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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Nasal Congestion Associated With the Common Cold

Intervention / Treatment
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* Drug: pseudoephedrine hydrochloride 30 mg tablets
* Drug: Placebo tablets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects, ages 6 through 11 years, are experiencing the common cold, but are otherwise healthy. 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). 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. Subjects can swallow oral tablets without chewing them (based on a pretest of successfully swallowing a placebo tablet at screening) Findings from the medical history review and vital signs are within the range of clinical acceptability, as determined by the investigator. Subject and legally authorized representative are likely to be compliant and complete the study. 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 form. 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. Subject and legally authorized representative can read and understand English. 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: Have any of the following medical conditions: heart disease, high blood pressure, thyroid disease, diabetes, peripheral vascular disease, increased intraocular pressure, prostatic hypertrophy Are under treatment for a hyperexcitability disorder with a medication regimen that has not been stable for at least 3 months Are currently experiencing an asthmatic episode Are experiencing symptoms of seasonal or perennial allergic rhinitis Are currently or within the last 24 hours having symptoms of vomiting or diarrhea Have been exposed to immediate family members with the flu within the past week Are exhibiting signs or symptoms of, or diagnosed with sinusitis, pneumonia, strep throat, acute otitis media, or influenza Are experiencing a fever 103˚F or higher at screening Are from homes where there is smoking in the home around the child. 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. Have a known sensitivity or allergy to pseudoephedrine, phenylephrine, or acetaminophen or any of the excipients of the drug product 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 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 Have participated in another clinical study within 30 days before entry Have another child from the household currently participating in this study Have a history of drug, alcohol, or tobacco use (older children) 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).

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pseudoephedrine hydrochloride 30 mg tablets<br>Test product | Drug: pseudoephedrine hydrochloride 30 mg tablets<br> <br> |
| Placebo Comparator: placebo tablets<br>Placebo | Drug: Placebo tablets<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nasal Congestion Severity (NCSi) (instantaneous) scores | Weighted sum of change from baseline in Nasal Congestion Severity (NCSi) (instantaneous) scores over the first eight hours of treatment on Day 1 | 1 Day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in NCSi scores from 0 to 4 hours | Sum of change from baseline in NCSi scores from 0 to 4 hours after the first dose on Day 1 | Day 1 | 
| change from baseline in NCSi scores from 6, 7, and 8 hours | Weighted sum of change from baseline in NCSi scores from 6, 7, and 8 hours after the first dose on Day 1 | Day 1 | 
| Nasal Congestion Relief (NCR) reflective scores at 4 hours and 8 hours | Sum of Nasal Congestion Relief (NCR) reflective scores at 4 hours and 8 hours on Day 1 | Day 1 | 
| NCSi score at each time point from 0 to 8 hours | NCSi score at each time point from 0 to 8 hours after the first dose on Day 1 | Day 1 | 
| NCSr (reflective) scores at 6 hours and 12 hours | Sum of NCSr (reflective) scores at 6 hours and 12 hours on Day 2 | Day 2 | 
| NCSr scores at 6 and 12 hours | NCSr scores at 6 and 12 hours on Day 2 | Day 2 |