Plasma Levels of MK0633 in Children Ages 6-12 - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00751413

Purpose

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 I

MedlinePlus related topics: Asthma

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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:

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. ] [ Designated as safety issue: Yes ]

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. ] [ Designated as safety issue: No ]

Enrollment:	22
Study Start Date:	August 2008
Estimated Study Completion Date:	July 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental MK0633	Drug: Comparator: MK0633 A single dose of MK0633 10 mg or 25 mg film coated tablet. Dose will be based on patient weight.

Eligibility

Criteria

Inclusion Criteria:

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00751413

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2008_529, MK0633-023
Study First Received:	September 11, 2008
Last Updated:	May 6, 2009
ClinicalTrials.gov Identifier:	NCT00751413 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Asthma

ClinicalTrials.gov processed this record on May 07, 2009