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Trial record 2 of 6 for:    mk0633

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00751413
Recruitment Status : Completed
First Posted : September 12, 2008
Last Update Posted : June 1, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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 or disease Intervention/treatment Phase
Asthma Drug: Comparator: MK0633 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
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
Study Start Date : August 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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 :
  1. 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. ]

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00751413

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

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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00751413     History of Changes
Other Study ID Numbers: 0633-023
First Posted: September 12, 2008    Key Record Dates
Last Update Posted: June 1, 2015
Last Verified: May 2015