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

NCT01744106 | Completed Phase 3

• 1 other identifier: PRGO-PSE-09001
• Study Type: interventional
• Target: 565
• Locations: 1 country
• Sites: 11

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).

Conditions

Nasal Congestion Associated With the Common Cold

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• change from baseline in NCSi scores from 0 to 4 hours

  Day 1

• change from baseline in NCSi scores from 6, 7, and 8 hours

  Day 1

• Nasal Congestion Relief (NCR) reflective scores at 4 hours and 8 hours

  Day 1

• NCSi score at each time point from 0 to 8 hours

  Day 1

• NCSr (reflective) scores at 6 hours and 12 hours

  Day 2

Other Outcomes (6)

• change from baseline in the Nasal Symptom and Function (NSF) composite score of NCSi

  Day 1

• Sum of change from baseline in NSF composite score from 0 to 4 hours

  Day 1

• Weighted sum of change from baseline in NSF composite score from 6, 7, and 8 hours

  Day 1

Study Arms (2)

pseudoephedrine hydrochloride 30 mg tablets

EXPERIMENTAL

Test product

Drug: pseudoephedrine hydrochloride 30 mg tablets

placebo tablets

PLACEBO COMPARATOR

Placebo

Drug: Placebo tablets

Interventions

pseudoephedrine hydrochloride 30 mg tablets DRUG

pseudoephedrine hydrochloride 30 mg tablets

Placebo tablets DRUG

placebo tablets

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male or female subjects, ages 6 through 11 years, are experiencing the common cold, but are otherwise healthy.
• 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).
• 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.
• Subjects can swallow oral tablets without chewing them (based on a pretest of successfully swallowing a placebo tablet at screening)
• Findings from the medical history review and vital signs are within the range of clinical acceptability, as determined by the investigator.
• Subject and legally authorized representative are likely to be compliant and complete the study.
• 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.
• 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.
• Subject and legally authorized representative can read and understand English.
• Subject's legally authorized representative who signs informed consent is available to administer all assessments and study medication on days 1 and 2.

You may not qualify if:

• Have any of the following medical conditions: heart disease, high blood pressure, thyroid disease, diabetes, peripheral vascular disease, increased intraocular pressure, prostatic hypertrophy
• Are under treatment for a hyperexcitability disorder with a medication regimen that has not been stable for at least 3 months
• Are currently experiencing an asthmatic episode
• Are experiencing symptoms of seasonal or perennial allergic rhinitis
• Are currently or within the last 24 hours having symptoms of vomiting or diarrhea
• Have been exposed to immediate family members with the flu within the past week
• Are exhibiting signs or symptoms of, or diagnosed with sinusitis, pneumonia, strep throat, acute otitis media, or influenza
• Are experiencing a fever 103˚F or higher at screening
• Are from homes where there is smoking in the home around the child.
• 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.
• Have a known sensitivity or allergy to pseudoephedrine, phenylephrine, or acetaminophen or any of the excipients of the drug product
• 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
• 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
• Have participated in another clinical study within 30 days before entry
• Have another child from the household currently participating in this study

Sponsors & Collaborators

• Perrigo Company: lead
• McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.: collaborator
• Pfizer: collaborator
• GlaxoSmithKline: collaborator
• Chattem, Inc.: collaborator

Study Sites (11)

Emmaus Research Center

Anaheim, California, 92804, United States

Location

WCCT Global, LLC

Costa Mesa, California, 92626, United States

Location

Advanced Clinical Research - Boise

Boise, Idaho, 83642, United States

Location

Bluegrass Clinical Research

Louisville, Kentucky, 40291, United States

Location

Meridian Clinical Research

Omaha, Nebraska, 68134, United States

Location

Rapid Medical Research

Cleveland, Ohio, 44122, United States

Location

Carolina Ear, Nose and Throat Clinic

Orangeburg, South Carolina, 29118, United States

Location

Meridian Clinical Research - Dakota Dunes

Dakota Dunes, South Dakota, 57049, United States

Location

ClinPoint Trials, LLC

Waxahachie, Texas, 75165, United States

Location

Chrysalis Clinical Research

St. George, Utah, 84790, United States

Location

Advanced Clinical Research - West Jordan

West Jordan, Utah, 84088, United States

Location

MeSH Terms

Interventions

Pseudoephedrine

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Phenethylamines; Ethylamines

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2012
• First Posted: December 6, 2012
• Study Start: November 1, 2012
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: April 22, 2016

Record last verified: 2016-04

Locations

US (11)