Expired Study
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Cleveland, Ohio 44195


Purpose:

This is a registry-based observational study assessing clinical outcomes in FAP patients receiving celecoxib compared with historical/concurrent registry patients who have not received celecoxib. Both retrospective and prospective data will be utilized. No sampling methods apply.


Study summary:

The study prematurely discontinued on April 11, 2008 due to slow enrollment. It should be noted that safety concerns have not been seen in this study and have not factored into this decision.


Criteria:

Inclusion Criteria: Celecoxib Treated Patients: - Diagnosis of FAP based on the expression of the FAP phenotype. - Celecoxib treatment prescribed outside of a clinical trial setting with expected duration of celecoxib treatment of at least six months. Historical/Concurrent Control Patients: - Diagnosis of FAP based on the expression of the FAP phenotype. - Be greater than or equal to 12 years old at the time of study enrollment. - Have an endoscopically assessable colonic, rectal, ileal pouch and/or gastroduodenal segment. - For the group of post-surgical patients, IRA or IPAA performed from 1985 onward (in order to assure standardized surgical techniques and post-surgical management). Patients whose primary colorectal surgery was performed prior to 1985 will not be eligible to serve as historical controls. Exclusion Criteria: Celecoxib Treated Patients: - Have received a pharmacological treatment (other than celecoxib) within the last 3 months for their FAP disease including treatment of any extracolonic manifestation of FAP. - Have received a non-steroidal anti-inflammatory drug (NSAID) within the last 3 months, other than celecoxib, for any reason. Historical/Concurrent Control Patients: - Have pharmacological treatment recorded for their FAP disease at the defined index date. - Have received a non-steroidal anti-inflammatory drug (NSAID) within the last 3 months for any reason.


Study is Available At:


Original ID:

NQ4-00-02-012


NCT ID:

NCT00151476


Secondary ID:

A3191167


Study Acronym:


Brief Title:

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


Official Title:

A Registry-Based Observational Study Assessing Clinical Outcomes In Familial Adenomatous Polyposis In Patients Receiving Celecoxib (Celebrex(Registered), Onsenal(Registered)) Compared With Control Patients


Overall Status:

Terminated


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

12 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Pfizer


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:

See Detailed Description


Study Type:

Observational


Study Design:

Observational Model: Cohort


Number of Arms:

0


Number of Groups:

2


Total Enrollment:

68


Enrollment Type:

Actual


Overall Contact Information

Official Name:Pfizer CT.gov Call Center
Study Director
Pfizer

Study Dates

Start Date:November 2004
Completion Date:November 2008
Completion Type:Actual
Primary Completion Date:November 2008
Primary Completion Type:Actual
Verification Date:March 2010
Last Changed Date:March 4, 2010
First Received Date:September 7, 2005
First Results Date:November 19, 2009

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Rectal or Pouch Adenoma Burden Based on Polyp Counts
Time Frame:Baseline, 6 to 14 months post-baseline, EOS
Safety Issues:False
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 perio
Outcome Type:Secondary Outcome
Measure:Duodenal Adenoma Burden as Measured by Spigelman Stage
Time Frame:Baseline, 6 to 14 months post-baseline, End of study (EOS)
Safety Issues:False
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:
Outcome Type:Secondary Outcome
Measure:Time From Start of Study Follow-up to Time of Conversion From IRA to IPAA
Time Frame:Baseline, Up to 60 months post-baseline
Safety Issues:False
Description:Time (months): [date of IPAA minus date of start of study follow-up plus 1] divided by 30.44.
Outcome Type:Secondary Outcome
Measure:Time From Post IRA to Time of Conversion From IRA to IPAA
Time Frame:Up to 15 years prior to baseline
Safety Issues:False
Description:Time (months): [date of IPAA minus date of prior IRA plus 1] divided by 30.44.
Outcome Type:Secondary Outcome
Measure:Time From Start of Study Follow-up to Time of First FAP-related Adverse Event
Time Frame:Baseline, Up to 60 months post-baseline
Safety Issues:False
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
Outcome Type:Secondary Outcome
Measure:Time From Most Recent Prior FAP-related Surgical Event or Onset of FAP Phenotype to Time of First FAP-related Adverse Event
Time Frame:Up to 15 years prior to baseline
Safety Issues:False
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. FA
Outcome Type:Secondary Outcome
Measure:Time From Start of Study Follow-up to Time of First Excisional or Ablational Event for Rectal, Colonic, Pouch, or Duodenal Adenomas
Time Frame:Baseline, Up to 60 months post-baseline
Safety Issues:False
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
Outcome Type:Secondary Outcome
Measure: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)
Time Frame:Up to 15 years prior to baseline
Safety Issues:False
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 o
Outcome Type:Primary Outcome
Measure:Time From Start of Study Follow-up to Time of First Excisional Polypectomy of a Rectal Polyp Post IPAA
Time Frame:Baseline, Up to 60 months post-baseline
Safety Issues:False
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.
Outcome Type:Primary Outcome
Measure:Time From Ileopouch Anal Anastomosis (IPAA) to Time of First Excisional Polypectomy of a Rectal Polyp Post IPAA
Time Frame:Up to 15 years prior to baseline
Safety Issues:False
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 compar
Outcome Type:Primary Outcome
Measure:Time From Start of Study Follow-up to the Time of First Excisional Polypectomy of a Rectal Polyp Post IRA
Time Frame:Baseline, Up to 60 months post-baseline
Safety Issues:False
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.
Outcome Type:Primary Outcome
Measure:Time From Ileorectal Anastomosis (IRA) to Time of First Excisional Polypectomy of a Rectal Polyp Post IRA
Time Frame:Up to 8 years prior to baseline
Safety Issues:False
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

Study Interventions

Intervention Type:Drug
Name:Celecoxib
Description:800 mg total daily dosing
Arm Name:Celecoxib - Routine Medical Care
Other Name:celebrex, SC-58635
Intervention Type:Other
Name:Routine Medical Care
Arm Name:Control Group - Routine Medical Care

Study Arms

Study Arm Type:Other
Arm Name:Control Group - Routine Medical Care
Description:Observation of subjects treated with routine medical care
Study Arm Type:Other
Arm Name:Celecoxib - Routine Medical Care
Description:800 mg total daily dosing

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Pfizer

Samples and Retentions

Study Population: Patients with FAP
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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