Nasal Congestion Associated With the Common ColdPhase 3NCT01744106
A Multicenter Study of Pseudoephedrine for the Temporary Relief of Nasal Congestion in Children With the Common Cold
A Phase 3 study testing pseudoephedrine hydrochloride 30 mg tablets in people with Nasal Congestion Associated With the Common Cold, run by Perrigo Company at 11 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Nasal Congestion Associated With the Common Cold
- What is being tested?
- pseudoephedrine hydrochloride 30 mg tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 565 participants
- Where
- 11 sitesUnited States
- Study dates
- Nov 2012to Apr 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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
- Have a history of drug, alcohol, or tobacco use (older children)
- 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).
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Emmaus Research Center
Anaheim, California, 92804
Advanced Clinical Research - Boise
Boise, Idaho, 83642
Rapid Medical Research
Cleveland, Ohio, 44122
WCCT Global, LLC
Costa Mesa, California, 92626
Meridian Clinical Research - Dakota Dunes
Dakota Dunes, South Dakota, 57049
Bluegrass Clinical Research
Louisville, Kentucky, 40291
Meridian Clinical Research
Omaha, Nebraska, 68134
Carolina Ear, Nose and Throat Clinic
Orangeburg, South Carolina, 29118
Chrysalis Clinical Research
St. George, Utah, 84790
ClinPoint Trials, LLC
Waxahachie, Texas, 75165
Advanced Clinical Research - West Jordan
West Jordan, Utah, 84088
About this study
Official title: 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).
- Being tested
- pseudoephedrine hydrochloride 30 mg tablets, Placebo tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pseudoephedrine hydrochloride 30 mg tabletsDrug
Placebo tabletsDrug
| Study group | Role | What they receive |
|---|---|---|
| pseudoephedrine hydrochloride 30 mg tablets | Experimental | Test product Receives: Drug: pseudoephedrine hydrochloride 30 mg tablets |
| placebo tablets | Placebo comparator | Placebo Receives: Drug: Placebo tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 Day
Secondary outcomes (6)
change from baseline in NCSi scores from 0 to 4 hours
Sum of change from baseline in NCSi scores from 0 to 4 hours after the first dose on Day 1
Measured: Day 1
change from baseline in NCSi scores from 6, 7, and 8 hours
Weighted sum of change from baseline in NCSi scores from 6, 7, and 8 hours after the first dose on Day 1
Measured: Day 1
Nasal Congestion Relief (NCR) reflective scores at 4 hours and 8 hours
Sum of Nasal Congestion Relief (NCR) reflective scores at 4 hours and 8 hours on Day 1
Measured: Day 1
NCSi score at each time point from 0 to 8 hours
NCSi score at each time point from 0 to 8 hours after the first dose on Day 1
Measured: Day 1
NCSr (reflective) scores at 6 hours and 12 hours
Sum of NCSr (reflective) scores at 6 hours and 12 hours on Day 2
Measured: Day 2
NCSr scores at 6 and 12 hours
NCSr scores at 6 and 12 hours on Day 2
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal Congestion Associated With the Common ColdStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 565 participants (actual)
Sponsor and investigators
- Lead sponsor
- Perrigo Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- McNeil Consumer Healthcare Division of McNEIL-PPC, Inc., Pfizer, GlaxoSmithKline, Chattem, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01744106
- Sponsor's protocol ID
- PRGO-PSE-09001
- Status last verified
- Apr 2016
- First submitted
- 4 Dec 2012
- Last updated
- 22 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Placebo-Controlled Study of Pseudoephedrine for the Temporary Relief of Nasal Congestion in Children With the Common Cold
- ClinicalTrials.gov ID
- NCT01744106
- Acronym / sponsor ID
- PRGO-PSE-09001
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 565 participants (actual)
- Lead sponsor
- Perrigo CompanyIndustry (pharma, biotech, devices)
- Collaborators
- McNeil Consumer Healthcare Division of McNEIL-PPC, Inc., Pfizer, GlaxoSmithKline, Chattem, Inc.
- Study start
- Nov 2012
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 6 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pseudoephedrine hydrochloride 30 mg tablets | Experimental | Drug: pseudoephedrine hydrochloride 30 mg tabletsTest product |
| placebo tablets | Placebo comparator | Drug: Placebo tabletsPlacebo |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pseudoephedrine hydrochloride 30 mg tablets | Drug | pseudoephedrine hydrochloride 30 mg tablets |
| Placebo tablets | Drug | placebo tablets |
Primary outcome
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
6 secondary outcomes
change from baseline in NCSi scores from 0 to 4 hours
Time frame: Day 1
change from baseline in NCSi scores from 6, 7, and 8 hours
Time frame: Day 1
Nasal Congestion Relief (NCR) reflective scores at 4 hours and 8 hours
Time frame: Day 1
NCSi score at each time point from 0 to 8 hours
Time frame: Day 1
NCSr (reflective) scores at 6 hours and 12 hours
Time frame: Day 2
NCSr scores at 6 and 12 hours
Time frame: Day 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing pseudoephedrine hydrochloride 30 mg tablets in people with Nasal Congestion Associated With the Common Cold, run by Perrigo Company at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nasal Congestion Severity (NCSi) (instantaneous) scores (time frame: 1 Day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2016.