FlushingPhase 2NCT00533676
Endpoint Validation Study (0524A-015)
A Phase 2 study testing MK0524A, /Duration of Treatment : 8 Weeks in people with Flushing, run by Merck Sharp & Dohme LLC.
Trial summary
To determine the most effective daily dose of MK0524A when compared with placebo after the 8-week treatment period for Niacin Induce Flushing (NIF). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Flushing
- What is being tested?
- MK0524A, /Duration of Treatment : 8 Weeks
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 165 participants
- Where
- No sites listed yet
- Study dates
- Aug 2004to Dec 2006
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be male or female between 18 to 70 years
- Qualified women must be sterile (through surgery) and/or post-menopausal, and/or agree to use birth control
Who cannot join
- You are a woman who is having hot flashes, receiving Hormone Replacement Therapy (HRT), and/or other therapies for hot flashes
- You are currently using Niacin/or Niacin containing products with a daily dose over 50 mg/day
- You are sensitive to niacin
- You have a history gout
- You drink more than 2 glasses of alcohol per day and you are not willing to stop
- You don't have access to a telephone
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Endpoint Selection and Questionnaire Validation Study to Assess the Niacin Induced Flushing Caused by NIASPAN (TM)
To determine the most effective daily dose of MK0524A when compared with placebo after the 8-week treatment period for Niacin Induce Flushing (NIF).
- Conditions
- Flushing
- Being tested
- MK0524A, /Duration of Treatment : 8 Weeks, Comparator : placebo (unspecified) /Duration of Treatment : 8 Weeks
- Medical subject headings
- Flushing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK0524A, /Duration of Treatment : 8 WeeksDrug
Comparator : placebo (unspecified) /Duration of Treatment : 8 WeeksDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the most effective daily dose and measurements to assess acute and chronic (long-lasting) Niacin Induce Flushing (NIF).
Measured: 8 weeks
Secondary outcomes (1)
To assess the the time points of Niacin Induce Flushing (NIF) across the 8-week treatment period.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2007 (estimated)
- Study startAug 2004
- Primary completionDec 2006
- Study completionDec 2006
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 FlushingStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 165 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
- NCT00533676
- Sponsor's protocol ID
- 0524A-015
- Other IDs
- MK0524A-015, 2007_612
- Status last verified
- Feb 2017
- First submitted
- 19 Sep 2007
- Last updated
- 17 Feb 2017
- Results posted
- No
Publications
Norquist JM, Watson DJ, Yu Q, Paolini JF, McQuarrie K, Santanello NC. Validation of a questionnaire to assess niacin-induced cutaneous flushing. Curr Med Res Opin. 2007 Jul;23(7):1549-60. doi: 10.1185/030079907x199637.
PubMed 17559750Paolini JF, Mitchel YB, Reyes R, Thompson-Bell S, Yu Q, Lai E, Watson DJ, Norquist JM, Sisk CM, Bays HE. Measuring flushing symptoms with extended-release niacin using the flushing symptom questionnaire: results from a randomised placebo-controlled clinical trial. Int J Clin Pract. 2008 Jun;62(6):896-904. doi: 10.1111/j.1742-1241.2008.01739.x. Epub 2008 Apr 10.
PubMed 18410350
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Endpoint Selection and Questionnaire Validation Study to Assess the Niacin Induced Flushing Caused by NIASPAN (TM)
- ClinicalTrials.gov ID
- NCT00533676
- Acronym / sponsor ID
- 0524A-015
- Conditions
- Flushing
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Aug 2004
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 21 Sep 2007 (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.
To determine the most effective daily dose of MK0524A when compared with placebo after the 8-week treatment period for Niacin Induce Flushing (NIF).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
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 must be male or female between 18 to 70 years
- Qualified women must be sterile (through surgery) and/or post-menopausal, and/or agree to use birth control
Key exclusion criteria (6 listed)
- You are a woman who is having hot flashes, receiving Hormone Replacement Therapy (HRT), and/or other therapies for hot flashes
- You are currently using Niacin/or Niacin containing products with a daily dose over 50 mg/day
- You are sensitive to niacin
- You have a history gout
- You drink more than 2 glasses of alcohol per day and you are not willing to stop
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 |
|---|---|---|
| MK0524A, /Duration of Treatment : 8 Weeks | Drug | – |
| Comparator : placebo (unspecified) /Duration of Treatment : 8 Weeks | Drug | – |
Primary outcome
To determine the most effective daily dose and measurements to assess acute and chronic (long-lasting) Niacin Induce Flushing (NIF).
Time frame: 8 weeks
1 secondary outcome
To assess the the time points of Niacin Induce Flushing (NIF) across the 8-week treatment period.
Time frame: 8 weeks
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 17 Feb 2017.
- Background: PubMed 17559750Norquist JM, Watson DJ, Yu Q, Paolini JF, McQuarrie K, Santanello NC. Validation of a questionnaire to assess niacin-induced cutaneous flushing. Curr Med Res Opin. 2007 Jul;23(7):1549-60. doi: 10.1185/030079907x199637.
- Background: PubMed 18410350Paolini JF, Mitchel YB, Reyes R, Thompson-Bell S, Yu Q, Lai E, Watson DJ, Norquist JM, Sisk CM, Bays HE. Measuring flushing symptoms with extended-release niacin using the flushing symptom questionnaire: results from a randomised placebo-controlled clinical trial. Int J Clin Pract. 2008 Jun;62(6):896-904. doi: 10.1111/j.1742-1241.2008.01739.x. Epub 2008 Apr 10.
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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 MK0524A, /Duration of Treatment : 8 Weeks in people with Flushing, 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 2 inclusion and 6 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 17 Feb 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 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 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?
To determine the most effective daily dose and measurements to assess acute and chronic (long-lasting) Niacin Induce Flushing (NIF). (time frame: 8 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 NCT00533676, 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 17 Feb 2017.