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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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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were screened at 3 centers in Japan.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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

Participant Flow:   Overall Study
    Celecoxib     Loxoprofen     Placebo  
STARTED     76     76     37 [1]
COMPLETED     74     75     37  
NOT COMPLETED     2     1     0  
Adverse Event                 2                 1                 0  
[1] One subject was randomized but did not receive study drug.



  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 ]
  Show Outcome Measure 1

2.  Secondary:   Incidence of Any Gastric, and Duodenal Ulcers   [ Time Frame: 2 weeks ]
  Show Outcome Measure 2

3.  Secondary:   Incidence of Any Gastroduodenal, Gastric, and Duodenal Ulcers and/or Erosions   [ Time Frame: 2 weeks ]
  Hide Outcome Measure 3

Measure Type Secondary
Measure Title Incidence of Any Gastroduodenal, Gastric, and Duodenal Ulcers and/or Erosions
Measure Description 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.
Time Frame 2 weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The m-SAF consisted of all randomized subjects who received at least one dose of the study drug, and underwent endoscopy at baseline and at the end/discontinuation of treatment, as well.

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

Measured Values
    Celecoxib     Loxoprofen     Placebo  
Number of Participants Analyzed  
[units: participants]
 		  74     76     37  
Incidence of Any Gastroduodenal, Gastric, and Duodenal Ulcers and/or Erosions  
[units: Percent]
 		     
Gastroduodenal ulcers and/or erosions     36.5     53.9     24.3  
Gastric ulcers and/or erosions     35.1     53.9     24.3  
Duodenal ulcers and/or erosions     4.1     5.3     0  

No statistical analysis provided for Incidence of Any Gastroduodenal, Gastric, and Duodenal Ulcers and/or Erosions



4.  Secondary:   Post-treatment Gastroduodenal Endoscopic Scores (According to Mucosal Grading Scale)   [ Time Frame: 2 weeks ]
  Show Outcome Measure 4

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 ]
  Show Outcome Measure 6

7.  Secondary:   Incidence of Treatment-emergent, All-causality GI Body System Adverse Events   [ Time Frame: 2 weeks ]
  Show Outcome Measure 7


  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:
unchecked 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.
unchecked 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.


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
No text entered.  


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:


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