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Trial record 81 of 543 for:    Celecoxib

Observational Familial Adenomatous Polyposis Registry Study In Patients Receiving Celecoxib Compared to Control Patients

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ClinicalTrials.gov Identifier: NCT00151476
Recruitment Status : Terminated (See Detailed Description)
First Posted : September 9, 2005
Results First Posted : March 4, 2010
Last Update Posted : March 9, 2010
Sponsor:
Information provided by:
Pfizer

Study Type Observational
Study Design Observational Model: Cohort
Condition Familial Adenomatous Polyposis (FAP)
Interventions Drug: Celecoxib
Other: Routine Medical Care
Enrollment 68
Recruitment Details Study prematurely discontinued in May 2008 prior to reaching planned enrollment target; Last subject last visit November 2008.
Pre-assignment Details Familial Adenomatous Polyposis (FAP) identified subjects=celecoxib-treated and matched control subjects eligible for inclusion in study identified from 4 registry sites; FAP analyzed=celecoxib-treated and matched control subjects eligible for matching and analysis in study. 1 subject excluded from analysis; took celecoxib without a prescription.
Arm/Group Title Matched Control All Celecoxib Treated
Hide Arm/Group Description Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: all patients regardless of treatment status are followed according to local standard of medical care by the respective physicians. All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
Period Title: FAP Identified Subjects
Started 13 55
Completed 13 54
Not Completed 0 1
Reason Not Completed
Protocol Violation             0             1
Period Title: FAP Analyzed Subjects
Started 13 54
Completed 13 51
Not Completed 0 3
Reason Not Completed
Lost to Follow-up             0             2
Other study participation             0             1
Arm/Group Title Matched Celecoxib Treated Matched Control Not Matched Celecoxib Treated Total
Hide Arm/Group Description Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians. Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: all patients regardless of treatment status are followed according to local standard of medical care by the respective physicians. Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians. Total of all reporting groups
Overall Number of Baseline Participants 13 13 41 67
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 41 participants 67 participants
<25 years 4 5 18 27
25 to 34 years 5 4 5 14
35 to 44 years 3 2 8 13
45 to 54 years 1 1 3 5
55 to 64 years 0 0 1 1
>64 years 0 0 0 0
Age not available (no surgery) 0 1 6 7
[1]
Measure Description: Age range groups at most recent FAP-related surgery (years). Prior to start of study follow-up = prior to baseline. Start of study follow-up: start of on-study celecoxib treatment period for celecoxib-treated subjects and index date for control subjects = baseline.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 41 participants 67 participants
Female
2
  15.4%
6
  46.2%
21
  51.2%
29
  43.3%
Male
11
  84.6%
7
  53.8%
20
  48.8%
38
  56.7%
1.Primary Outcome
Title Time From Ileorectal Anastomosis (IRA) to Time of First Excisional Polypectomy of a Rectal Polyp Post IRA
Hide Description Time(months): [date of first excisional polypectomy of rectal polyp post IRA minus date of prior IRA plus 1] divided by 30.44. Baseline = start of study follow-up: start of on-study celecoxib treatment period for celecoxib-treated subjects and comparable to index date for control subjects. Index date calculated as Matched Celecoxib-treated patients: number of days from most recent FAP-related surgery (IRA or IPAA) to start of study follow-up; add this number of days to matched control patient’s most recent FAP-related surgery date=index date for Matched Control.
Time Frame Up to 8 years prior to baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible subjects with IRA performed prior to start of study follow-up; first excisional polypectomy of rectal polyp post IRA. Polyp size unavailable for many subjects; not considered in analysis.
Arm/Group Title Matched Celecoxib Treated Matched Control Not Matched Celecoxib Treated All Celecoxib Treated
Hide Arm/Group Description:
Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
Overall Number of Participants Analyzed 4 2 26 30
Mean (Standard Deviation)
Unit of Measure: months
86.4  (143.78) 4.0  (3.25) 78.4  (102.01) 79.5  (105.44)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Matched Celecoxib Treated
Comments

Time to FAP-related surgical events (months); twenty-fifth (25th) percentile presented due to limited number of subjects.

Index date based on most recent colon and or rectum adenomatous polyps evaluation, most recent duodenal adenomatous polyps evaluation, and most recent desmoids tumors evaluation for Matched Control, Not Matched Celecoxib, and All Celecoxib Treated, respectively.

Only 13 matched pairs identified: p-values not computed in analysis of time-to-event endpoints

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Kaplan-Meier Estimate of Time to Event
Estimated Value 14.49
Confidence Interval 95%
3.48 to 301.64
Estimation Comments Kaplan-Meier Estimate of Time to Event (months).
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Not Matched Celecoxib Treated
Comments Time to FAP-related surgical events (months); 25th percentile.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Kaplan-Meier Estimate of Time to Event
Estimated Value 5.06
Confidence Interval 95%
3.48 to 11.76
Estimation Comments Kaplan-Meier Estimate of Time to Event (months).
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection All Celecoxib Treated
Comments Time to FAP-related surgical events (months); 25th percentile.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Kaplan-Meier Estimate of Time to Event
Estimated Value 5.52
Confidence Interval 95%
3.48 to 14.49
Estimation Comments Kaplan-Meier Estimate of Time to Event (months).
2.Primary Outcome
Title Time From Start of Study Follow-up to the Time of First Excisional Polypectomy of a Rectal Polyp Post IRA
Hide Description Time(months): [date of first excisional polypectomy of rectal polyp post IRA minus date of start of study follow-up plus 1] divided by 30.44.
Time Frame Baseline, Up to 60 months post-baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible subjects with IRA performed prior to start of study follow-up included, except left-censored subjects (had first excisional polypectomy of rectal polyp post IRA prior to start of study follow-up). No control group subjects (n=3) had a post-IRA polypectomy (no data).
Arm/Group Title Matched Celecoxib Treated Matched Control Not Matched Celecoxib Treated All Celecoxib Treated
Hide Arm/Group Description:
Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
Overall Number of Participants Analyzed 1 0 5 6
Median (Full Range)
Unit of Measure: months
19.8
(19.8 to 19.8)
32.1
(0.0 to 44.1)
25.9
(0.0 to 44.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Not Matched Celecoxib Treated
Comments Time to FAP-related surgical events (months); 25th percentile.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Kaplan-Meier Estimate of Time to Event
Estimated Value 5.98
Confidence Interval 95%
0.00 to 33.77
Estimation Comments Kaplan-Meier Estimate of Time to Event (months).
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection All Celecoxib Treated
Comments Time to FAP-related surgical events (months); 25th percentile.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Kaplan-Meier Estimate of Time to Event
Estimated Value 19.81
Confidence Interval 95%
0.00 to 33.77
Estimation Comments Kaplan-Meier Estimate of Time to Event (months).
3.Primary Outcome
Title Time From Ileopouch Anal Anastomosis (IPAA) to Time of First Excisional Polypectomy of a Rectal Polyp Post IPAA
Hide Description Time (months): [date of first excisional polypectomy of a rectal polyp post IPAA minus date of prior IPAA plus 1] divided by 30.44. Baseline = start of study follow-up: start of on-study celecoxib treatment period for celecoxib-treated subjects and comparable to index date for control subjects. Index date calculated as Matched Celecoxib-treated patients: number of days from most recent FAP-related surgery (IRA or IPAA) to start of study follow-up; add this number of days to matched control patient’s most recent FAP-related surgery date=index date for Matched Control.
Time Frame Up to 15 years prior to baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible subjects with IPAA performed prior to start of study follow-up included and with first excisional polypectomy of a rectal polyp post IPAA. No control group subjects (n=7) had a post-IPAA polypectomy (no data).
Arm/Group Title Matched Celecoxib Treated Matched Control Not Matched Celecoxib Treated All Celecoxib Treated
Hide Arm/Group Description:
Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
Overall Number of Participants Analyzed 3 0 0 3
Mean (Standard Deviation)
Unit of Measure: months
152.7  (42.10) 152.7  (42.10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Matched Celecoxib Treated
Comments Time to FAP-related surgical events (months); 25th percentile. Index date based on most recent colon and or rectum adenomatous polyps evaluation, most recent duodenal adenomatous polyps evaluation, and most recent desmoids tumors evaluation for Matched Control, Not Matched Celecoxib, and All Celecoxib Treated, respectively.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Kaplan-Meier Estimate of Time to Event
Estimated Value 137.34
Confidence Interval 95%
104.73 to 183.48
Estimation Comments Kaplan-Meier Estimate of Time to Event (months).
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection All Celecoxib Treated
Comments Time to FAP-related surgical events (months); 25th percentile.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Kaplan-Meier Estimate of Time to Event
Estimated Value 169.94
Confidence Interval 95%
104.73 to 183.48
Estimation Comments Kaplan-Meier Estimate of Time to Event (months).
4.Primary Outcome
Title Time From Start of Study Follow-up to Time of First Excisional Polypectomy of a Rectal Polyp Post IPAA
Hide Description Time (months): [date of first excisional polypectomy of rectal polyp post IPAA minus date of start of study follow-up plus 1] divided by 30.44.
Time Frame Baseline, Up to 60 months post-baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible subjects with IPAA performed prior to start of study follow-up included, except left-censored subjects (had first excisional polypectomy post IPAA prior to start of study follow-up). No control group subjects (n=7) had a post-IPAA polypectomy (no data).
Arm/Group Title Matched Celecoxib Treated Matched Control Not Matched Celecoxib Treated All Celecoxib Treated
Hide Arm/Group Description:
Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
Overall Number of Participants Analyzed 3 0 0 3
Mean (Standard Deviation)
Unit of Measure: months
20.3  (15.72) 20.3  (15.72)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Matched Celecoxib Treated
Comments Time to FAP-related surgical events (months); 25th percentile.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Kaplan-Meier Estimate of Time to Event
Estimated Value 11.28
Confidence Interval 95%
9.07 to 38.24
Estimation Comments Kaplan-Meier Estimate of Time to Event (months).
5.Secondary Outcome
Title Time From Most Recent Prior FAP-related Surgical Event or Onset of FAP Phenotype to Time of First Excisional or Ablational Event for Rectal, Colonic, Pouch, or Duodenal Adenomas (Duodenal Adenomatous Polyps)
Hide Description Time (months): [date of first excisional or ablational event for colonic, pouch, or duodenal adenomas occuring after date of most recent prior FAP-related surgical event or date of FAP diagnosis minus date of most recent prior FAP-related surgical event or date of FAP diagnosis plus 1] divided by 30.44.
Time Frame Up to 15 years prior to baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible subjects; first excisional or ablational event for rectal adenomas that does not qualify for primary efficacy endpoint; after most recent FAP-related surgical event prior to start of study follow-up or onset of FAP phenotype for subjects with no prior FAP-related surgery.
Arm/Group Title Matched Celecoxib Treated Matched Control Not Matched Celecoxib Treated All Celecoxib Treated
Hide Arm/Group Description:
Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
Overall Number of Participants Analyzed 8 8 33 41
Mean (Standard Deviation)
Unit of Measure: months
25.7  (18.71) 47.7  (42.32) 89.9  (89.34) 77.4  (84.32)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Matched Celecoxib Treated
Comments Time to FAP-related surgical events (months); 25th percentile.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Kaplan-Meier Estimate of Time to Event
Estimated Value 20.63
Confidence Interval 95%
8.05 to 48.03
Estimation Comments Kaplan-Meier Estimate of Time to Event (months).
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Matched Control
Comments Time to FAP-related surgical events (months); 25th percentile.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Kaplan-Meier Estimate of Time to Event
Estimated Value 40.21
Confidence Interval 95%
8.31 to 105.68
Estimation Comments Kaplan-Meier Estimate of Time to Event (months).
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Not Matched Celecoxib Treated
Comments Time to FAP-related surgical events (months); 25th percentile.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Kaplan-Meier Estimate of Time to Event
Estimated Value 19.81
Confidence Interval 95%
16.03 to 56.34
Estimation Comments Kaplan-Meier Estimate of Time to Event (months).
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection All Celecoxib Treated
Comments Time to FAP-related surgical events (months); 25th percentile.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Kaplan-Meier Estimate of Time to Event
Estimated Value 20.22
Confidence Interval 95%
12.35 to 40.31
Estimation Comments Kaplan-Meier Estimate of Time to Event (months).
6.Secondary Outcome
Title Time From Start of Study Follow-up to Time of First Excisional or Ablational Event for Rectal, Colonic, Pouch, or Duodenal Adenomas
Hide Description Time (months): [date of first excisional or ablational event for colonic, pouch, or duodenal adenomas, occurring after date of most recent prior FAP-related surgical event, or date of FAP diagnosis minus date of start of study follow-up plus 1] divided by 30.44.
Time Frame Baseline, Up to 60 months post-baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible subjects included, except left censored subjects (had any excisional or ablational event for rectal, colonic, pouch, or duodenal adenomas between date of most recent FAP-related surgical event performed prior to the start of study follow-up, or onset of FAP phenotype [with no prior FAP-related surgery], and start of study follow-up).
Arm/Group Title Matched Celecoxib Treated Matched Control Not Matched Celecoxib Treated All Celecoxib Treated
Hide Arm/Group Description:
Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
Overall Number of Participants Analyzed 2 3 3 5
Mean (Standard Deviation)
Unit of Measure: months
0.0  (0.0) 41.7  (21.73) 21.4  (22.39) 12.9  (19.71)
7.Secondary Outcome
Title Time From Most Recent Prior FAP-related Surgical Event or Onset of FAP Phenotype to Time of First FAP-related Adverse Event
Hide Description Time (months): [date of first FAP-related adverse event, occurring after the date of most recent prior FAP-related surgery, or date of FAP diagnosis minus date of most recent prior FAP-related surgery, or date of FAP diagnosis plus 1] divided by 30.44. FAP-related adverse event defined as any FAP related cancers, desmoid tumors requiring procedural intervention, hospitalizations or procedural interventions, or death related to FAP (i.e., as a consequence of FAP, FAP complications, or a procedure or drug used to treat FAP-related medical problems).
Time Frame Up to 15 years prior to baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible subjects; first FAP-related adverse event (FAP-related cancers, desmoid tumors requiring procedural intervention, hospitalizations, procedural interventions, or death related to FAP) after subject's most recent FAP-related surgical event performed prior to start of study follow-up, onset of FAP phenotype (no prior FAP-related surgery).
Arm/Group Title Matched Celecoxib Treated Matched Control Not Matched Celecoxib Treated All Celecoxib Treated
Hide Arm/Group Description:
Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
Overall Number of Participants Analyzed 5 6 30 35
Median (Full Range)
Unit of Measure: months
3.0
(0.2 to 167.0)
3.4
(2.5 to 123.8)
61.4
(1.1 to 362.9)
56.3
(0.2 to 362.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Not Matched Celecoxib Treated
Comments Time to FAP-related events (months); 25th percentile.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Kaplan-Meier Estimate of Time to Event
Estimated Value 21.22
Confidence Interval 95%
4.07 to 64.16
Estimation Comments Kaplan-Meier Estimate of Time to Event (months).
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection All Celecoxib Treated
Comments Time to FAP-related events (months); 25th percentile.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Kaplan-Meier Estimate of Time to Event
Estimated Value 19.81
Confidence Interval 95%
3.68 to 64.16
Estimation Comments Kaplan-Meier Estimate of Time to Event (months).
8.Secondary Outcome
Title Time From Start of Study Follow-up to Time of First FAP-related Adverse Event
Hide Description Time (months): [date of first FAP-related adverse event, occurring after the date of the most recent prior FAP-related surgery, or date of FAP diagnosis minus date of start of study follow-up plus 1] divided by 30.44. FAP-related adverse event defined as any FAP related cancers, desmoid tumors requiring procedural intervention, hospitalizations or procedural interventions, or death related to FAP (i.e., as a consequence of FAP, FAP complications, or a procedure or drug used to treat FAP-related medical problems).
Time Frame Baseline, Up to 60 months post-baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible subjects included, except left-censored subjects (had any FAP-related adverse event between the date of most recent FAP-related surgical event performed prior to start of study follow-up, or onset of FAP phenotype (no prior FAP-related surgery), and start of study follow-up.
Arm/Group Title Matched Celecoxib Treated Matched Control Not Matched Celecoxib Treated All Celecoxib Treated
Hide Arm/Group Description:
Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
Overall Number of Participants Analyzed 1 1 7 8
Median (Full Range)
Unit of Measure: months
37.9
(37.9 to 37.9)
75.7
(75.7 to 75.7)
9.7
(0.8 to 37.7)
14.3
(0.8 to 37.9)
9.Secondary Outcome
Title Time From Post IRA to Time of Conversion From IRA to IPAA
Hide Description Time (months): [date of IPAA minus date of prior IRA plus 1] divided by 30.44.
Time Frame Up to 15 years prior to baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible subjects with IRA performed prior to start of study follow-up; data censored (n=5) for control group subjects (no data).
Arm/Group Title Matched Celecoxib Treated Matched Control Not Matched Celecoxib Treated All Celecoxib Treated
Hide Arm/Group Description:
Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
Overall Number of Participants Analyzed 1 0 9 10
Median (Full Range)
Unit of Measure: months
301.6
(301.6 to 301.6)
129.7
(8.0 to 362.9)
175.8
(8.0 to 362.9)
10.Secondary Outcome
Title Time From Start of Study Follow-up to Time of Conversion From IRA to IPAA
Hide Description Time (months): [date of IPAA minus date of start of study follow-up plus 1] divided by 30.44.
Time Frame Baseline, Up to 60 months post-baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible subjects with IRA performed prior to start of study follow-up included, except left-censored subjects (had IPAA prior to start of study follow-up); data censored (n=5) for control group subjects (no data).
Arm/Group Title Matched Celecoxib Treated Matched Control Not Matched Celecoxib Treated All Celecoxib Treated
Hide Arm/Group Description:
Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
Overall Number of Participants Analyzed 0 0 2 2
Median (Full Range)
Unit of Measure: months
4.8
(0.0 to 9.7)
4.8
(0.0 to 9.7)
11.Secondary Outcome
Title Duodenal Adenoma Burden as Measured by Spigelman Stage
Hide Description Number of subjects with polyp burden as assessed in most recent prior polyps evaluation: Spigelman stage provides index of disease severity based on number of polyps, polyp size, histology, and dysplasia; range is Stage 0 (none) to Stage IV (severe). EOS: endoscopic examination closest to end of on-study celecoxib or index period (within 6 months of end of celecoxib or index period and prior to intake of any exclusionary medications after baseline). Spigelman Stage not completed as staging data largely missing; see measure: Duodenal adenoma burden as measured by polyp counts.
Time Frame Baseline, 6 to 14 months post-baseline, End of study (EOS)
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Hide Analysis Population Description
All subjects; Spigelman Stage not completed as staging data largely missing.
Arm/Group Title Matched Celecoxib Treated Matched Control Not Matched Celecoxib Treated All Celecoxib Treated
Hide Arm/Group Description:
Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Rectal or Pouch Adenoma Burden Based on Polyp Counts
Hide Description Number of subjects with polyp burden as assessed in most recent prior polyps evaluation: attenuated: <100 polyps, mild: between 100 to 1000 polyps, severe: >1000 polyps. EOS: endoscopic examination closest to end of on-study celecoxib or index period (within 6 months of end of celecoxib or index period and prior to intake of any exclusionary medications after baseline).
Time Frame Baseline, 6 to 14 months post-baseline, EOS
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects; duodenal polyp burden analyzed in terms of severity categories and based on polyp numbers.
Arm/Group Title Matched Celecoxib Treated Matched Control Not Matched Celecoxib Treated All Celecoxib Treated
Hide Arm/Group Description:
Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
Overall Number of Participants Analyzed 13 13 41 54
Measure Type: Number
Unit of Measure: particpants
Baseline attenuated 9 4 18 27
Baseline mild 2 2 2 4
Baseline severe 0 0 0 0
Baseline unknown 1 0 12 13
Baseline no polyps 1 6 4 5
Baseline not assessed 0 1 5 5
Post-baseline attenuated 6 3 10 16
Post-baseline mild 0 0 1 1
Post-baseline severe 0 0 0 0
Post-baseline unknown 0 0 0 0
Post-baseline no polyps 4 5 1 5
Post-baseline not assessed 3 5 29 32
EOS attenuated 8 2 12 20
EOS mild 0 0 0 0
EOS severe 0 0 0 0
EOS unknown 3 0 1 4
EOS no polyps 2 6 2 4
EOS not assessed 0 5 26 26
13.Post-Hoc Outcome
Title Duodenal Adenoma Burden as Measured by Polyp Counts
Hide Description Number of subjects with polyp burden as assessed in most recent prior polyps evaluation: attenuated: <100 polyps, mild: between 100 to 1000 polyps, severe: >1000 polyps. EOS: endoscopic examination closest to end of on-study celecoxib or index period (within 6 months of end of celecoxib or index period and prior to intake of any exclusionary medications after baseline). Post-hoc analysis of duodenal polyp burden in terms of severity categories and based on polyp numbers; Spigelman Stage not completed as staging data largely missing (see: Duodenal adenoma burden as measured by Spigelman Stage)
Time Frame Baseline, 6 to 14 months post-baseline, End of study (EOS)
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects; Spigelman Stage not completed as staging data largely missing; duodenal polyp burden analyzed in terms of severity categories and based on polyp numbers.
Arm/Group Title Matched Celecoxib Treated Matched Control Not Matched Celecoxib Treated All Celecoxib Treated
Hide Arm/Group Description:
Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
Overall Number of Participants Analyzed 13 13 41 54
Measure Type: Number
Unit of Measure: participants
Baseline attenuated 5 1 18 23
Baseline mild 0 0 0 0
Baseline severe 0 0 0 0
Baseline unknown 3 2 10 13
Baseline no polyps 1 5 5 6
Baseline not assessed 4 5 8 12
Post-baseline attenuated 1 3 12 13
Post-baseline mild 0 0 0 0
Post-baseline severe 0 0 0 0
Post-baseline unknown 3 0 0 3
Post-baseline no polyps 1 3 0 1
Post-baseline not assessed 8 7 29 37
EOS attenuated 2 2 17 19
EOS mild 0 0 0 0
EOS severe 0 0 0 0
EOS unknown 1 0 2 3
EOS no polyps 1 1 2 3
EOS not assessed 9 10 20 29
Time Frame Up to 15 years prior to baseline; up to 5 years post-baseline. No safety information actively searched for among celecoxib-treated subjects for retrospectively collected data (medical records); if serious adverse event (SAE) found, it was reported as SAE.
Adverse Event Reporting Description All SAEs, expected and unexpected, occurring while subject was receiving celecoxib during his/her prospective (on-study) participation in the study, regardless of the apparent relationship to the drug, were collected and reported to the sponsor. Not applicable to Matched Control subjects n=13; SAEs not collected if no celecoxib treatment received.
 
Arm/Group Title All Celecoxib Treated
Hide Arm/Group Description All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
All-Cause Mortality
All Celecoxib Treated
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
All Celecoxib Treated
Affected / at Risk (%)
Total   5/54 (9.26%) 
Gastrointestinal disorders   
Abdominal pain  1  1/54 (1.85%) 
Abdominal pain upper  2  1/54 (1.85%) 
Duodenal perforation  2  1/54 (1.85%) 
Pancreatitis chronic  2  1/54 (1.85%) 
Musculoskeletal and connective tissue disorders   
Back pain  2  1/54 (1.85%) 
Skin and subcutaneous tissue disorders   
Rash  2  1/54 (1.85%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA v11.1
2
Term from vocabulary, MedDRA (11.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Celecoxib Treated
Affected / at Risk (%)
Total   0/54 (0.00%) 
Study prematurely discontinued May 2008 prior to reaching enrollment target; due to limited number of matched pairs, results do not provide sufficient data to evaluate effectiveness of celecoxib. Last subject last visit was November 2008.
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.
Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
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Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.govCallCenter@pfizer.com
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00151476     History of Changes
Other Study ID Numbers: NQ4-00-02-012
A3191167
First Submitted: September 7, 2005
First Posted: September 9, 2005
Results First Submitted: November 19, 2009
Results First Posted: March 4, 2010
Last Update Posted: March 9, 2010