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See termination reason in detailed description.
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To test whether celecoxib can be used to prevent colon polyp formation in children with familial adenomatous polyposis (FAP).
Per DMC recommendation, the study was terminated early (31Oct2013) due to low enrollment and low endpoint accumulation rate. No safety concerns were involved in the decision to terminate the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Celecoxib | Experimental | celecoxib, 16 mg/kg/day, for 5 years |
|
| Placebo | Placebo Comparator | Masked, placebo comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celecoxib | Drug | celecoxib, 16 mg/kg/day, for 5 years |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Disease Progression | Time to disease progression was defined as the time from randomization to the earliest occurrence of one or more of the following events:
| 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Treatment Failure | Time to treatment failure was defined as time from randomization to the earliest occurrence of one or more of the following:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Chicago | Illinois | 60612 | United States | ||
| Pfizer Investigational Site |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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The randomization was to be stratified by center, age (≥12 years old versus <12 years old), and familial adenomatous polyposis (FAP) phenotype (negative versus positive). The participants were randomized 1:1 to one of the 2 treatments celecoxib or placebo.
A total of 305 participants were screened, whereof 106 were randomized into the study, and of whom 101 took at least 1 dose of study drug. The clinical study was conducted in 18 centers across 13 countries: Belgium, Czech Republic, Hong Kong, Hungary, Israel, Italy, Slovakia, South Africa, Spain, Sweden, Ukraine, United Kingdom, and United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Celecoxib | Celecoxib, approximately 16 mg/kg/day (adjusted for changes in body weight). Maximum dose was 400 mg twice daily. |
| FG001 | Placebo | Matching placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Placebo | Drug | Masked, placebo comparator |
|
| 5 years |
| Total Number of Colorectal Polyps | Total number of colorectal polyps >2 mm in size, that were detected over Years 1 - 5 cumulatively. Weighted total number of colorectal polyps over Years 1 - 5 cumulatively was defined as the total number of colorectal polyps >2 mm in size, that were detected over Years 1 - 5, divided by the number of colonoscopies that the participant had during the study. | Years 1 - 5 |
| Colorectal Polyp Burden | The polyp burden was defined as the sum of the largest diameters of all polyps (>2 mm in size) over Years 1 - 5 cumulatively. Weighted colorectal polyp burden over Years 1 - 5 cumulatively was defined as the polyp burden over Years 1 - 5 divided by the number of colonoscopies that the participant had during the study. | Years 1 - 5 |
| Ann Arbor |
| Michigan |
| 48109 |
| United States |
| Pfizer Investigational Site | Omaha | Nebraska | 68114 | United States |
| Pfizer Investigational Site | New York | New York | 10017 | United States |
| Pfizer Investigational Site | New York | New York | 10022 | United States |
| Pfizer Investigational Site | New York | New York | 10065 | United States |
| Pfizer Investigational Site | Chagrin Falls | Ohio | 44136 | United States |
| Pfizer Investigational Site | Cincinnati | Ohio | 45229 | United States |
| Pfizer Investigational Site | Cleveland | Ohio | 44122 | United States |
| Pfizer Investigational Site | Cleveland | Ohio | 44195 | United States |
| Pfizer Investigational Site | Elyria | Ohio | 44035 | United States |
| Pfizer Investigational Site | Independence | Ohio | 44131 | United States |
| Pfizer Investigational Site | Lakewood | Ohio | 44107 | United States |
| Pfizer Investigational Site | Lorain | Ohio | 44053 | United States |
| Pfizer Investigational Site | Solon | Ohio | 44138 | United States |
| Pfizer Investigational Site | Strongsville | Ohio | 44136 | United States |
| Pfizer Investigational Site | Westlake | Ohio | 44145 | United States |
| Pfizer Investigational Site | Willoughby Hills | Ohio | 44094 | United States |
| Pfizer Investigational Site | Wooster | Ohio | 44691 | United States |
| Pfizer Investigational Site | Nashville | Tennessee | 37232 | United States |
| Pfizer Investigational Site | Houston | Texas | 77030-4990 | United States |
| Pfizer Investigational Site | Salt Lake City | Utah | 84112 | United States |
| Pfizer Investigational Site | Salt Lake City | Utah | 84132 | United States |
| Pfizer Investigational Site | Brussels | 1200 | Belgium |
| Pfizer Investigational Site | Ghent | 9000 | Belgium |
| Pfizer Investigational Site | Prague | 150 06 | Czechia |
| Pfizer Investigational Site | Shatin | New Territories | 0 | Hong Kong |
| Pfizer Investigational Site | Hong Kong | 150001 | Hong Kong |
| Pfizer Investigational Site | Miskolc | 3501 | Hungary |
| Pfizer Investigational Site | Haifa | 31096 | Israel |
| Pfizer Investigational Site | M.P. Lower Galilee | 15208 | Israel |
| Pfizer Investigational Site | Petach Tikvah 49202 | Israel |
| Pfizer Investigational Site | Tel Aviv | 64239 | Israel |
| Pfizer Investigational Site | Roma | 00144 | Italy |
| Pfizer Investigational Site | Siena | 53100 | Italy |
| Pfizer Investigational Site | Rio Piedras | 00935 | Puerto Rico |
| Pfizer Investigational Site | Bratislava | 833 40 | Slovakia |
| Pfizer Investigational Site | Cape Town | Western Cape, South Africa | 7925 | South Africa |
| Pfizer Investigational Site | Madrid | 28040 | Spain |
| Pfizer Investigational Site | Stockholm | 17176 | Sweden |
| Pfizer Investigational Site | Donetsk | 83052 | Ukraine |
| Pfizer Investigational Site | Harrow, Middlesex | England | HA1 3UJ | United Kingdom |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The intent-to-treat (ITT) population (N: 106) consisted of all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether the participants received any study drug or received a different drug from that to which they were randomized.
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| ID | Title | Description |
|---|---|---|
| BG000 | Celecoxib | Celecoxib, approximately 16 mg/kg/day (adjusted for changes in body weight). Maximum dose was 400 mg twice daily. |
| BG001 | Placebo | Matching placebo |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Disease Progression | Time to disease progression was defined as the time from randomization to the earliest occurrence of one or more of the following events:
| ITT population (N: 106) consisted of all participants who were randomized and assigned to treatment. Primary outcome measure was met by 7 (Polyp:7,ColMal:0) participants in the Celecoxib group and 13 (13,0) in the placebo group. Study was early terminated due to low enrollment and lower than expected endpoint rate. No analysis was performed. | Posted | Mean | Standard Deviation | years | 5 years |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Time to Treatment Failure | Time to treatment failure was defined as time from randomization to the earliest occurrence of one or more of the following:
| ITT population (N: 106) consisted of all participants who were randomized and assigned to treatment. Secondary outcome measure was met by 14 (Polyp:7,ColMal:0,DO:14) participants in the Celecoxib and 14 (13,0,12) in the placebo group. Study was early terminated due to low enrollment and lower than expected endpoint rate. No analysis was performed. | Posted | Mean | Standard Deviation | years | 5 years |
| ||||||||||||||||||||||||||||||
| Secondary | Total Number of Colorectal Polyps | Total number of colorectal polyps >2 mm in size, that were detected over Years 1 - 5 cumulatively. Weighted total number of colorectal polyps over Years 1 - 5 cumulatively was defined as the total number of colorectal polyps >2 mm in size, that were detected over Years 1 - 5, divided by the number of colonoscopies that the participant had during the study. | ITT population (N: 106) consisted of all participants who were randomized and assigned to a treatment. Study was early terminated due to low enrollment and lower than expected endpoint rate and no analysis was performed. | Posted | Mean | Standard Deviation | polyps | Years 1 - 5 |
|
| |||||||||||||||||||||||||||||
| Secondary | Colorectal Polyp Burden | The polyp burden was defined as the sum of the largest diameters of all polyps (>2 mm in size) over Years 1 - 5 cumulatively. Weighted colorectal polyp burden over Years 1 - 5 cumulatively was defined as the polyp burden over Years 1 - 5 divided by the number of colonoscopies that the participant had during the study. | ITT population (N: 106) consisted of all participants who were randomized and assigned to a treatment. Study was early terminated due to low enrollment and lower than expected endpoint rate and no analysis was performed. | Posted | Mean | Standard Deviation | mm | Years 1 - 5 |
|
|
Events were reported from randomization through and including 30 calendar days after the last administration of the study drug.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Celecoxib | Celecoxib, approximately 16 mg/kg/day (adjusted for changes in body weight). Maximum dose was 400 mg twice daily. | 3 | 53 | 36 | 53 | ||
| EG001 | Placebo | Matching placebo | 0 | 48 | 30 | 48 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Periorbital cellulitis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Albumin urine present | Investigations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
|
The study was early terminated and, due to the low number of participants, no efficacy analysis was performed. Only descriptive statistics was performed.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D011125 | Adenomatous Polyposis Coli |
| ID | Term |
|---|---|
| D018256 | Adenomatous Polyps |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009386 | Neoplastic Syndromes, Hereditary |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D044483 | Intestinal Polyposis |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
|
| Units | Counts |
|---|
| Participants |
|
|
|
|