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

April 20, 2016 updated by: Perrigo Company

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
565

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Nasal Congestion Severity (NCSi) (instantaneous) scores
Time Frame: 1 Day
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
change from baseline in NCSi scores from 0 to 4 hours
Time Frame: Day 1
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
Time Frame: Day 1
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
Time Frame: Day 1
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
Time Frame: Day 1
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
Time Frame: Day 2
Sum of NCSr (reflective) scores at 6 hours and 12 hours on Day 2
Day 2
NCSr scores at 6 and 12 hours
Time Frame: Day 2
NCSr scores at 6 and 12 hours on Day 2
Day 2

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
change from baseline in the Nasal Symptom and Function (NSF) composite score of NCSi
Time Frame: Day 1
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
Time Frame: Day 1
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
Time Frame: Day 1
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
Time Frame: Day 7
Change from baseline in morning sleep score on Days 2 through 7
Day 7
NSF composite score on Days 2 through 7
Time Frame: Day 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
Time Frame: Day 7
Change from baseline in the NSF + S (sleep) composite score on Days 2 through 7
Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Perrigo Company

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
GlaxoSmithKline
Pfizer
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
Chattem, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 4, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 6, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 22, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PRGO-PSE-09001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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