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

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).

Study Overview

• Status: Completed
• Conditions: Nasal Congestion Associated With the Common Cold
• Intervention / Treatment: Drug: Placebo tablets; Drug: pseudoephedrine hydrochloride 30 mg tablets

• Study Type: Interventional
• Enrollment (Actual): 565
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92804
      • Emmaus Research Center
    • Costa Mesa, California, United States, 92626
      • WCCT Global, LLC
  • Idaho
    • Boise, Idaho, United States, 83642
      • Advanced Clinical Research - Boise
  • Kentucky
    • Louisville, Kentucky, United States, 40291
      • Bluegrass Clinical Research
  • Nebraska
    • Omaha, Nebraska, United States, 68134
      • Meridian Clinical Research
  • Ohio
    • Cleveland, Ohio, United States, 44122
      • Rapid Medical Research
  • South Carolina
    • Orangeburg, South Carolina, United States, 29118
      • Carolina Ear, Nose and Throat Clinic
  • South Dakota
    • Dakota Dunes, South Dakota, United States, 57049
      • Meridian Clinical Research - Dakota Dunes
  • Texas
    • Waxahachie, Texas, United States, 75165
      • ClinPoint Trials, LLC
  • Utah
    • St. George, Utah, United States, 84790
      • Chrysalis Clinical Research
    • West Jordan, Utah, United States, 84088
      • Advanced Clinical Research - West Jordan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: pseudoephedrine hydrochloride 30 mg tablets; Test product	Drug: pseudoephedrine hydrochloride 30 mg tablets
Placebo Comparator: placebo tablets; Placebo	Drug: Placebo tablets

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
change from baseline in the Nasal Symptom and Function (NSF) composite score of NCSi	Weighted sum of change from baseline in the Nasal Symptom and Function (NSF) composite score of NCSi, nasal breathing, and nasal clearing over the first eight hours of treatment on Day 1	Day 1
Sum of change from baseline in NSF composite score from 0 to 4 hours	Sum of change from baseline in NSF composite score from 0 to 4 hours after the first dose on Day 1	Day 1
Weighted sum of change from baseline in NSF composite score from 6, 7, and 8 hours	Weighted sum of change from baseline in NSF composite score from 6, 7, and 8 hours after the first dose on Day 1	Day 1
morning sleep score on Days 2 through 7	Change from baseline in morning sleep score on Days 2 through 7	Day 7
NSF composite score on Days 2 through 7	Change from baseline in NSF composite score on Days 2 through 7	Day 7
NSF + S (sleep) composite score on Days 2 through 7	Change from baseline in the NSF + S (sleep) composite score on Days 2 through 7	Day 7

Collaborators and Investigators

• Sponsor: Perrigo Company
• Collaborators: GlaxoSmithKline; Pfizer; McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.; Chattem, Inc.

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: December 4, 2012
• First Submitted That Met QC Criteria: December 5, 2012
• First Posted (Estimate): December 6, 2012

Study Record Updates

• Last Update Posted (Estimate): April 22, 2016
• Last Update Submitted That Met QC Criteria: April 20, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Picornaviridae Infections; Common Cold; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Central Nervous System Stimulants; Sympathomimetics; Vasoconstrictor Agents; Nasal Decongestants; Ephedrine; Pseudoephedrine
• Other Study ID Numbers: PRGO-PSE-09001