Familial Adenomatous PolyposisPhase 2/3PreDuoFAPNCT00808743
Prevention of Progression of Duodenal Adenomas in Patients With Familial Adenomatous Polyposis
A Phase 2/3 study testing Celecoxib and Ursodeoxycholic acid in people with Familial Adenomatous Polyposis and Duodenal Neoplasms, run by Radboud University Medical Center at 5 sites in Netherlands.
Trial summary
Duodenal carcinomas are the leading cause of mortality in patients with Familial Adenomatous Polyposis (FAP) who underwent prophylactic colorectal surgery. The purpose of this study is to determine wether celecoxib combined with ursodeoxycholic acid is an effective chemoprevention strategy to influence the progression… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Familial Adenomatous Polyposis, Duodenal Neoplasms, Duodenal Polyps
- What is being tested?
- Celecoxib and Ursodeoxycholic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 5 sitesNetherlands
- Study dates
- May 2009to Jan 2013
- Phase
- Phase 2/3
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Familial adenomatous Polyposis: APC-mutation identified or more than 100 colorectal polyps on diagnosis
- Spigelman score of duodenal adenoma equal to II or III
Who cannot join
- Incapability of signing informed consent
- Active gastric or duodenal ulcer, gastrointestinal bleeding
- Cardiovascular disease or risk:
- Congestive cardiac failure: NYHA class II to IV
- Proven ischemic heart disease and/or cerebrovascular disease
- Risk factors: hypertension, hyperlipidaemia, diabetes mellitus, family history of cardiovascular events (≥2 first degree family members <55 years)
Show all 14Show fewer
- Renal dysfunction: creatinine clearance below 50mL/min
- Liver dysfunction: albumin below 25 g/L or Child-Pugh-score equal to or below 10
- Known allergic reaction to sulfonamides, NSAIDs or ursodeoxycholic acid
- Use of NSAIDs or ursodeoxycholic acid for more than 1 week during the 6 months prior to the start of the study
- Use of lithium
- Symptomatic gallstones
- Inflammatory bowel disease
- (Possible) pregnancy or breast feeding
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Netherlands5 sites
Academic Medical Center
Amsterdam
University Medical Center
Groningen
Leiden University Medical Center
Leiden
University Medical Center St. Radboud
Nijmegen
Erasmus Medical Center
Rotterdam
About this study
Official title: Prevention of Progression of Duodenal Adenomas to Cancer in Patients With Familial Adenomatous Polyposis (FAP)
Duodenal carcinomas are the leading cause of mortality in patients with Familial Adenomatous Polyposis (FAP) who underwent prophylactic colorectal surgery. The purpose of this study is to determine wether celecoxib combined with ursodeoxycholic acid is an effective chemoprevention strategy to influence the progression of duodenal adenomas to carcinomas in patients with FAP.
- Being tested
- Celecoxib, Ursodeoxycholic acid, Placebo
- Keywords
- Familial adenomatous polyposis, Adenomatous Polyposis Coli, Digestive System Neoplasms, Gastrointestinal Disease, Intestinal disease, Intestinal neoplasms, Gastrointestinal neoplasms, Polyps, Adenoma, Adenomatous Polyps, Neoplastic Syndromes, Hereditary, Digestive System Diseases, Genetic Diseases, Inborn, Chemoprevention, Celecoxib, Ursodeoxycholic acid, Anti-Inflammatory agents, Non-Steroidal, Cyclooxygenase Inhibitors
- Medical subject headings
- Adenomatous Polyposis Coli, Duodenal Neoplasms, Digestive System Neoplasms, Gastrointestinal Diseases, Intestinal Diseases, Intestinal Neoplasms, Gastrointestinal Neoplasms, Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelecoxibDrug
Celecoxib: 400mg twice daily, orally, 6 months
Ursodeoxycholic acidDrug
Ursodeoxycholic acid: orally, 6 months, dosage based on body weight:
below 50 kg: 1000mg, divided in two daily doses; 50-70 kg: 1500mg, divided in two daily doses; over 70 kg: 2000mg, divided in two daily doses
PlaceboDrug
Placebo: orally, 6 months, dosage based on body weight:
below 50 kg: 1000mg, divided in two daily doses; 50-70 kg: 1500mg, divided in two daily doses; over 70 kg: 2000mg, divided in two daily doses
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Patients receive oral celecoxib twice daily and oral placebo twice daily Receives: Drug: Celecoxib; Drug: Placebo |
| Group 2 | Experimental | Patients receive oral celecoxib twice daily and oral ursodeoxycholic acid twice daily Receives: Drug: Celecoxib; Drug: Ursodeoxycholic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number and size of duodenal adenomas (assessed directly and by evaluation of video and photographic material from endoscopic procedures)
Measured: Baseline, 6 months
Secondary outcomes (2)
Cell proliferation, in normal mucosa and adenomas (if present)
Measured: Baseline, 6 months
Biliary acid profile (if present)
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2008 (estimated)
- Study startMay 2009
- Primary completionJul 2011
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Familial Adenomatous PolyposisStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Cancer Society
- Responsible party
- Sponsor
- Investigators
- Fokko M Nagengast, MD, Ph D, Principal investigator, University Medical Center St. Radboud Nijmegen, The NetherlandsBjorn WH van Heumen, MD, Principal investigator, University Medical Center St. Radboud Nijmegen, The NetherlandsWilbert HM Peters, Ph D, Principal investigator, University Medical Center St Radboud Nijmegen, The NetherlandsEllen Kampman, Ph D, Principal investigator, University Medical Center St Radboud Nijmegen, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00808743
- Sponsor's protocol ID
- RUN 2008-4198
- Other IDs
- ABR nr.: NL23569.091.08, CMO: 2008/148, EudraCT: 2008-003696-43
- Acronym
- PreDuoFAP
- Status last verified
- Aug 2010
- First submitted
- 15 Dec 2008
- Last updated
- 16 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
van Heumen BW, Roelofs HM, te Morsche RH, Nagengast FM, Peters WH. Duodenal mucosal risk markers in patients with familial adenomatous polyposis: effects of celecoxib/ursodeoxycholic acid co-treatment and comparison with patient controls. Orphanet J Rare Dis. 2013 Nov 19;8:181. doi: 10.1186/1750-1172-8-181.
PubMed 24245549van Heumen BW, Roelofs HM, Vink-Borger ME, Dekker E, Mathus-Vliegen EM, Dees J, Koornstra JJ, Langers AM, Nagtegaal ID, Kampman E, Peters WH, Nagengast FM. Ursodeoxycholic acid counteracts celecoxib in reduction of duodenal polyps in patients with familial adenomatous polyposis: a multicentre, randomized controlled trial. Orphanet J Rare Dis. 2013 Aug 6;8:118. doi: 10.1186/1750-1172-8-118.
PubMed 23919274
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Progression of Duodenal Adenomas to Cancer in Patients With Familial Adenomatous Polyposis (FAP)
- ClinicalTrials.gov ID
- NCT00808743
- Acronym / sponsor ID
- PreDuoFAP / RUN 2008-4198
- Keywords
- Familial adenomatous polyposis, Adenomatous Polyposis Coli, Digestive System Neoplasms, Gastrointestinal Disease, Intestinal disease, Intestinal neoplasms, Gastrointestinal neoplasms, Polyps
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Dutch Cancer Society
- Study start
- May 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 16 Dec 2008 (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.
Duodenal carcinomas are the leading cause of mortality in patients with Familial Adenomatous Polyposis (FAP) who underwent prophylactic colorectal surgery. The purpose of this study is to determine wether celecoxib combined with ursodeoxycholic acid is an effective chemoprevention strategy to influence the progression of duodenal adenomas to carcinomas in patients with FAP.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: Celecoxib, Drug: PlaceboPatients receive oral celecoxib twice daily and oral placebo twice daily |
| Group 2 | Experimental | Drug: Celecoxib, Drug: Ursodeoxycholic acidPatients receive oral celecoxib twice daily and oral ursodeoxycholic acid twice daily |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with Familial adenomatous Polyposis: APC-mutation identified or more than 100 colorectal polyps on diagnosis
- Spigelman score of duodenal adenoma equal to II or III
Key exclusion criteria (14 listed)
- Incapability of signing informed consent
- Active gastric or duodenal ulcer, gastrointestinal bleeding
- Cardiovascular disease or risk:
- Renal dysfunction: creatinine clearance below 50mL/min
- Liver dysfunction: albumin below 25 g/L or Child-Pugh-score equal to or below 10
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 |
|---|---|---|
| CelecoxibCelecoxib: 400mg twice daily, orally, 6 months | Drug | Group 1, Group 2 |
| Ursodeoxycholic acidUrsodeoxycholic acid: orally, 6 months, dosage based on body weight: below 50 kg: 1000mg, divided in two daily doses; 50-70 kg: 1500mg, divided in two daily doses; over 70 kg: 2000mg, divided in two daily doses | Drug | Group 2 |
| PlaceboPlacebo: orally, 6 months, dosage based on body weight: below 50 kg: 1000mg, divided in two daily doses; 50-70 kg: 1500mg, divided in two daily doses; over 70 kg: 2000mg, divided in two daily doses | Drug | Group 1 |
Primary outcome
Change in number and size of duodenal adenomas (assessed directly and by evaluation of video and photographic material from endoscopic procedures)
Time frame: Baseline, 6 months
2 secondary outcomes
Cell proliferation, in normal mucosa and adenomas (if present)
Time frame: Baseline, 6 months
Biliary acid profile (if present)
Time frame: Baseline, 6 months
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 16 May 2013.
- Derived from this study: PubMed 24245549van Heumen BW, Roelofs HM, te Morsche RH, Nagengast FM, Peters WH. Duodenal mucosal risk markers in patients with familial adenomatous polyposis: effects of celecoxib/ursodeoxycholic acid co-treatment and comparison with patient controls. Orphanet J Rare Dis. 2013 Nov 19;8:181. doi: 10.1186/1750-1172-8-181.
- Derived from this study: PubMed 23919274van Heumen BW, Roelofs HM, Vink-Borger ME, Dekker E, Mathus-Vliegen EM, Dees J, Koornstra JJ, Langers AM, Nagtegaal ID, Kampman E, Peters WH, Nagengast FM. Ursodeoxycholic acid counteracts celecoxib in reduction of duodenal polyps in patients with familial adenomatous polyposis: a multicentre, randomized controlled trial. Orphanet J Rare Dis. 2013 Aug 6;8:118. doi: 10.1186/1750-1172-8-118.
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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.
Fokko M Nagengast, MD, Ph D principal investigator
University Medical Center St. Radboud Nijmegen, The Netherlands
Bjorn WH van Heumen, MD principal investigator
University Medical Center St. Radboud Nijmegen, The Netherlands
Wilbert HM Peters, Ph D principal investigator
University Medical Center St Radboud Nijmegen, The Netherlands
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Celecoxib and Ursodeoxycholic acid in people with Familial Adenomatous Polyposis and Duodenal Neoplasms, run by Radboud University Medical Center at 5 sites in Netherlands.
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 14 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 16 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Netherlands. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change in number and size of duodenal adenomas (assessed directly and by evaluation of video and photographic material from endoscopic procedures) (time frame: Baseline, 6 months). 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 NCT00808743, which also lists 2 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 16 May 2013.