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 levles 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 ]

Estimated Enrollment:	22
Study Start Date:	August 2008
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	November 2008 (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

Contacts

Contact: Toll Free Number

1-888-577-8839

Locations

United States, California
Call for Information	Recruiting
San Diego, California, United States, 92123
United States, Colorado
Call for Information	Recruiting
Denver, Colorado, United States, 80206-2762
United States, Michigan
Call for Information	Recruiting
Kalamazoo, Michigan, United States, 49007
United States, Ohio
Call for Information	Recruiting
Cleveland, Ohio, United States, 44106
Call for Information	Recruiting
Cincinnati, Ohio, United States, 45229
United States, Pennsylvania
Call for Information	Recruiting
Philadelphia, Pennsylvania, United States, 19107-5244

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

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:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00751413
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Asthma

ClinicalTrials.gov processed this record on January 16, 2009