Duodenal PolyposisPhase 2/3NCT00844727
Coxib-inhibition of Duodenal Polyp Growth in FAP
A Phase 2/3 study testing Rofecoxib in people with Duodenal Polyposis, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Preliminary data indicate a protective effect on the development of duodenal polyps by coxib treatment. The hypothesis of the present study is that normal therapy doses of rofecoxib for 1 year would stop or reverse the development of premalignant adenomatous lesions in the duodenal mucosa of FAP patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Duodenal Polyposis
- What is being tested?
- Rofecoxib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2003to Apr 2004
- 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
- FAP patient with previous colectomy and confirmed polyposis
Who cannot join
- Pregnancy
- Malignancy
- NSAID hypersensitivity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Coxib-inhibition of Duodenal Polyp Growth in Familial Adenomatous Polyposis
Preliminary data indicate a protective effect on the development of duodenal polyps by coxib treatment. The hypothesis of the present study is that normal therapy doses of rofecoxib for 1 year would stop or reverse the development of premalignant adenomatous lesions in the duodenal mucosa of FAP patients.
- Conditions
- Duodenal Polyposis
- Being tested
- Rofecoxib, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RofecoxibDrug
placeboDrug
placebo pills
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Rofexocib 25 mg OD, 1 year treatment Receives: Drug: Rofecoxib |
| 2 | Placebo comparator | Placebo Receives: Drug: placebo |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2009 (estimated)
- Study startSep 2003
- Primary completionApr 2004
- Study completionApr 2004
Why it stopped: Drug withdrawal
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Duodenal PolyposisStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00844727
- Sponsor's protocol ID
- RH01/01
- Status last verified
- Feb 2009
- First submitted
- 13 Feb 2009
- Last updated
- 6 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coxib-inhibition of Duodenal Polyp Growth in Familial Adenomatous Polyposis
- ClinicalTrials.gov ID
- NCT00844727
- Acronym / sponsor ID
- RH01/01
- Conditions
- Duodenal Polyposis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Drug withdrawal
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Sep 2003
- Primary completion
- Apr 2004 (actual)
- Study completion
- Apr 2004 (actual)
- First posted
- 16 Feb 2009 (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.
Preliminary data indicate a protective effect on the development of duodenal polyps by coxib treatment. The hypothesis of the present study is that normal therapy doses of rofecoxib for 1 year would stop or reverse the development of premalignant adenomatous lesions in the duodenal mucosa of FAP patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: RofecoxibRofexocib 25 mg OD, 1 year treatment |
| 2 | Placebo comparator | Drug: placeboPlacebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- FAP patient with previous colectomy and confirmed polyposis
Key exclusion criteria (3 listed)
- Pregnancy
- Malignancy
- NSAID hypersensitivity
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 |
|---|---|---|
| Rofecoxib | Drug | 1 |
| placeboplacebo pills | Drug | 2 |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Drug withdrawal). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 Rofecoxib in people with Duodenal Polyposis, run by Oslo University Hospital at 1 site in Norway.
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 1 inclusion and 3 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: stopped early, as of the sponsor's last update on 6 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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 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 was stopped early (reason given: Drug withdrawal). Results are not available in the source record.
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.
Where can I read the original study information?
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 Jul 2011.