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

Information source: Perrigo Company
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Nasal Congestion Associated With the Common Cold

Intervention: pseudoephedrine hydrochloride 30 mg tablets (Drug); Placebo tablets (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Perrigo Company


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).

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Nasal Congestion Severity (NCSi) (instantaneous) scores

Secondary outcome:

change from baseline in NCSi scores from 0 to 4 hours

change from baseline in NCSi scores from 6, 7, and 8 hours

Nasal Congestion Relief (NCR) reflective scores at 4 hours and 8 hours

NCSi score at each time point from 0 to 8 hours

NCSr (reflective) scores at 6 hours and 12 hours

NCSr scores at 6 and 12 hours


Minimum age: 6 Years. Maximum age: 11 Years. Gender(s): Both.


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 form. 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).

Locations and Contacts

Emmaus Research Center, Anaheim, California 92804, United States; Recruiting
Filipinas Vitug, Phone: 714-826-8800

WCCT Global, LLC, Costa Mesa, California 92626, United States; Recruiting
Anoshie Ratnayake, MD, Phone: 714-668-1500

Concentrics Center for Research, Indianapolis, Indiana 46240, United States; Recruiting
Sara Dugdale, Phone: 317-706-3212

Central Kentucky Research Associates, Inc., Lexington, Kentucky 40509, United States; Recruiting
Erica Jones, Phone: 859-264-8999

MedPharmics, LLC, Metairie, Louisiana 70006, United States; Recruiting
Robert Jeanfreau, MD, Phone: 504-265-9951

Montana Medical Research, Inc., Missoula, Montana 59808, United States; Recruiting
Carl Thornblade, MD, Phone: 406-549-1124

Meridian Clinical Research, Omaha, Nebraska 68134, United States; Recruiting
Laura Falcone, Phone: 402-933-6500

Sterling Research Group, Ltd., Cincinnati, Ohio 45246, United States; Recruiting
Julie Mullen, DO, Phone: 513-671-8080

Toledo Institute of Clinical Research, Toledo, Ohio 43617, United States; Recruiting
Syed Rehman, MD, Phone: 419-843-8815

Carolina Ear, Nose and Throat Clinic, Orangeburg, South Carolina 29118, United States; Recruiting
Simone Ansley, Phone: 803-536-5511

ClinPoint Trials, LLC, Waxahachie, Texas 75165, United States; Recruiting
Peggy Linguist, MD, Phone: 972-961-3949

Chrysalis Clinical Research, St. George, Utah 84790, United States; Recruiting
Jonathan Hubbard, DO, Phone: 435-656-1704

Allergy, Asthma & Sinus Center, Greenfield, Wisconsin 53228, United States; Recruiting
Gary Steven, MD, Phone: 414-529-8519

Additional Information

Starting date: November 2012
Last updated: July 1, 2015

Page last updated: August 20, 2015

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