Study Of Celecoxib In Healthy Subjects - Full Text View

Purpose

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.

Condition	Intervention	Phase
Healthy Volunteers	Drug: Celecoxib Drug: Loxoprofen Drug: Placebo	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy Peptic Ulcer

Drug Information available for: Celecoxib

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Incidence of Gastroduodenal Ulcers [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
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:

Incidence of Any Gastric, and Duodenal Ulcers [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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.)

Enrollment:	190
Study Start Date:	November 2009
Study Completion Date:	April 2010
Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Celecoxib	Drug: Celecoxib Celecoxib 100mg tablet twice a day with meal for 2 weeks
Active Comparator: Loxoprofen	Drug: Loxoprofen Loxoprofen 60mg tablet three times a day with meal for 2 weeks
Placebo Comparator: Placebo	Drug: Placebo Placebo tablet three times a day with meal for 2 weeks

Eligibility

Ages Eligible for Study:	40 Years to 74 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00994461

Locations

Japan
Pfizer Investigational Site
Yokohama, Kanagawa, Japan
Pfizer Investigational Site
Minato-ku, Tokyo, Japan
Pfizer Investigational Site
Shinjuku-ku, Tokyo, Japan

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Sakamoto C, Kawai T, Nakamura S, Sugioka T, Tabira J. Comparison of gastroduodenal ulcer incidence in healthy Japanese subjects taking celecoxib or loxoprofen evaluated by endoscopy: a placebo-controlled, double-blind 2-week study. Aliment Pharmacol Ther. 2013 Feb;37(3):346-54. doi: 10.1111/apt.12174. Epub 2012 Dec 10.

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00994461 History of Changes
Other Study ID Numbers:	A3191345
Study First Received:	October 13, 2009
Results First Received:	April 22, 2011
Last Updated:	May 19, 2011
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Pfizer:

Endoscopy

Additional relevant MeSH terms:

Loxoprofen
Celecoxib
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013