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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00751413
First received: September 11, 2008
Last updated: June 26, 2014
Last verified: June 2014
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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. ] [ 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
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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

Ages Eligible for Study:   6 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00751413

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

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00751413     History of Changes
Other Study ID Numbers: 0633-023, MK0633-023, 2008_529
Study First Received: September 11, 2008
Last Updated: June 26, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 16, 2014