Plasma Levels of MK0633 in Children Ages 6-12

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00751413
First received: September 11, 2008
Last updated: May 6, 2009
Last verified: May 2009

September 11, 2008
May 6, 2009
August 2008
January 2009   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00751413 on ClinicalTrials.gov Archive Site
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. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Plasma Levels of MK0633 in Children Ages 6-12
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Asthma
Drug: Comparator: MK0633
A single dose of MK0633 10 mg or 25 mg film coated tablet. Dose will be based on patient weight.
Experimental: 1
MK0633
Intervention: Drug: Comparator: MK0633
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
July 2009
January 2009   (final data collection date for primary outcome measure)

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
Both
6 Years to 11 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00751413
2008_529, MK0633-023
Not Provided
Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP