Study Evaluating Brompheniramine Maleate Liquid in Children and Adolescents
NCT00894634
ABOUT THIS STUDY
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1. Males or females between 2 to less than 18 yrs of age with a minimum weight of 24 pounds and within the 5th and 95th percentiles in height and weight, and BMI based on age and gender
2. Symptomatic or asymptomatic children/adolescents as follows:
- A prior diagnosis of allergic rhinitis and either symptomatic or asymptomatic at the time of entry in the study; or * Symptoms of an acute URI; or
- No symptoms of an acute URI, but at risk for developing an acute URI as evidenced by the following frequency, crowding, and exposure criteria:
- Frequency: a history of frequent URIs defined as greater than 6 infections/yr for children aged 2 to less than 6 yrs and as greater than 4 infections per year for adolescents aged 6 to less than 18 yrs;
- Crowding: living in a home with greater than 4 persons, or sleeping in the same bedroom with greater than 3 persons;
- Exposure: the presence of another family member in the household who is ill with a URI, or a child in the family that is attending preschool, or attending school with greater than 6 children in the class;
3. Except for allergic rhinitis or a URI, children/adolescents are in normal physical health (i.e., no clinically significant systemic disease) as judged by the Investigator upon physical examination of the subject;
4. Subjects do not require concomitant medication except for low-dose inhaled glucocorticoids for allergic rhinitis or mild concomitant asthma, if dose is stabilized before entry in the study (i.e., dose is not changed for one month prior to or during the study), and inhaled short-acting beta-2 adrenergic agonists for concomitant asthma, as needed;
5. Post menarchal females must be using a reliable method of contraception (i.e., oral, transdermal, injectable or implanted contraceptives, IUD, cervical cap, diaphragm, condom, abstinence, or surgical sterility).
1. The child/adolescent weighs less than 24 pounds or is below the 5th or above the 95th
percentiles in physical growth characteristics (i.e., height and weight), and BMI
based on age and gender;
2. Inability to swallow the medication;
3. Eaten within 2 hours prior to dosing;
4. A known hypersensitivity to BROM, any other antihistamine, or EMLA cream;
5. Systolic and/or diastolic blood pressure at or above the 95th percentile based on
gender, and age and height percentiles. (Note: If a subject with no history of
hypertension has a blood pressure reading at or above the 95th percentile, the subject
will be allowed to rest for 15 minutes and the blood pressure measurement repeated. Up
to 3 consecutive measurements at approximately 5 min intervals will be allowed.
Subjects who continue to have systolic and/or diastolic blood pressure readings at or
above the 95th percentile will be excluded from the study);
6. History of melena or any hepatic, renal, endocrine (e.g., diabetes, thyroid disorder),
cardiac, neurological, psychiatric, gastrointestinal, hematological or metabolic
disorder deemed to be clinically significant by the Investigator;
7. Any serious medical condition or medical history felt by the Investigator to place
them at increased risk;
8. The child is diagnosed with anemia or has a red blood cell count or hemoglobin level
outside of normal range as evidenced by baseline hematology assessment;
9. Asthma symptoms at the time of entry in the study or requires medication other than
allowed under Inclusion Criterion d;
10. Failure to comply with appropriate washout periods for any H-1 receptor antagonist
treatment before and during the study, i.e., no use within 7 days of entering the
study or at any time during the study, and no use of astemizole within the preceding 3
calendar months;
11. Other than described in Exclusion Criterion i, use of any medication 72 hours prior to
dosing;
12. A history of drug, alcohol, or tobacco abuse (older children and adolescents), a
history of Hepatitis B, a previous positive test for Hepatitis B surface antigen, or a
previous positive Hepatitis C antibody;
13. A history of HIV infection or previous demonstration of HIV antibodies;
14. Female subjects who have experienced menarche and have a positive urine pregnancy
test;
15. Parent/guardian/subject judged by the Investigator to be unable or unwilling to comply
with the requirements of the protocol;
16. Have taken an investigational drug within 30 days prior to entering the study or have
already participated in the trial;
17. Relative of the Sponsor, Investigator, or any personnel of the study site who are
directly involved with the study.
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Descriptive Information | ||||
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Brief Title ICMJE | Study Evaluating Brompheniramine Maleate Liquid in Children and Adolescents | |||
Official Title ICMJE | A Single-Dose, Open-Label, Pharmacokinetic Study of Brompheniramine Maleate Liquid in Children and Adolescents | |||
Brief Summary | The objective of this study is to characterize the pharmacokinetic (PK) profile of brompheniramine maleate (BROM) in children and adolescents, ages 2 to less than 18 years following dosing in accordance with current weight-age dosing guidelines. Once characterized, the PK data will be pooled with adult PK data from other studies and analyzed under a separate analysis plan to confirm or refine the existing OTC doses in children aged 2 to <12 yrs and adolescents aged 12 to <18 yrs. | |||
Detailed Description | Not Provided | |||
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: Brompheniramine maleate | |||
Study Arms ICMJE | Experimental: Brompheniramine maleate
Brompheniramine maleate oral solution 1 mg/5 mL, single dose Intervention: Drug: Brompheniramine maleate | |||
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 | 37 | |||
Original Estimated Enrollment ICMJE | 30 | |||
Actual Study Completion Date ICMJE | April 26, 2009 | |||
Actual Primary Completion Date | April 26, 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 2 Years to 17 Years (Child) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00894634 | |||
Other Study ID Numbers ICMJE | BF-08-06 | |||
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 |