Endpoint Validation Study (0524A-015)

Flushing Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled Endpoint Selection and Questionnaire Validation Study to Assess the Niacin Induced Flushing Caused by NIASPAN (TM)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00533676
• Other study ID #: 0524A-015
• Secondary ID: MK0524A-0152007_
• Status: Completed
• Phase: Phase 2
• First received: September 19, 2007
• Last updated: February 16, 2017
• Start date: August 2004
• Est. completion date: December 2006

Study information

• Verified date: February 2017
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Flushing

Intervention

Drug:
• MK0524A, /Duration of Treatment : 8 Weeks

• Comparator : placebo (unspecified) /Duration of Treatment : 8 Weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the most effective daily dose and measurements to assess acute and chronic (long-lasting) Niacin Induce Flushing (NIF).		8 weeks
Secondary	To assess the the time points of Niacin Induce Flushing (NIF) across the 8-week treatment period.		8 weeks