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

This study has been completed.
Sponsor:
Collaborators:
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
Pfizer
GlaxoSmithKline
Chattem, Inc.
Information provided by (Responsible Party):
Perrigo Company
ClinicalTrials.gov Identifier:
NCT01744106
First received: December 4, 2012
Last updated: April 20, 2016
Last verified: April 2016
  Purpose
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).

Condition Intervention Phase
Nasal Congestion Associated With the Common Cold
Drug: pseudoephedrine hydrochloride 30 mg tablets
Drug: Placebo tablets
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Placebo-Controlled Study of Pseudoephedrine for the Temporary Relief of Nasal Congestion in Children With the Common Cold

Resource links provided by NLM:


Further study details as provided by Perrigo Company:

Primary Outcome Measures:
  • Nasal Congestion Severity (NCSi) (instantaneous) scores [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
    Weighted sum of change from baseline in Nasal Congestion Severity (NCSi) (instantaneous) scores over the first eight hours of treatment on Day 1


Secondary Outcome Measures:
  • change from baseline in NCSi scores from 0 to 4 hours [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Sum of change from baseline in NCSi scores from 0 to 4 hours after the first dose on Day 1

  • change from baseline in NCSi scores from 6, 7, and 8 hours [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Weighted sum of change from baseline in NCSi scores from 6, 7, and 8 hours after the first dose on Day 1

  • Nasal Congestion Relief (NCR) reflective scores at 4 hours and 8 hours [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Sum of Nasal Congestion Relief (NCR) reflective scores at 4 hours and 8 hours on Day 1

  • NCSi score at each time point from 0 to 8 hours [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    NCSi score at each time point from 0 to 8 hours after the first dose on Day 1

  • NCSr (reflective) scores at 6 hours and 12 hours [ Time Frame: Day 2 ] [ Designated as safety issue: No ]
    Sum of NCSr (reflective) scores at 6 hours and 12 hours on Day 2

  • NCSr scores at 6 and 12 hours [ Time Frame: Day 2 ] [ Designated as safety issue: No ]
    NCSr scores at 6 and 12 hours on Day 2


Other Outcome Measures:
  • change from baseline in the Nasal Symptom and Function (NSF) composite score of NCSi [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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

  • Sum of change from baseline in NSF composite score from 0 to 4 hours [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Sum of change from baseline in NSF composite score from 0 to 4 hours after the first dose on Day 1

  • Weighted sum of change from baseline in NSF composite score from 6, 7, and 8 hours [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Weighted sum of change from baseline in NSF composite score from 6, 7, and 8 hours after the first dose on Day 1

  • morning sleep score on Days 2 through 7 [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
    Change from baseline in morning sleep score on Days 2 through 7

  • NSF composite score on Days 2 through 7 [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
    Change from baseline in NSF composite score on Days 2 through 7

  • NSF + S (sleep) composite score on Days 2 through 7 [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
    Change from baseline in the NSF + S (sleep) composite score on Days 2 through 7


Enrollment: 565
Study Start Date: November 2012
Study Completion Date: April 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: pseudoephedrine hydrochloride 30 mg tablets
Test product
Drug: pseudoephedrine hydrochloride 30 mg tablets
Placebo Comparator: placebo tablets
Placebo
Drug: Placebo tablets

  Eligibility

Ages Eligible for Study:   6 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01744106

Locations
United States, California
Emmaus Research Center
Anaheim, California, United States, 92804
WCCT Global, LLC
Costa Mesa, California, United States, 92626
United States, Idaho
Advanced Clinical Research - Boise
Boise, Idaho, United States, 83642
United States, Kentucky
Bluegrass Clinical Research
Louisville, Kentucky, United States, 40291
United States, Nebraska
Meridian Clinical Research
Omaha, Nebraska, United States, 68134
United States, Ohio
Rapid Medical Research
Cleveland, Ohio, United States, 44122
United States, South Carolina
Carolina Ear, Nose and Throat Clinic
Orangeburg, South Carolina, United States, 29118
United States, South Dakota
Meridian Clinical Research - Dakota Dunes
Dakota Dunes, South Dakota, United States, 57049
United States, Texas
ClinPoint Trials, LLC
Waxahachie, Texas, United States, 75165
United States, Utah
Chrysalis Clinical Research
St. George, Utah, United States, 84790
Advanced Clinical Research - West Jordan
West Jordan, Utah, United States, 84088
Sponsors and Collaborators
Perrigo Company
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
Pfizer
GlaxoSmithKline
Chattem, Inc.
  More Information

Responsible Party: Perrigo Company
ClinicalTrials.gov Identifier: NCT01744106     History of Changes
Other Study ID Numbers: PRGO-PSE-09001 
Study First Received: December 4, 2012
Last Updated: April 20, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Common Cold
Picornaviridae Infections
RNA Virus Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases
Ephedrine
Pseudoephedrine
Adrenergic Agents
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Stimulants
Molecular Mechanisms of Pharmacological Action
Nasal Decongestants
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Sympathomimetics
Therapeutic Uses
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on April 27, 2016