Study Evaluating Chlorpheniramine Maleate Liquid in Children and Adolescents
NCT00837837
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Study Evaluating Chlorpheniramine Maleate Liquid in Children and Adolescents | |||
Official Title ICMJE | A Single-Dose, Open-Label, Pharmacokinetic Study of Chlorpheniramine Maleate Liquid in Children and Adolescents | |||
Brief Summary | The purpose of this study is to examine the pharmacokinetic parameters of chlorpheniramine in children and adolescents. | |||
Detailed Description | This is a single-group, single-center, open-label, one period, bioavailability study. This study will evaluate the pharmacokinetic (PK) profile of chlorpheniramine in a population of children aged 2 to <12 yrs and adolescents aged 12 to <18 yrs. Twelve blood samples (3.0 mL) for chlorpheniramine analysis will be drawn at time 0 (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours after dosing. Plasma levels of chlorpheniramine will be determined. The following primary, single-dose PK parameters for chlorpheniramine will be determined using noncompartmental methods: AUCL, AUCI, and Cmax. The following PK parameters will also be determined to provide a complete profile of the drug, as appropriate: oral clearance (CL) and volume of distribution (Vd) and adjusted for body weight (per kg); time to reach Cmax (tmax), and apparent elimination constant (Kel) and half-life (t1/2). The PK parameters will be summarized using descriptive statistics. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Allergic Reactions | |||
Intervention ICMJE | Drug: Chlorpheniramine | |||
Study Arms ICMJE | Experimental: Chlorpheniramine
Chlorpheniramine dose by body weight. Intervention: Drug: Chlorpheniramine | |||
Publications * | Pathirana S, Jayawardena S, Meeves S, Thompson GA. Brompheniramine and Chlorpheniramine Pharmacokinetics Following Single-Dose Oral Administration in Children Aged 2 to 17 Years. J Clin Pharmacol. 2018 Apr;58(4):494-503. doi: 10.1002/jcph.1037. Epub 2017 Nov 14. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 36 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | February 2, 2009 | |||
Actual Primary Completion Date | February 2, 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | INCLUSION CRITERIA: Individuals may be enrolled in the study if they meet all of the following criteria:
i.A prior diagnosis of allergic rhinitis and either symptomatic or asymptomatic at the time of entry in the study; or ii.Symptoms of an acute Upper Respiratory Infection (URI); or iii.No symptoms of an acute URI, but at risk for developing an acute URI as evidenced by the following frequency, crowding, and exposure criteria:
EXCLUSION CRITERIA: Individuals are not eligible for entry in the study if any of the following are noted:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 2 Years to 17 Years (Child) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | United States | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00837837 | |||
Other Study ID Numbers ICMJE | CF-08-01 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Verification Date | October 2020 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |