Bone NeoplasmsPhase 2NCT00095017
Safety and Efficacy of an Investigational Drug Versus Placebo in the Treatment of Cancer Pain (0663-083)
A Phase 2 study testing MK0663, etoricoxib / Duration of Treatment: 4 weeks in people with Bone Neoplasms, run by Organon and Co.
Trial summary
The purpose of this study is to compare the effectiveness of an investigational drug versus placebo in the treatment of metastatic bone cancer pain in patients diagnosed with breast or prostate cancer and a bone neoplasm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Neoplasms
- What is being tested?
- MK0663, etoricoxib / Duration of Treatment: 4 weeks
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2004to not given
- Phase
- Phase 2
- 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
- Patients are required to have a diagnosis of breast or prostate cancer with bone involvement and moderate to severe pain that requires opioid treatment.
Who cannot join
None listed.
About this study
Official title: A 4 Week Randomized, Placebo-Controlled, Parallel Group, Double-Blind Pilot Study to Assess the Safety and Efficacy of Etoricoxib 90 mg Versus Placebo in the Treatment of Cancer Pain
The purpose of this study is to compare the effectiveness of an investigational drug versus placebo in the treatment of metastatic bone cancer pain in patients diagnosed with breast or prostate cancer and a bone neoplasm. Patients in the study will be taking opioids to treat moderate to severe pain for their bone metastases and will remain on their opioids during the entire course of the study.
- Conditions
- Bone Neoplasms
- Being tested
- MK0663, etoricoxib / Duration of Treatment: 4 weeks
- Keywords
- Arcoxia
- Medical subject headings
- Bone Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK0663, etoricoxib / Duration of Treatment: 4 weeksDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesic efficacy over a 4 week treatment period; Safety and tolerability.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2004 (estimated)
- Study startNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone NeoplasmsStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- 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
- NCT00095017
- Sponsor's protocol ID
- 0663-083
- Other IDs
- 2004_090
- Status last verified
- Feb 2022
- First submitted
- 29 Oct 2004
- Last updated
- 16 Feb 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 4 Week Randomized, Placebo-Controlled, Parallel Group, Double-Blind Pilot Study to Assess the Safety and Efficacy of Etoricoxib 90 mg Versus Placebo in the Treatment of Cancer Pain
- ClinicalTrials.gov ID
- NCT00095017
- Acronym / sponsor ID
- 0663-083
- Conditions
- Bone Neoplasms
- Keywords
- Arcoxia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- First posted
- 1 Nov 2004 (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.
The purpose of this study is to compare the effectiveness of an investigational drug versus placebo in the treatment of metastatic bone cancer pain in patients diagnosed with breast or prostate cancer and a bone neoplasm. Patients in the study will be taking opioids to treat moderate to severe pain for their bone metastases and will remain on their opioids during the entire course of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients are required to have a diagnosis of breast or prostate cancer with bone involvement and moderate to severe pain that requires opioid treatment.
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 |
|---|---|---|
| MK0663, etoricoxib / Duration of Treatment: 4 weeks | Drug | – |
Primary outcome
Analgesic efficacy over a 4 week treatment period; Safety and tolerability.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
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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 2 study testing MK0663, etoricoxib / Duration of Treatment: 4 weeks in people with Bone Neoplasms, run by Organon and Co.
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: withdrawn, as of the sponsor's last update on 16 Feb 2022. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 withdrawn before enrolling participants, so there are no results.
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?
Analgesic efficacy over a 4 week treatment period; Safety and tolerability.. 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 16 Feb 2022.