ulcer

COMPLETED PHASE3

Preventing Recurrent Ulcer Bleeding in Arthritis Patients Using Esomeprazole Plus Celecoxib

NCT00365313

Arthritis Bleeding Ulcer

COMPLETED PHASE3

Video Capsule Endoscopy to Investigate the Safety and Tolerability of Lumiracoxib in the Small Bowel

NCT00350155

Healthy Volunteers

COMPLETED PHASE4

A Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Japanese Participants With Eosinophilic Gastroenteritis

NCT05214768

Eosinophilic Gastroenteritis

COMPLETED PHASE3

Celecoxib Versus Naproxen for Prevention of Recurrent Ulcer Bleeding in Arthritis Patients

NCT00153660

Arthritis Cardiovascular Diseases Cerebrovascular Disorders

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Celecoxib

Group Type EXPERIMENTAL

Celecoxib

Intervention Type DRUG

Celecoxib 100mg tablet twice a day with meal for 2 weeks

Loxoprofen

Group Type ACTIVE_COMPARATOR

Loxoprofen

Intervention Type DRUG

Loxoprofen 60mg tablet three times a day with meal for 2 weeks

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablet three times a day with meal for 2 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Celecoxib

Celecoxib 100mg tablet twice a day with meal for 2 weeks

Intervention Type DRUG

Loxoprofen

Loxoprofen 60mg tablet three times a day with meal for 2 weeks

Intervention Type DRUG

Placebo

Placebo tablet three times a day with meal for 2 weeks

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

40 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes