Colorectal AdenomaPhase 3NCT00282386
A Study to Evaluate the Effect of MK0966 (Rofecoxib) on the Recurrence of Colorectal Adenomas (0966-122)
A Phase 3 study testing MK0966; Rofecoxib / Duration of Treatment: 156 weeks in people with Colorectal Adenoma, run by Merck Sharp & Dohme LLC.
Trial summary
This study was to compare the effect of 156 weeks of treatment with MK-0966 (Rofecoxib) versus placebo on the recurrence of colorectal adenomas (growths that occur on the inside (the lining) of the large intestine, also known as the colon) in patients with a history of colorectal adenomas. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Colorectal Adenoma
- What is being tested?
- MK0966; Rofecoxib / Duration of Treatment: 156 weeks
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,586 participants
- Where
- No sites listed yet
- Study dates
- 23 Dec 1999to 1 Sep 2004
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible patients must have undergone a complete colonoscopy within 12 weeks of study entry with removal of all polyps; at least one polyp must have been confirmed a large bowel pre-cancerous polyp (adenoma) by the study pathologist.
Who cannot join
- History with a specific hereditary large bowel polyp syndrome
- History of a large bowel adenoma before age 35
- Small or large bowel resection or history of inflammatory bowel disease
- History of cancer within the five years before enrollment
- Expected need for chronic NSAID therapy
- Positive test result for stool occult blood
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- Uncontrolled hypertension, stroke or temporary mini stroke (TIA) within the past 2 years, angina or congestive heart failure with symptoms that occur at rest or with minimal activity
- History of myocardial infarction (heart attack), coronary angioplasty, or coronary artery bypass grafting within the past 1 year
- Pregnancy
About this study
Official title: A Multicenter, Randomized, Parallel-Group, Placebo-Controlled, Double-Blind Study With In-House Blinding to Determine the Effect of 156 Weeks of Treatment With MK0966 on the Recurrence of Neoplastic Polyps of the Large Bowel in Patients With a History of Colorectal Adenomas
This study was to compare the effect of 156 weeks of treatment with MK-0966 (Rofecoxib) versus placebo on the recurrence of colorectal adenomas (growths that occur on the inside (the lining) of the large intestine, also known as the colon) in patients with a history of colorectal adenomas.
- Conditions
- Colorectal Adenoma
- Being tested
- MK0966; Rofecoxib / Duration of Treatment: 156 weeks, Placebo/ Duration of Treatment: 156 weeks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK0966; Rofecoxib / Duration of Treatment: 156 weeksDrug
Placebo/ Duration of Treatment: 156 weeksDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative colorectal adenoma recurrence during treatment in patients with an increased risk to develop colorectal cancer.
Measured: 156 Weeks
Secondary outcomes (3)
Cumulative colorectal adenoma recurrence during treatment in patients with a history of colorectal adenoma
Measured: 156 Weeks
Cumulative colorectal adenoma recurrence during treatment in all patients
Measured: 52 Weeks
To evaluate safety & tolerability of rofecoxib
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2006 (estimated)
- Study start23 Dec 1999
- Primary completion1 Sep 2004
- Study completion1 Sep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2,586 participants (actual)
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
- NCT00282386
- Sponsor's protocol ID
- 0966-122
- Other IDs
- 2006_005
- Status last verified
- May 2017
- First submitted
- 24 Jan 2006
- Last updated
- 9 May 2017
- Results posted
- No
Publications
Bresalier RS, Sandler RS, Quan H, Bolognese JA, Oxenius B, Horgan K, Lines C, Riddell R, Morton D, Lanas A, Konstam MA, Baron JA; Adenomatous Polyp Prevention on Vioxx (APPROVe) Trial Investigators. Cardiovascular events associated with rofecoxib in a colorectal adenoma chemoprevention trial. N Engl J Med. 2005 Mar 17;352(11):1092-102. doi: 10.1056/NEJMoa050493. Epub 2005 Feb 15.
PubMed 15713943Baron JA, Sandler RS, Bresalier RS, Quan H, Riddell R, Lanas A, Bolognese JA, Oxenius B, Horgan K, Loftus S, Morton DG; APPROVe Trial Investigators. A randomized trial of rofecoxib for the chemoprevention of colorectal adenomas. Gastroenterology. 2006 Dec;131(6):1674-82. doi: 10.1053/j.gastro.2006.08.079. Epub 2006 Sep 1.
PubMed 17087947Lanas A, Baron JA, Sandler RS, Horgan K, Bolognese J, Oxenius B, Quan H, Watson D, Cook TJ, Schoen R, Burke C, Loftus S, Niv Y, Ridell R, Morton D, Bresalier R. Peptic ulcer and bleeding events associated with rofecoxib in a 3-year colorectal adenoma chemoprevention trial. Gastroenterology. 2007 Feb;132(2):490-7. doi: 10.1053/j.gastro.2006.11.012. Epub 2006 Nov 10.
PubMed 17258718Baron JA, Sandler RS, Bresalier RS, Lanas A, Morton DG, Riddell R, Iverson ER, Demets DL. Cardiovascular events associated with rofecoxib: final analysis of the APPROVe trial. Lancet. 2008 Nov 15;372(9651):1756-64. doi: 10.1016/S0140-6736(08)61490-7. Epub 2008 Oct 14.
PubMed 18922570
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Parallel-Group, Placebo-Controlled, Double-Blind Study With In-House Blinding to Determine the Effect of 156 Weeks of Treatment With MK0966 on the Recurrence of Neoplastic Polyps of the Large Bowel in Patients With a History of Colorectal Adenomas
- ClinicalTrials.gov ID
- NCT00282386
- Acronym / sponsor ID
- 0966-122
- Conditions
- Colorectal Adenoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,586 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 23 Dec 1999 (actual)
- Primary completion
- 1 Sep 2004 (actual)
- Study completion
- 1 Sep 2004 (actual)
- First posted
- 26 Jan 2006 (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 was to compare the effect of 156 weeks of treatment with MK-0966 (Rofecoxib) versus placebo on the recurrence of colorectal adenomas (growths that occur on the inside (the lining) of the large intestine, also known as the colon) in patients with a history of colorectal adenomas.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible patients must have undergone a complete colonoscopy within 12 weeks of study entry with removal of all polyps; at least one polyp must have been confirmed a large bowel pre-cancerous polyp (adenoma) by the study pathologist.
Key exclusion criteria (9 listed)
- History with a specific hereditary large bowel polyp syndrome
- History of a large bowel adenoma before age 35
- Small or large bowel resection or history of inflammatory bowel disease
- History of cancer within the five years before enrollment
- Expected need for chronic NSAID therapy
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: 156 weeks | Drug | – |
| Placebo/ Duration of Treatment: 156 weeks | Drug | – |
Primary outcome
Cumulative colorectal adenoma recurrence during treatment in patients with an increased risk to develop colorectal cancer.
Time frame: 156 Weeks
3 secondary outcomes
Cumulative colorectal adenoma recurrence during treatment in patients with a history of colorectal adenoma
Time frame: 156 Weeks
Cumulative colorectal adenoma recurrence during treatment in all patients
Time frame: 52 Weeks
To evaluate safety & tolerability of rofecoxib
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 9 May 2017.
- Background: PubMed 15713943Bresalier RS, Sandler RS, Quan H, Bolognese JA, Oxenius B, Horgan K, Lines C, Riddell R, Morton D, Lanas A, Konstam MA, Baron JA; Adenomatous Polyp Prevention on Vioxx (APPROVe) Trial Investigators. Cardiovascular events associated with rofecoxib in a colorectal adenoma chemoprevention trial. N Engl J Med. 2005 Mar 17;352(11):1092-102. doi: 10.1056/NEJMoa050493. Epub 2005 Feb 15.
- Background: PubMed 17087947Baron JA, Sandler RS, Bresalier RS, Quan H, Riddell R, Lanas A, Bolognese JA, Oxenius B, Horgan K, Loftus S, Morton DG; APPROVe Trial Investigators. A randomized trial of rofecoxib for the chemoprevention of colorectal adenomas. Gastroenterology. 2006 Dec;131(6):1674-82. doi: 10.1053/j.gastro.2006.08.079. Epub 2006 Sep 1.
- Background: PubMed 17258718Lanas A, Baron JA, Sandler RS, Horgan K, Bolognese J, Oxenius B, Quan H, Watson D, Cook TJ, Schoen R, Burke C, Loftus S, Niv Y, Ridell R, Morton D, Bresalier R. Peptic ulcer and bleeding events associated with rofecoxib in a 3-year colorectal adenoma chemoprevention trial. Gastroenterology. 2007 Feb;132(2):490-7. doi: 10.1053/j.gastro.2006.11.012. Epub 2006 Nov 10.
- Derived from this study: PubMed 18922570Baron JA, Sandler RS, Bresalier RS, Lanas A, Morton DG, Riddell R, Iverson ER, Demets DL. Cardiovascular events associated with rofecoxib: final analysis of the APPROVe trial. Lancet. 2008 Nov 15;372(9651):1756-64. doi: 10.1016/S0140-6736(08)61490-7. Epub 2008 Oct 14.
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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 3 study testing MK0966; Rofecoxib / Duration of Treatment: 156 weeks in people with Colorectal Adenoma, 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 9 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 9 May 2017. 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 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?
Cumulative colorectal adenoma recurrence during treatment in patients with an increased risk to develop colorectal cancer. (time frame: 156 Weeks). 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 NCT00282386, which also lists 4 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 9 May 2017.