A Multicenter Study of Pseudoephedrine for the Temporary Relief of Nasal Congestion in Children With the Common Cold

Conditions:Infectious Disease, Pulmonary
Therapuetic Areas:Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases
Age Range:6 - 11
Start Date:November 2012
End Date:May 2016

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A Multicenter, Randomized, Placebo-Controlled Study of Pseudoephedrine for the Temporary Relief of Nasal Congestion in Children With the Common Cold

This study is designed to confirm the effectiveness of single-ingredient pseudoephedrine in
children for the temporary relief of nasal congestion due to the common cold, an indication
described under 21 CFR 341.80(b)(1).

Inclusion Criteria:

1. Male or female subjects, ages 6 through 11 years, are experiencing the common cold,
but are otherwise healthy.

2. Subjects have an onset of cold symptoms within the past 2.5 days before screening and
are experiencing self-reported nasal congestion of at least stuffy severity (score =
3 or 4).

3. Subjects have at least two of the following additional symptoms due to common cold:
runny nose, sneezing, sore throat, headache, body achiness, and cough, as deemed by
the parent.

4. Subjects can swallow oral tablets without chewing them (based on a pretest of
successfully swallowing a placebo tablet at screening)

5. Findings from the medical history review and vital signs are within the range of
clinical acceptability, as determined by the investigator.

6. Subject and legally authorized representative are likely to be compliant and complete
the study.

7. Subject's legally authorized representative has signed and dated the informed consent
form. Subject has given verbal assent, and has signed and dated the informed assent

8. Female subjects who have reached menarche must have a negative urine pregnancy test
at screening. These subjects must have practiced abstinence for at least three months
prior to study entry and for the duration of the study. A second pregnancy test will
be given when the subject returns to the clinic after the last dose.

9. Subject and legally authorized representative can read and understand English.

10. Subject's legally authorized representative who signs informed consent is available
to administer all assessments and study medication on days 1 and 2.

Exclusion Criteria:

1. Have any of the following medical conditions: heart disease, high blood pressure,
thyroid disease, diabetes, peripheral vascular disease, increased intraocular
pressure, prostatic hypertrophy

2. Are under treatment for a hyperexcitability disorder with a medication regimen that
has not been stable for at least 3 months

3. Are currently experiencing an asthmatic episode

4. Are experiencing symptoms of seasonal or perennial allergic rhinitis

5. Are currently or within the last 24 hours having symptoms of vomiting or diarrhea

6. Have been exposed to immediate family members with the flu within the past week

7. Are exhibiting signs or symptoms of, or diagnosed with sinusitis, pneumonia, strep
throat, acute otitis media, or influenza

8. Are experiencing a fever 103˚F or higher at screening

9. Are from homes where there is smoking in the home around the child.

10. Are currently taking a monoamine oxidase inhibitor (MAOI), or have taken a MAOI
within two weeks of screening (e.g., isocarboxazid - Marplan, phenelzine - Nardil,
selegiline - Eldepryl, Emsam, Zelapar, and tranylcypromine - Parnate). Note: subjects
may not discontinue taking a MAOI solely of the purposes of qualifying for the study.

11. Have a known sensitivity or allergy to pseudoephedrine, phenylephrine, or
acetaminophen or any of the excipients of the drug product

12. Have taken any oral cold or allergy medicine within 12 hours of enrollment, or
intranasal decongestants within 24 hours of enrollment except for single-ingredient
OTC analgesics

13. Have the need to take additional medications, including cough and cold (i.e., oral or
intranasal antihistamines, intranasal steroids, intranasal decongestants), or
herbal/dietary supplements during the study, with the exception of acetaminophen, a
medication regimen for a hyperexcitability disorder that has been stable for at least
three months or a daily vitamin or multivitamin/multimineral supplement

14. Have participated in another clinical study within 30 days before entry

15. Have another child from the household currently participating in this study

16. Have a history of drug, alcohol, or tobacco use (older children)

17. Are involved directly or indirectly with the conduct and administration of this study
(i.e., children of principal investigator, subinvestigator, study coordinators, other
study personnel, employees of Perrigo, and the families of each).
We found this trial at
Waxahachie, Texas 75165
Principal Investigator: Peggy Linguist, MD
Phone: 972-961-3949
Waxahachie, TX
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Anaheim, California 92804
Principal Investigator: Elizabeth Reyes, MD
Phone: 714-826-8800
Anaheim, CA
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Boise, Idaho 83642
Principal Investigator: John Eck, MD
Phone: 208-377-8653
Boise, ID
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Cleveland, Ohio 44122
Principal Investigator: Holly Dushkin, MD
Phone: 216-682-0320
Cleveland, OH
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Costa Mesa, California 92626
Principal Investigator: Suzanne Kim, MD
Phone: 714-668-1500
Costa Mesa, CA
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Dakota Dunes, South Dakota 57049
Principal Investigator: David Ensz, MD
Phone: 605-232-9000
Dakota Dunes, SD
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Louisville, Kentucky 40291
Principal Investigator: Jeffrey Wampler, MD
Phone: 502-231-1982
Louisville, KY
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Omaha, Nebraska 68134
Principal Investigator: Brandon Essink, MD
Phone: 402-933-6500
Omaha, NE
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Orangeburg, South Carolina 29118
Principal Investigator: John F Ansley, MD
Phone: 803-536-5511
Orangeburg, SC
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St. George, Utah 84790
Principal Investigator: Jonathan P Hubbard, DO
Phone: 435-656-1704
St. George, UT
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West Jordan, Utah 84088
Principal Investigator: Randall Watson, MD
Phone: 801-542-8190
West Jordan, UT
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