Endpoint Validation Study (0524A-015)
Primary Purpose
Flushing
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
MK0524A, /Duration of Treatment : 8 Weeks
Comparator : placebo (unspecified) /Duration of Treatment : 8 Weeks
Sponsored by
About this trial
This is an interventional treatment trial for Flushing
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
Outcomes
Primary Outcome Measures
To determine the most effective daily dose and measurements to assess acute and chronic (long-lasting) Niacin Induce Flushing (NIF).
Secondary Outcome Measures
To assess the the time points of Niacin Induce Flushing (NIF) across the 8-week treatment period.
Full Information
NCT ID
NCT00533676
First Posted
September 19, 2007
Last Updated
February 16, 2017
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00533676
Brief Title
Endpoint Validation Study (0524A-015)
Official Title
A Randomized, Double-Blind, Placebo-Controlled Endpoint Selection and Questionnaire Validation Study to Assess the Niacin Induced Flushing Caused by NIASPAN (TM)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Flushing
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
165 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0524A, /Duration of Treatment : 8 Weeks
Intervention Type
Drug
Intervention Name(s)
Comparator : placebo (unspecified) /Duration of Treatment : 8 Weeks
Primary Outcome Measure Information:
Title
To determine the most effective daily dose and measurements to assess acute and chronic (long-lasting) Niacin Induce Flushing (NIF).
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
To assess the the time points of Niacin Induce Flushing (NIF) across the 8-week treatment period.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
17559750
Citation
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.
Results Reference
background
PubMed Identifier
18410350
Citation
Paolini 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.
Results Reference
background
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Snyopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Learn more about this trial
Endpoint Validation Study (0524A-015)
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