Clinical trial NCT01744106: A Multicenter Study of Pseudoephedrine for the Temporary Relief of Nasal Congestion in Children With the Common Cold
Official title: A Multicenter, Randomized, Placebo-Controlled Study of Pseudoephedrine for the Temporary Relief of Nasal Congestion in Children With the Common Cold
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Nasal Congestion Associated With the Common Cold
Lead sponsor: Perrigo Company
Sponsor class: INDUSTRY
Collaborators: name: McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
name: Pfizer
name: GlaxoSmithKline
name: Chattem, Inc.
First posted: 2012-12-06
Enrollment: 565
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility 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).

Primary outcomes:
measure: Nasal Congestion Severity (NCSi) (instantaneous) scores
timeFrame: 1 Day
Secondary outcomes:
measure: change from baseline in NCSi scores from 0 to 4 hours
timeFrame: Day 1
measure: change from baseline in NCSi scores from 6, 7, and 8 hours
timeFrame: Day 1
measure: Nasal Congestion Relief (NCR) reflective scores at 4 hours and 8 hours
timeFrame: Day 1
measure: NCSi score at each time point from 0 to 8 hours
timeFrame: Day 1
measure: NCSr (reflective) scores at 6 hours and 12 hours
timeFrame: Day 2
measure: NCSr scores at 6 and 12 hours
timeFrame: Day 2
Other outcomes:
measure: change from baseline in the Nasal Symptom and Function (NSF) composite score of NCSi
timeFrame: Day 1
measure: Sum of change from baseline in NSF composite score from 0 to 4 hours
timeFrame: Day 1
measure: Weighted sum of change from baseline in NSF composite score from 6, 7, and 8 hours
timeFrame: Day 1
measure: morning sleep score on Days 2 through 7
timeFrame: Day 7
measure: NSF composite score on Days 2 through 7
timeFrame: Day 7
measure: NSF + S (sleep) composite score on Days 2 through 7
timeFrame: Day 7
Locations:
city: Anaheim
country: United States
facility: Emmaus Research Center
state: California
city: Costa Mesa
country: United States
facility: WCCT Global, LLC
state: California
city: Boise
country: United States
facility: Advanced Clinical Research - Boise
state: Idaho
city: Louisville
country: United States
facility: Bluegrass Clinical Research
state: Kentucky
city: Omaha
country: United States
facility: Meridian Clinical Research
state: Nebraska
city: Cleveland
country: United States
facility: Rapid Medical Research
state: Ohio
city: Orangeburg
country: United States
facility: Carolina Ear, Nose and Throat Clinic
state: South Carolina
city: Dakota Dunes
country: United States
facility: Meridian Clinical Research - Dakota Dunes
state: South Dakota
city: Waxahachie
country: United States
facility: ClinPoint Trials, LLC
state: Texas
city: St. George
country: United States
facility: Chrysalis Clinical Research
state: Utah
city: West Jordan
country: United States
facility: Advanced Clinical Research - West Jordan
state: Utah
Study officials:
References: