Colorectal AdenomaPhase 3PRESAPNCT00141193
Prevention of Colorectal Sporadic Adenomatous Polyps (PRESAP)
A Phase 3 study testing Celecoxib in people with Colorectal Adenoma, run by Pfizer at 106 sites in 32 countries.
Trial summary
This study is a prospective, randomized, double-blind, placebo-controlled, multi-center trial to compare the efficacy and safety of celecoxib 400mg QD versus placebo in reducing the occurrence of new colorectal adenomas post-polypectomy at Month 13 (Year 1) and Month 37 (Year 3) of study drug administration. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Colorectal Adenoma
- What is being tested?
- Celecoxib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,561 participants
- Where
- 106 sitesin 32 countries
- Study dates
- Feb 2001to May 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject has had a documented colonoscopy to the cecum performed by a study-related physician with adequate preparation resulting in diagnosis and clearance of an adenomatous polyp(s) within 4 months prior to randomization.
- The subject is willing to abstain from chronic use of all NSAIDs or COX-2 inhibitors excluding aspirin at cardioprotective doses for the duration of the study.
Who cannot join
- The subject has a history of Familial Adenomatous Polyposis or Hereditary Non-Polyposis Colorectal Cancer.
- The subject has a history of inflammatory bowel disease.
Trial locations and contacts
106 sites in 32 countries.
106 sites in 32 countries
United States10 sites
Pfizer Investigational Site
Baltimore, Maryland, 21229
Pfizer Investigational Site
Baltimore, Maryland
Pfizer Investigational Site
Houston, Texas, 77030
Pfizer Investigational Site
North Chicago, Illinois, 60064
Pfizer Investigational Site
Oak Park, Illinois, 60304
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19107-5244
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19107
Pfizer Investigational Site
Richmond, Virginia, 23249
Pfizer Investigational Site
San Diego, California, 92123
Pfizer Investigational Site
San Kiego, California, 92123
Germany10 sites
Pfizer Investigational Site
Berlin, 13353
Pfizer Investigational Site
Erlangen, 91052
Pfizer Investigational Site
Freising, 85356
Pfizer Investigational Site
Hamburg
Pfizer Investigational Site
Künzing, 94550
Pfizer Investigational Site
Ludwigshafen, 67063
Pfizer Investigational Site
Marburg, 35055
Pfizer Investigational Site
München, 81669
Pfizer Investigational Site
München, 81675
Pfizer Investigational Site
Ulm, 89081
Israel8 sites
Pfizer Investigational Site
Beer-Sheeva, 84101
Pfizer Investigational Site
Hadera, 38100
Pfizer Investigational Site
Haifa
Pfizer Investigational Site
Hashomer, 52621
Pfizer Investigational Site
Holon, 58100
Pfizer Investigational Site
Jerusalem, 91120
Pfizer Investigational Site
Petah Tikva
Pfizer Investigational Site
Tel Aviv, 64239
Canada7 sites
Pfizer Investigational Site
Abbotsford British Columbia, British Columbia, V2S 3N5
Pfizer Investigational Site
Edmonton, Alberta, T6G 2B7
Pfizer Investigational Site
Kingston, Ontario, K7L 5G2
Pfizer Investigational Site
London, Ontario, N6A 4G5
Pfizer Investigational Site
St. John's, A1B 3V6
Pfizer Investigational Site
Vancouver, British Columbia, V5Z 1J3
Pfizer Investigational Site
Vancouver, British Columbia, V6Z 1Y6
Czechia7 sites
Pfizer Investigational Site
Brno
Pfizer Investigational Site
Hradec Králové, 500 12
Pfizer Investigational Site
Liberec, 460 63
Pfizer Investigational Site
Prague, 10034
Pfizer Investigational Site
Prague, 11833
Pfizer Investigational Site
Prague, 16 02
Pfizer Investigational Site
Prague
Italy6 sites
Pfizer Investigational Site
Brescia, 25123
Pfizer Investigational Site
Milan, 20141
Pfizer Investigational Site
Roma, 00144
Pfizer Investigational Site
Roma, 00153
Pfizer Investigational Site
San Giovanni Rotondo, Italy/Foggia/Italy, 71013
Pfizer Investigational Site
Siena, 53100
Russia6 sites
Pfizer Investigational Site
Moscow, 103006
Pfizer Investigational Site
Moscow, 113093
Pfizer Investigational Site
Moscow, 115478
Pfizer Investigational Site
Moscow, 117415
Pfizer Investigational Site
Moscow, 123154
Pfizer Investigational Site
Moscow, 129356
Spain5 sites
Pfizer Investigational Site
Barcelona, Barcelona, 08036
Pfizer Investigational Site
Donostia / San Sebastian, Guipuzcoa, 20014
Pfizer Investigational Site
Oviedo, Principality of Asturias, 33006
Pfizer Investigational Site
Palma de Mallorca, Balearic Islands, 07014
Pfizer Investigational Site
Seville, Sevilla, 41071
Belgium4 sites
Pfizer Investigational Site
Brussels, 1070
Pfizer Investigational Site
Brussels, 1090
Pfizer Investigational Site
Brussels, 1200
Pfizer Investigational Site
Ghent, 9000
France4 sites
Pfizer Investigational Site
Bobigny, 93009
Pfizer Investigational Site
Lyon, 69008
Pfizer Investigational Site
Marseille, 13274
Pfizer Investigational Site
Paris, 75679
South Africa4 sites
Pfizer Investigational Site
Cape Town, Western, 7708
Pfizer Investigational Site
Johannesburg, Gauteng, 2157
Pfizer Investigational Site
Johannesburg, Gauteng, 2193
Pfizer Investigational Site
Johannesburg, Gauteng
United Kingdom4 sites
Pfizer Investigational Site
Glasgow, G40SF
Pfizer Investigational Site
Harrow, Middlesex, HA1 3UJ
Pfizer Investigational Site
Newport, Gwent, NP9 2UB
Pfizer Investigational Site
Oxford, OX3 9DU
Uruguay3 sites
Pfizer Investigational Site
Montevideo, 11600
Pfizer Investigational Site
Montevideo, 1200
Pfizer Investigational Site
Montevideo
Australia2 sites
Pfizer Investigational Site
Geelong, Victoria, 3219
Pfizer Investigational Site
Townsville, Queensland, 4812
Brazil2 sites
Pfizer Investigational Site
Porto Alegre, Rio Grande do Sul, 90035-003
Pfizer Investigational Site
São Paulo, São Paulo, 01509-900
China2 sites
Pfizer Investigational Site
Beijing, 10053
Pfizer Investigational Site
Beijing, 100730
Hong Kong2 sites
Pfizer Investigational Site
Hong Kong
Pfizer Investigational Site
New Territories
Hungary2 sites
Pfizer Investigational Site
Győr, 9023
Pfizer Investigational Site
Szekszárd, 7100
Ireland2 sites
Pfizer Investigational Site
Dublin
Pfizer Investigational Site
Wilton, Cork
Singapore2 sites
Pfizer Investigational Site
Singapore, 119074
Pfizer Investigational Site
Singapore, 529889
Slovakia2 sites
Pfizer Investigational Site
Bratislava, 85107
Pfizer Investigational Site
Bratislava
Sweden2 sites
Pfizer Investigational Site
Stockholm, 116 91 Stockholm
Pfizer Investigational Site
Uppsala, 75185 Uppala
About this study
Official title: Clinical Protocol For a Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Celecoxib (SC-58635) In The Prevention of Colorectal Sporadic Adenomatous Polyps (PRESAP)
This study is a prospective, randomized, double-blind, placebo-controlled, multi-center trial to compare the efficacy and safety of celecoxib 400mg QD versus placebo in reducing the occurrence of new colorectal adenomas post-polypectomy at Month 13 (Year 1) and Month 37 (Year 3) of study drug administration.
- Conditions
- Colorectal Adenoma
- Being tested
- Celecoxib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelecoxibDrug
| Study group | Role | What they receive |
|---|---|---|
| A | Placebo comparator | Not described Receives: Drug: Celecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effects of celecoxib in reducing the proportion of subjects with new colorectal adenomas post baseline polypectomy after Month 13 (Year 1) and Month 37 (Year 3) of study drug administration.
Measured: 3 years
Secondary outcomes (3)
The number of colorectal adenomas in study subjects
Measured: 3 years
the histopathologic grade of colorectal adenomas
Measured: 3 years
the size of colorectal adenomas measured after one year and three years of study drug use.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2005 (estimated)
- Study startFeb 2001
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Colorectal AdenomaStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,561 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00141193
- Sponsor's protocol ID
- EQ4-00-02-018
- Other IDs
- A3191107
- Acronym
- PRESAP
- Status last verified
- Aug 2008
- First submitted
- 30 Aug 2005
- Last updated
- 6 Aug 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Arber N, Lieberman D, Wang TC, Zhang R, Sands GH, Bertagnolli MM, Hawk ET, Eagle C, Coindreau J, Zauber A, Lanas A, Levin B. The APC and PreSAP trials: a post hoc noninferiority analysis using a comprehensive new measure for gastrointestinal tract injury in 2 randomized, double-blind studies comparing celecoxib and placebo. Clin Ther. 2012 Mar;34(3):569-79. doi: 10.1016/j.clinthera.2012.02.001. Epub 2012 Mar 2.
PubMed 22386831Arber N, Spicak J, Racz I, Zavoral M, Breazna A, Gerletti P, Lechuga MJ, Collins N, Rosenstein RB, Eagle CJ, Levin B. Five-year analysis of the prevention of colorectal sporadic adenomatous polyps trial. Am J Gastroenterol. 2011 Jun;106(6):1135-46. doi: 10.1038/ajg.2011.116. Epub 2011 Apr 19.
PubMed 21503000Solomon SD, Wittes J, Finn PV, Fowler R, Viner J, Bertagnolli MM, Arber N, Levin B, Meinert CL, Martin B, Pater JL, Goss PE, Lance P, Obara S, Chew EY, Kim J, Arndt G, Hawk E; Cross Trial Safety Assessment Group. Cardiovascular risk of celecoxib in 6 randomized placebo-controlled trials: the cross trial safety analysis. Circulation. 2008 Apr 22;117(16):2104-13. doi: 10.1161/CIRCULATIONAHA.108.764530. Epub 2008 Mar 31.
PubMed 18378608Arber N, Eagle CJ, Spicak J, Racz I, Dite P, Hajer J, Zavoral M, Lechuga MJ, Gerletti P, Tang J, Rosenstein RB, Macdonald K, Bhadra P, Fowler R, Wittes J, Zauber AG, Solomon SD, Levin B; PreSAP Trial Investigators. Celecoxib for the prevention of colorectal adenomatous polyps. N Engl J Med. 2006 Aug 31;355(9):885-95. doi: 10.1056/NEJMoa061652.
PubMed 16943401Solomon SD, Pfeffer MA, McMurray JJ, Fowler R, Finn P, Levin B, Eagle C, Hawk E, Lechuga M, Zauber AG, Bertagnolli MM, Arber N, Wittes J; APC and PreSAP Trial Investigators. Effect of celecoxib on cardiovascular events and blood pressure in two trials for the prevention of colorectal adenomas. Circulation. 2006 Sep 5;114(10):1028-35. doi: 10.1161/CIRCULATIONAHA.106.636746.
PubMed 16943394
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Protocol For a Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Celecoxib (SC-58635) In The Prevention of Colorectal Sporadic Adenomatous Polyps (PRESAP)
- ClinicalTrials.gov ID
- NCT00141193
- Acronym / sponsor ID
- PRESAP / EQ4-00-02-018
- Conditions
- Colorectal Adenoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,561 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 2001
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 1 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a prospective, randomized, double-blind, placebo-controlled, multi-center trial to compare the efficacy and safety of celecoxib 400mg QD versus placebo in reducing the occurrence of new colorectal adenomas post-polypectomy at Month 13 (Year 1) and Month 37 (Year 3) of study drug administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Placebo comparator | Drug: Celecoxib |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The subject has had a documented colonoscopy to the cecum performed by a study-related physician with adequate preparation resulting in diagnosis and clearance of an adenomatous polyp(s) within 4 months prior to randomization.
- The subject is willing to abstain from chronic use of all NSAIDs or COX-2 inhibitors excluding aspirin at cardioprotective doses for the duration of the study.
Key exclusion criteria (2 listed)
- The subject has a history of Familial Adenomatous Polyposis or Hereditary Non-Polyposis Colorectal Cancer.
- The subject has a history of inflammatory bowel disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Celecoxib | Drug | A |
Primary outcome
To evaluate the effects of celecoxib in reducing the proportion of subjects with new colorectal adenomas post baseline polypectomy after Month 13 (Year 1) and Month 37 (Year 3) of study drug administration.
Time frame: 3 years
3 secondary outcomes
The number of colorectal adenomas in study subjects
Time frame: 3 years
the histopathologic grade of colorectal adenomas
Time frame: 3 years
the size of colorectal adenomas measured after one year and three years of study drug use.
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2008.
- Derived from this study: PubMed 22386831Arber N, Lieberman D, Wang TC, Zhang R, Sands GH, Bertagnolli MM, Hawk ET, Eagle C, Coindreau J, Zauber A, Lanas A, Levin B. The APC and PreSAP trials: a post hoc noninferiority analysis using a comprehensive new measure for gastrointestinal tract injury in 2 randomized, double-blind studies comparing celecoxib and placebo. Clin Ther. 2012 Mar;34(3):569-79. doi: 10.1016/j.clinthera.2012.02.001. Epub 2012 Mar 2.
- Derived from this study: PubMed 21503000Arber N, Spicak J, Racz I, Zavoral M, Breazna A, Gerletti P, Lechuga MJ, Collins N, Rosenstein RB, Eagle CJ, Levin B. Five-year analysis of the prevention of colorectal sporadic adenomatous polyps trial. Am J Gastroenterol. 2011 Jun;106(6):1135-46. doi: 10.1038/ajg.2011.116. Epub 2011 Apr 19.
- Derived from this study: PubMed 18378608Solomon SD, Wittes J, Finn PV, Fowler R, Viner J, Bertagnolli MM, Arber N, Levin B, Meinert CL, Martin B, Pater JL, Goss PE, Lance P, Obara S, Chew EY, Kim J, Arndt G, Hawk E; Cross Trial Safety Assessment Group. Cardiovascular risk of celecoxib in 6 randomized placebo-controlled trials: the cross trial safety analysis. Circulation. 2008 Apr 22;117(16):2104-13. doi: 10.1161/CIRCULATIONAHA.108.764530. Epub 2008 Mar 31.
- Derived from this study: PubMed 16943401Arber N, Eagle CJ, Spicak J, Racz I, Dite P, Hajer J, Zavoral M, Lechuga MJ, Gerletti P, Tang J, Rosenstein RB, Macdonald K, Bhadra P, Fowler R, Wittes J, Zauber AG, Solomon SD, Levin B; PreSAP Trial Investigators. Celecoxib for the prevention of colorectal adenomatous polyps. N Engl J Med. 2006 Aug 31;355(9):885-95. doi: 10.1056/NEJMoa061652.
- Derived from this study: PubMed 16943394Solomon SD, Pfeffer MA, McMurray JJ, Fowler R, Finn P, Levin B, Eagle C, Hawk E, Lechuga M, Zauber AG, Bertagnolli MM, Arber N, Wittes J; APC and PreSAP Trial Investigators. Effect of celecoxib on cardiovascular events and blood pressure in two trials for the prevention of colorectal adenomas. Circulation. 2006 Sep 5;114(10):1028-35. doi: 10.1161/CIRCULATIONAHA.106.636746.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
106 sites in 32 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Celecoxib in people with Colorectal Adenoma, run by Pfizer at 106 sites in 32 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 106 sites in United States, Germany, Israel, Canada, Czechia and 27 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the effects of celecoxib in reducing the proportion of subjects with new colorectal adenomas post baseline polypectomy after Month 13 (Year 1) and Month 37 (Year 3) of study drug administration. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00141193, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2008.