Adenomatous Polyposis ColiPhase 4NCT00140894
A Study of Rofecoxib in Familial Adenomatous Polyposis (FAP) (0966-205)(TERMINATED)
A Phase 4 study testing MK0966; rofecoxib / Duration of Treatment: 24 weeks in people with Adenomatous Polyposis Coli, run by Merck Sharp & Dohme LLC.
Trial summary
A study to evaluate rofecoxib in the treatment of rectal, colon, or duodenal adenomas in patients with Familial Adenomatous Polyposis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenomatous Polyposis Coli
- What is being tested?
- MK0966; rofecoxib / Duration of Treatment: 24 weeks
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- 6 Aug 2002to 11 Oct 2004
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females at least 18 years of age with familial adenomatous polyposis.
Who cannot join
None listed.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Rofecoxib in Familial Adenomatous Polyposis (FAP)
A study to evaluate rofecoxib in the treatment of rectal, colon, or duodenal adenomas in patients with Familial Adenomatous Polyposis.
- Conditions
- Adenomatous Polyposis Coli
- Being tested
- MK0966; rofecoxib / Duration of Treatment: 24 weeks, Comparator: placebo / Duration of Treatment: 24 weeks
- Keywords
- Osteoarthritis, Cancer Pain
- Medical subject headings
- Adenomatous Polyposis Coli, Osteoarthritis, Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK0966; rofecoxib / Duration of Treatment: 24 weeksDrug
Comparator: placebo / Duration of Treatment: 24 weeksDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and average size of rectal polyps
Safety and tolerability
Secondary outcomes (2)
Number and average size of duodenal polyps
Proportions of patients with improved overall colon rating
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 start6 Aug 2002
- Study completion11 Oct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenomatous Polyposis ColiStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 62 participants
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00140894
- Sponsor's protocol ID
- 0966-205
- Other IDs
- 2005_052
- Status last verified
- Sep 2019
- First submitted
- 30 Aug 2005
- Last updated
- 20 Sep 2019
- Results posted
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Rofecoxib in Familial Adenomatous Polyposis (FAP)
- ClinicalTrials.gov ID
- NCT00140894
- Acronym / sponsor ID
- 0966-205
- Conditions
- Adenomatous Polyposis Coli
- Keywords
- Osteoarthritis, Cancer Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 62 participants
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 6 Aug 2002 (actual)
- Study completion
- 11 Oct 2004 (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.
A study to evaluate rofecoxib in the treatment of rectal, colon, or duodenal adenomas in patients with Familial Adenomatous Polyposis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Males or females at least 18 years of age with familial adenomatous polyposis.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| MK0966; rofecoxib / Duration of Treatment: 24 weeks | Drug | – |
| Comparator: placebo / Duration of Treatment: 24 weeks | Drug | – |
Primary outcome
Number and average size of rectal polyps
Safety and tolerability
2 secondary outcomes
Number and average size of duodenal polyps
Proportions of patients with improved overall colon rating
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2019.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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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.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MK0966; rofecoxib / Duration of Treatment: 24 weeks in people with Adenomatous Polyposis Coli, run by Merck Sharp & Dohme LLC.
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 0 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 20 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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. 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.
What does the primary outcome measure?
Number and average size of rectal polyps. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 20 Sep 2019.