Trial · NCT00151476
Observational Familial Adenomatous Polyposis Registry Study In Patients Receiving Celecoxib Compared to Control Patients
NCT00151476, Terminated, Pfizer; results first posted 2010-03-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Observational Familial Adenomatous Polyposis Registry Study In Patients Receiving Celecoxib Compared to Control Patients. Trials, record NCT00151476. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00151476
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Observational Familial Adenomatous Polyposis Registry Study In Patients Receiving Celecoxib Compared to Control Patients
- NCT number
- NCT00151476
- Status
- Terminated
- Enrollment
- 68 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Familial Adenomatous Polyposis (FAP)
- Interventions
- Celecoxib, Routine Medical Care
- First posted
- 2005-09-09
- Last updated
- 2024-09-04
- Results first posted
- 2010-03-04
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time From Ileorectal Anastomosis (IRA) to Time of First Excisional Polypectomy of a Rectal Polyp Post IRA | Up to 8 years prior to baseline | 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. |
| Primary | Time From Start of Study Follow-up to the Time of First Excisional Polypectomy of a Rectal Polyp Post IRA | Baseline, Up to 60 months post-baseline | 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. |
| Primary | Time From Ileopouch Anal Anastomosis (IPAA) to Time of First Excisional Polypectomy of a Rectal Polyp Post IPAA | Up to 15 years prior to baseline | 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. |
| Primary | Time From Start of Study Follow-up to Time of First Excisional Polypectomy of a Rectal Polyp Post IPAA | Baseline, Up to 60 months post-baseline | 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. |
| Secondary | 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) | Up to 15 years prior to baseline | 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. |
| Secondary | Time From Start of Study Follow-up to Time of First Excisional or Ablational Event for Rectal, Colonic, Pouch, or Duodenal Adenomas | Baseline, Up to 60 months post-baseline | 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. |
| Secondary | Time From Most Recent Prior FAP-related Surgical Event or Onset of FAP Phenotype to Time of First FAP-related Adverse Event | Up to 15 years prior to baseline | 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). |
| Secondary | Time From Start of Study Follow-up to Time of First FAP-related Adverse Event | Baseline, Up to 60 months post-baseline | 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). |
| Secondary | Time From Post IRA to Time of Conversion From IRA to IPAA | Up to 15 years prior to baseline | Time (months): \[date of IPAA minus date of prior IRA plus 1\] divided by 30.44. |
| Secondary | Time From Start of Study Follow-up to Time of Conversion From IRA to IPAA | Baseline, Up to 60 months post-baseline | Time (months): \[date of IPAA minus date of start of study follow-up plus 1\] divided by 30.44. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time From Ileorectal Anastomosis (IRA) to Time of First Excisional Polypectomy of a Rectal Polyp Post IRA | Up to 8 years prior to baseline | 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. | months | MEAN |
| PRIMARY | Time From Start of Study Follow-up to the Time of First Excisional Polypectomy of a Rectal Polyp Post IRA | Baseline, Up to 60 months post-baseline | 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). | months | MEDIAN |
| PRIMARY | Time From Ileopouch Anal Anastomosis (IPAA) to Time of First Excisional Polypectomy of a Rectal Polyp Post IPAA | Up to 15 years prior to baseline | 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). | months | MEAN |
| PRIMARY | Time From Start of Study Follow-up to Time of First Excisional Polypectomy of a Rectal Polyp Post IPAA | Baseline, Up to 60 months post-baseline | 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). | months | MEAN |
| SECONDARY | 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) | Up to 15 years prior to baseline | 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. | months | MEAN |
| SECONDARY | Time From Start of Study Follow-up to Time of First Excisional or Ablational Event for Rectal, Colonic, Pouch, or Duodenal Adenomas | Baseline, Up to 60 months post-baseline | 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). | months | MEAN |
| SECONDARY | Time From Most Recent Prior FAP-related Surgical Event or Onset of FAP Phenotype to Time of First FAP-related Adverse Event | Up to 15 years prior to baseline | 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). | months | MEDIAN |
| SECONDARY | Time From Start of Study Follow-up to Time of First FAP-related Adverse Event | Baseline, Up to 60 months post-baseline | 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. | months | MEDIAN |
| SECONDARY | Time From Post IRA to Time of Conversion From IRA to IPAA | Up to 15 years prior to baseline | All eligible subjects with IRA performed prior to start of study follow-up; data censored (n=5) for control group subjects (no data). | months | MEDIAN |
| SECONDARY | Time From Start of Study Follow-up to Time of Conversion From IRA to IPAA | Baseline, Up to 60 months post-baseline | 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). | months | MEDIAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group176
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time From Ileorectal Anastomosis (IRA) to Time of First Excisional Polypectomy of a Rectal Polyp Post IRA | Matched Celecoxib Treated | 86.4 | Standard Deviation 143.78 | months | |
| Time From Ileorectal Anastomosis (IRA) to Time of First Excisional Polypectomy of a Rectal Polyp Post IRA | Matched Control | 4.0 | Standard Deviation 3.25 | months | |
| Time From Ileorectal Anastomosis (IRA) to Time of First Excisional Polypectomy of a Rectal Polyp Post IRA | Not Matched Celecoxib Treated | 78.4 | Standard Deviation 102.01 | months | |
| Time From Ileorectal Anastomosis (IRA) to Time of First Excisional Polypectomy of a Rectal Polyp Post IRA | All Celecoxib Treated | 79.5 | Standard Deviation 105.44 | months | |
| Time From Start of Study Follow-up to the Time of First Excisional Polypectomy of a Rectal Polyp Post IRA | Matched Celecoxib Treated | 19.8 | Full Range 17.14 | months | |
| Time From Start of Study Follow-up to the Time of First Excisional Polypectomy of a Rectal Polyp Post IRA | Not Matched Celecoxib Treated | 32.1 | Full Range 0.0 to 44.1 | months | |
| Time From Start of Study Follow-up to the Time of First Excisional Polypectomy of a Rectal Polyp Post IRA | All Celecoxib Treated | 25.9 | Full Range 0.0 to 44.1 | months | |
| Time From Ileopouch Anal Anastomosis (IPAA) to Time of First Excisional Polypectomy of a Rectal Polyp Post IPAA | Matched Celecoxib Treated | 152.7 | Standard Deviation 42.10 | months | |
| Time From Ileopouch Anal Anastomosis (IPAA) to Time of First Excisional Polypectomy of a Rectal Polyp Post IPAA | All Celecoxib Treated | 152.7 | Standard Deviation 42.10 | months | |
| Time From Start of Study Follow-up to Time of First Excisional Polypectomy of a Rectal Polyp Post IPAA | Matched Celecoxib Treated | 20.3 | Standard Deviation 15.72 | months |
1 to 10 of 176Source ClinicalTrials.gov
See all 176 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| FAP Identified Subjects | STARTED | Matched Control | 13 | |
| FAP Identified Subjects | STARTED | All Celecoxib Treated | 55 | |
| FAP Identified Subjects | COMPLETED | Matched Control | 13 | |
| FAP Identified Subjects | COMPLETED | All Celecoxib Treated | 54 | |
| FAP Identified Subjects | NOT COMPLETED | Matched Control | 0 | |
| FAP Identified Subjects | NOT COMPLETED | All Celecoxib Treated | 1 | |
| FAP Analyzed Subjects | STARTED | Matched Control | 13 | |
| FAP Analyzed Subjects | STARTED | All Celecoxib Treated | 54 | |
| FAP Analyzed Subjects | COMPLETED | Matched Control | 13 | |
| FAP Analyzed Subjects | COMPLETED | All Celecoxib Treated | 51 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Abdominal pain | Gastrointestinal disorders | All Celecoxib Treated | 1 | 54 | |
| serious | Abdominal pain upper | Gastrointestinal disorders | All Celecoxib Treated | 1 | 54 | |
| serious | Duodenal perforation | Gastrointestinal disorders | All Celecoxib Treated | 1 | 54 | |
| serious | Pancreatitis chronic | Gastrointestinal disorders | All Celecoxib Treated | 1 | 54 | |
| serious | Back pain | Musculoskeletal and connective tissue disorders | All Celecoxib Treated | 1 | 54 | |
| serious | Rash | Skin and subcutaneous tissue disorders | All Celecoxib Treated | 1 | 54 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All Celecoxib Treated | ||
| Total, other adverse events | All Celecoxib Treated | 0 | 54 |
| Total, serious adverse events | All Celecoxib Treated | 5 | 54 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00151476
GET https://conductscience.org/api/trials/v1/NCT00151476/results?page=2