Study Of Celecoxib In Healthy Subjects

This study has been completed.

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00994461

First received: October 13, 2009

Last updated: May 19, 2011

Last verified: May 2011

History of Changes

Results First Received: April 22, 2011

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
Condition:	Healthy Volunteers
Interventions:	Drug: Celecoxib Drug: Loxoprofen Drug: Placebo

Participant Flow

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Baseline Characteristics

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Reporting Groups

	Description
Celecoxib	Celecoxib 100 mg tablet twice a day with meal for 2 weeks
Loxoprofen	Loxoprofen 60 mg tablet three times a day with meal for 2 weeks
Placebo	Placebo tablet three times a day with meal for 2 weeks
Total	Total of all reporting groups

Baseline Measures

	Celecoxib	Loxoprofen	Placebo	Total
Number of Participants [units: participants]	76	76	37	189
Age [units: Years] Mean ± Standard Deviation	56.5 ± 9.65	57.8 ± 9.38	59.1 ± 9.18	57.5 ± 9.45
Gender [units: Participants]
Female	54	55	26	135
Male	22	21	11	54
Helicobacter pylori (H. pylori) status [units: Participants]
Positive	32	33	16	81
Negative	44	43	21	108

Outcome Measures

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1. Primary:

Incidence of Gastroduodenal Ulcers [ Time Frame: 2 weeks ]

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2. Secondary:

Incidence of Any Gastric, and Duodenal Ulcers [ Time Frame: 2 weeks ]

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3. Secondary:

Incidence of Any Gastroduodenal, Gastric, and Duodenal Ulcers and/or Erosions [ Time Frame: 2 weeks ]

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4. Secondary:

Post-treatment Gastroduodenal Endoscopic Scores (According to Mucosal Grading Scale) [ Time Frame: 2 weeks ]

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5. Secondary:

Number of Gastroduodenal Ulcers in Each Subject [ Time Frame: 2 weeks ]

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6. Secondary:

Number of Gastroduodenal Erosions in Each Subject [ Time Frame: 2 weeks ]

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7. Secondary:

Incidence of Treatment-emergent, All-causality GI Body System Adverse Events [ Time Frame: 2 weeks ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com

No publications provided by Pfizer

Publications automatically indexed to this study:

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

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