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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Perrigo Company
Sponsor:
Collaborators:
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
Pfizer
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Perrigo Company
ClinicalTrials.gov Identifier:
NCT01744106
First received: December 4, 2012
Last updated: March 25, 2014
Last verified: March 2014
  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


Estimated Enrollment: 560
Study Start Date: November 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (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, Alabama
Clinical Research Center of Alabama Recruiting
Birmingham, Alabama, United States, 35209
Contact: Helen Combs    205-871-9661      
United States, Arkansas
HealthStar Research, LLC Recruiting
Hot Springs, Arkansas, United States, 71913
Contact: Tempa Moore    501-760-2903      
United States, California
Emmaus Research Center Recruiting
Anaheim, California, United States, 92804
Contact: Filipinas Vitug    714-826-8800      
Benchmark Research, Sacramento Recruiting
Sacramento, California, United States, 95822
Contact: Jessica Sullivan    916-452-5830      
Benchmark Research, San Fran Recruiting
San Francisco, California, United States, 94102
Contact: Leigh Shinn    415-398-0173      
United States, Florida
DMI Research Recruiting
Pinellas Park, Florida, United States, 33782
Contact: Kathy Hann    727-531-2848      
United States, Indiana
Concentrics Center for Research Recruiting
Indianapolis, Indiana, United States, 46240
Contact: Sara Dugdale    317-706-3212      
United States, Kentucky
Central Kentucky Research Associates, Inc. Recruiting
Lexington, Kentucky, United States, 40509
Contact: Erica Jones    859-264-8999      
United States, Nebraska
Meridian Clinical Research Recruiting
Omaha, Nebraska, United States, 68134
Contact: Laura Falcone    402-933-6500      
United States, New York
United Medical Research, Inc. Recruiting
Binghamton, New York, United States, 13901
Contact: Deborah Hubish    607-771-1064 ext 1344      
United States, South Carolina
National Allergy, Asthma and Urticaria Centers of Charleston, P.A. Recruiting
N. Charleston, South Carolina, United States, 29406
Contact: Karen Case    843-820-1036      
Carolina Ear, Nose and Throat Clinic Recruiting
Orangeburg, South Carolina, United States, 29118
Contact: Simone Ansley    803-536-5511      
United States, Texas
Benchmark Research, Austin Recruiting
Austin, Texas, United States, 78705
Contact: Pamela Conley    512-478-5416      
Benchmark Research, San Angelo Recruiting
San Angelo, Texas, United States, 76904
Contact: Krystal Doucet    325-716-1355      
United States, Virginia
Clinical Research Associates of Tidewater, Inc Recruiting
Norfolk, Virginia, United States, 23507
Contact: Edith Wombolt    757-627-7446      
Sponsors and Collaborators
Perrigo Company
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
Pfizer
Novartis Pharmaceuticals
  More Information

No publications provided

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: March 25, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 19, 2014