This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Plasma Levels of MK0633 in Children Ages 6-12 (0633-023)

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: September 11, 2008
Last updated: May 29, 2015
Last verified: May 2015
To evaluate the safety, tolerability and plasma levels of single oral doses of MK0633 in pediatric asthma patients ages 6 to less than 12 years.

Condition Intervention Phase
Asthma Drug: Comparator: MK0633 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label, Single Dose Study to Evaluate the Safety, Tolerability and Plasma Concentration Profiles of MK0633 in Asthmatic Children Aged 6 to Less Than 12 Years

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • To evaluate the safety and tolerability of single oral doses of MK0633 in pediatric asthma patients. [ Time Frame: Physical examinations, vital sign measurements, laboratory safety tests (blood chemistry, hematology and urinalysis), urine ß-hCG test, and 12-lead ECGs will be performed at various scheduled time points throughout the study. ]

Secondary Outcome Measures:
  • To obtain information on plasma pharmacokinetics (e.g., AUC0-inf, Cmax, Tmax, apparent t½,) of MK0633 after a single oral dose administration in pediatric asthma patients [ Time Frame: Plasma will be analyzed at specific time-points for MK0633 concentrations. Urine will be collected for the measurement of LTE4 concentration. ]

Enrollment: 22
Study Start Date: August 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug: Comparator: MK0633
A single dose of MK0633 10 mg or 25 mg film coated tablet. Dose will be based on patient weight.


Ages Eligible for Study:   6 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient has mild to moderate asthma
  • Patient is able to swallow pills
  • Patient is able to have have blood draws

Exclusion Criteria:

  • Patient has required a visit to the hospital or emergency room due to an asthmatic event in the last 3 months
  • Patient has an upper respiratory tract infection (URI)
  • Patient has a history of stroke
  • Patient consumes more than 4 caffeinated beverages per day
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00751413

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00751413     History of Changes
Other Study ID Numbers: 0633-023
Study First Received: September 11, 2008
Last Updated: May 29, 2015 processed this record on August 18, 2017