Common ColdPhase 2PIERNCT03339726

Randomized, Double-blind, Placebo-Controlled, Efficacy Study of a New Formulation of Phenylephrine HCL in the Common Cold

A Phase 2 study testing New Formulation Phenylephrine HCl and Marketed Phenylephrine HCl in people with Common Cold, run by Johnson & Johnson Consumer Inc. (J&JCI) at 11 sites in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This will be a randomized, double-blind, placebo controlled, parallel-group Phase 2 study to evaluate the efficacy of a new formulation of phenylephrine HCl and a currently marketed phenylephrine HCl for relief of nasal congestion in subjects with naturally occurring cold symptoms. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Common Cold
What is being tested?: New Formulation Phenylephrine HCl and Marketed Phenylephrine HCl
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 193 participants
Where: 11 sitesCanada
Study dates: 30 Nov 2017to 16 Apr 2018
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

None listed.

Who cannot join

Currently experiencing nasal congestion due to allergic rhinitis or chronic respiratory disease.
Any ear, nose, throat, or respiratory tract disease, other than the common cold, identified by signs and symptoms reported by the subject, or by medical history or medication history
Presence of asthma.
History of rhinitis medicamentosa, anatomical nasal obstruction or deformity, nasal reconstructive surgery, or chronic sleep apnea.
Fever of ≥ 101.0 °F (38.3 °C).
Heart disease, controlled or uncontrolled hypertension, thyroid disease, diabetes, glaucoma, prostatic hypertrophy, or presence of a disease, which in the opinion of the investigator, would preclude the use of phenylephrine.

Show all 26Show fewer

Are currently taking, or have taken within two weeks of screening, a monoamine oxidase inhibitor (MAOI).
Have the need to use medications which may impact nasal symptomatology i.e. systemic, inhaled (oral or nasal) corticosteroids, and the following drugs with significant anticholinergic properties: tricyclic antidepressants, paroxetine, medicines used to treat overactive bladder, antipsychotic medication, skeletal muscle relaxants, antiparkinsonian medication, the anticonvulsants carbamazepine and oxcarbazepine, and dicycloverine (dicyclomine), dimenhydrinate, propantheline, atropine, hyoscyamine, belladonna, prochlorperazine and promethazine.
Have a bacterial sinus infection within 2 weeks prior to screening.
Use of systemic antibiotics within the past 7 days prior to screening.
Known or suspected alcohol or substance abuse (e.g., amphetamines, benzodiazepines, cocaine, marijuana, opiates).
Use of marijuana containing substances within the 10 days prior to screening and throughout the study.
Positive Urine Drug Screen.
Use of alcohol throughout the study.
History of smoking tobacco products or use of nicotine-containing substances within the previous three months as determined by subject's medical history or subject's verbal report.
Known sensitivity to the investigational product or any excipients of the drug product.
Before the first dose of study medicine, use of
oral or intranasal cold, cough, allergy, or analgesic/antipyretic medicines within approximately 12 hours;
menthol products, medicated lozenge, humidifier, nasal saline spray or throat spray within approximately 6 hours;
herbal/dietary supplements within approximately 12 hours.
Have difficulty swallowing tablets/capsules or are unable to swallow whole without crushing, chewing, splitting, or dissolving.
Subjects who were previously randomized and received the IP.
Significant unstable or uncontrolled medical condition that may interfere with a subject's participation in the study.
Other severe, acute or chronic, medical or psychiatric condition(s) or laboratory abnormality that may increase the risk associated with study participation or IP administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Currently participating in another clinical trial or has done so in the past 30 days.
Subjects who are related to those persons involved directly or indirectly with the conduct of this study (i.e., principal investigator, sub-investigators, study coordinators, other site personnel, employees of Johnson \& Johnson (J\&J) subsidiaries, contractors of J\&J, and the families of each).

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

Canada11 sites

NEOMO Research
Greater Sudbury, Ontario, P3E 6C3
Dawson Road Family Medical Clinic
Guelph, Ontario, N1H 1B1
The Medical Arts Health Research Group
Kelowna, British Columbia, V1Y 4N7
Sunningdale Health and Wellness Centre
London, Ontario, N6G 4W3
Mission Hills Urgent Care Walk in Clinic
Mission, British Columbia, V2V 0C8
Bluewater Clinical Research Group, Inc.
Sarnia, Ontario, N7T 4X3
Diex Recherche
Sherbrooke, Quebec, J1H 1Z1
Canadian Phase Onward, Inc.
Toronto, Ontario, M3J 2C5
PrimeHealth Clinical Research
Toronto, Ontario, M4S 1Y2
James Lai, MD, Inc
Vancouver, British Columbia
Diex Recherche
Victoriaville, Quebec, G6P 6P6

Other trials in Canada

About this study

Official title: Randomized, Double-blind, Placebo-Controlled Study of the Efficacy of Phenylephrine HCL Extended-Release 30 mg and Phenylephrine HCL Immediate-Release 12 mg Capsules in Subjects With Nasal Congestion Due to the Common Cold

Conditions: Common Cold
Being tested: New Formulation Phenylephrine HCl, Marketed Phenylephrine HCl, Placebo
Medical subject headings: Common Cold

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

New Formulation Phenylephrine HClDrug
2 doses of one tablet 12 hours apart
Marketed Phenylephrine HClDrug
4 doses of one capsule 4 hours apart
PlaceboDrug
4 doses of placebo capsule and tablet taken 4 hours apart

Study groups in NCT03339726
Study group	Role	What they receive
New Formulation Phenylephrine HCl	Experimental	Not described Receives: Drug: New Formulation Phenylephrine HCl
Marketed Phenylephrine HCl	Active comparator	Not described Receives: Drug: Marketed Phenylephrine HCl
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Change From Baseline in the Nasal Congestion Severity Score
Average change from baseline in the Nasal Congestion Severity Score on an 8 point scale with 0=None and 7=Severe. Change from baseline in the Nasal Congestion Severity Score averaged over assessments at 2, 4, 6, 8, 10, and 12 hours.
Measured: 0-12 hours

Secondary outcomes (16)

Average Change From Baseline in the Nasal Congestion Severity Score
Average change from baseline in the Nasal Congestion Severity Score averaged over hours 8-12. This is an 8 point scale with 0=None and 7=Severe.
Measured: 0-12 hours
Change From Baseline in the Nasal Congestion Severity Score
Change from baseline in the Nasal Congestion Severity Score at 2 hours. This is an 8 point scale with 0=None and 7=Severe.
Measured: 0-2 hours
Change From Baseline in the Nasal Congestion Severity Score
Change from baseline in the Nasal Congestion Severity Score at 4 hours. This is an 8 point scale with 0=None and 7=Severe.
Measured: 0-4 hours
Change From Baseline in the Nasal Congestion Severity Score
Change from baseline in the Nasal Congestion Severity Score at 6 hours. This is an 8 point scale with 0=None and 7=Severe.
Measured: 0-6 hours
Change From Baseline in the Nasal Congestion Severity Score
Change from baseline in the Nasal Congestion Severity Score at 8 hours. This is an 8 point scale with 0=None and 7=Severe.
Measured: 0-8 hours
Change From Baseline in the Nasal Congestion Severity Score
Change from baseline in the Nasal Congestion Severity Score at 10 hours. This is an 8 point scale with 0=None and 7=Severe.
Measured: 0-10 hours
Change From Baseline in the Nasal Congestion Severity Score
Change from baseline in the Nasal Congestion Severity Score at 12 hours. This is an 8 point scale with 0=None and 7=Severe.
Measured: 0-12 hours
Change From Baseline in the Nasal Congestion Severity Score
Change from baseline in the Nasal Congestion Severity Score at 24 hours. This is an 8 point scale with 0=None and 7=Severe.
Measured: 0-24 hours
Average Change From Baseline in Sinus Pressure/Tenderness Scores
Change from baseline in Sinus Pressure/Tenderness Scores averaged over assessments at 2, 4, 6, 8, 10, and 12 hours. This is an 8 point scale with 0=None and 7=Severe.
Measured: 0-12 hours
Change From Baseline in Sinus Pressure/Tenderness Scores
Change from baseline in Sinus Pressure/Tenderness Scores at 2 hours. This is an 8 point scale with 0=None and 7=Severe.
Measured: 0-2 hours
Change From Baseline in Sinus Pressure/Tenderness Scores
Change from baseline in Sinus Pressure/Tenderness Scores at 4 hours.
Measured: 0-4 hours
Change From Baseline in Sinus Pressure/Tenderness Scores
Change from baseline in Sinus Pressure/Tenderness Scores at 6 hours. This is an 8 point scale with 0=None and 7=Severe.
Measured: 0-6 hours
Change From Baseline in Sinus Pressure/Tenderness Scores
Change from baseline in Sinus Pressure/Tenderness Scores at 8 hours. This is an 8 point scale with 0=None and 7=Severe.
Measured: 0-8 hours
Change From Baseline in Sinus Pressure/Tenderness Scores
Change from baseline in Sinus Pressure/Tenderness Scores at 10 hours. This is an 8 point scale with 0=None and 7=Severe.
Measured: 0-10 hours
Change From Baseline in Sinus Pressure/Tenderness Scores
Change from baseline in Sinus Pressure/Tenderness Scores at 12 hours. This is an 8 point scale with 0=None and 7=Severe.
Measured: 0-12 hours
Change From Baseline in Sinus Pressure/Tenderness Scores
Change from baseline in Sinus Pressure/Tenderness Scores at 24 hours. This is an 8 point scale with 0=None and 7=Severe.
Measured: 0-24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Nov 201716 Apr 2018

First posted13 Nov 2017
Study start30 Nov 2017
Primary completion16 Apr 2018
Study completion16 Apr 2018

Why it stopped: did not enroll enough subjects in the 2017/2018 cold season, so the study was terminated

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 193 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03339726
Sponsor's protocol ID: CO-170302131230-URCT
Acronym: PIER
Status last verified: Jun 2019
First submitted: 8 Nov 2017
Last updated: 4 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Not yet recruitingObservational study
Post-market Clinical Follow-up Study of an Isotonic Saline Solution for the Relief of Nasal Congestion in Infants and Toddlers
Nasal Congestion, Common Cold
Recruiting
Effect of Immune X on Common Cold Incidence in Healthy Adults
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Recruiting
Omega-Cold Supplementation With Free Fatty Acids for the Prevention of Respiratory Infections in Adults.
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Recruiting
Safety and Performance Assessment of the Decongestant Seawater Spray Pocket Valve Enriched With Essential Oils in Patients With Acute Rhinitis Associated With Nasal Obstruction: "DEVALPO"
Acute Rhinitis, Nasal Obstruction

All Common Cold trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Double-blind, Placebo-Controlled Study of the Efficacy of Phenylephrine HCL Extended-Release 30 mg and Phenylephrine HCL Immediate-Release 12 mg Capsules in Subjects With Nasal Congestion Due to the Common Cold
ClinicalTrials.gov ID: NCT03339726
Acronym / sponsor ID: PIER / CO-170302131230-URCT
Conditions: Common Cold
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: did not enroll enough subjects in the 2017/2018 cold season, so the study was terminated
Enrolment: 193 participants (actual)
Lead sponsor: Johnson & Johnson Consumer Inc. (J&JCI)Industry (pharma, biotech, devices)
Study start: 30 Nov 2017 (actual)
Primary completion: 16 Apr 2018 (actual)
Study completion: 16 Apr 2018 (actual)
First posted: 13 Nov 2017 (actual)
Results: Posted 4 Jun 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
New Formulation Phenylephrine HCl	Experimental	Drug: New Formulation Phenylephrine HCl
Marketed Phenylephrine HCl	Active comparator	Drug: Marketed Phenylephrine HCl
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (0 listed)

Key exclusion criteria (26 listed)

Currently experiencing nasal congestion due to allergic rhinitis or chronic respiratory disease.
Any ear, nose, throat, or respiratory tract disease, other than the common cold, identified by signs and symptoms reported by the subject, or by medical history or medication history
Presence of asthma.
History of rhinitis medicamentosa, anatomical nasal obstruction or deformity, nasal reconstructive surgery, or chronic sleep apnea.
Fever of ≥ 101.0 °F (38.3 °C).

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
New Formulation Phenylephrine HCl2 doses of one tablet 12 hours apart	Drug	New Formulation Phenylephrine HCl
Marketed Phenylephrine HCl4 doses of one capsule 4 hours apart	Drug	Marketed Phenylephrine HCl
Placebo4 doses of placebo capsule and tablet taken 4 hours apart	Drug	Placebo

Primary outcome

Mean Change From Baseline in the Nasal Congestion Severity Score
Time frame: 0-12 hours
Average change from baseline in the Nasal Congestion Severity Score on an 8 point scale with 0=None and 7=Severe. Change from baseline in the Nasal Congestion Severity Score averaged over assessments at 2, 4, 6, 8, 10, and 12 hours.

16 secondary outcomes

Average Change From Baseline in the Nasal Congestion Severity Score
Time frame: 0-12 hours
Change From Baseline in the Nasal Congestion Severity Score
Time frame: 0-2 hours
Change From Baseline in the Nasal Congestion Severity Score
Time frame: 0-4 hours
Change From Baseline in the Nasal Congestion Severity Score
Time frame: 0-6 hours
Change From Baseline in the Nasal Congestion Severity Score
Time frame: 0-8 hours
Change From Baseline in the Nasal Congestion Severity Score
Time frame: 0-10 hours
Change From Baseline in the Nasal Congestion Severity Score
Time frame: 0-12 hours
Change From Baseline in the Nasal Congestion Severity Score
Time frame: 0-24 hours
Average Change From Baseline in Sinus Pressure/Tenderness Scores
Time frame: 0-12 hours
Change From Baseline in Sinus Pressure/Tenderness Scores
Time frame: 0-2 hours
Change From Baseline in Sinus Pressure/Tenderness Scores
Time frame: 0-4 hours
Change From Baseline in Sinus Pressure/Tenderness Scores
Time frame: 0-6 hours
Change From Baseline in Sinus Pressure/Tenderness Scores
Time frame: 0-8 hours
Change From Baseline in Sinus Pressure/Tenderness Scores
Time frame: 0-10 hours
Change From Baseline in Sinus Pressure/Tenderness Scores
Time frame: 0-12 hours
Change From Baseline in Sinus Pressure/Tenderness Scores
Time frame: 0-24 hours

Results and safety

Results posted to the registry on 4 Jun 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	64	63
PE-IR	66	65
PE-ER	63	63

Primary outcome: Mean Change From Baseline in the Nasal Congestion Severity Score

Time frame: 0-12 hours. Mean (Standard Error). Unit: units on a scale

Measure	Placebo n = 64	PE-IR n = 66	PE-ER n = 63
Value	1.80 (0.156)	2.03 (0.154)	1.93 (0.158)

Placebo vs PE-IR: Mean Difference (Final Values): 0.23 (95% CI -0.205 to 0.662), p = 0.300, ANOVA
Placebo vs PE-ER: Mean Difference (Final Values): 0.13 (95% CI -0.311 to 0.564), p = 0.569, ANOVA
PE-IR vs PE-ER: Mean Difference (Final Values): -0.10 (95% CI -0.537 to 0.333), p = 0.645, ANOVA

Population analysed: Analysis is based on the Full Analysis Set population, which included all participants who were randomized and provided a valid baseline assessment of nasal congestion severity.

16 secondary outcomes are reported in the full results.

Adverse events

Time frame: Within three days for nonserious adverse events, +30 days after the participant's last dose or exposure to the investigational product for serious adverse events.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 64 (0%)	0 of 64 (0%)	0 of 64
PE-IR	0 of 66 (0%)	0 of 66 (0%)	0 of 66
PE-ER	0 of 63 (0%)	0 of 63 (0%)	0 of 63

Limitations and caveats (from the sponsor): An interim statistical analysis was conducted after the study failed to meet planned enrollment in the 2017-2018 cold season. The study was subsequently cancelled and enrollment was discontinued. Analysis of the 193 enrolled subjects was conducted.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

Related trials for Common Cold

Not yet recruiting
Enhanced Telemedicine in Primary Care for Acute Respiratory Tract Infections Study
Acute Respiratory Tract Infection, Ear Infection
Not yet recruitingObservational study
Post-market Clinical Follow-up Study of an Isotonic Saline Solution for the Relief of Nasal Congestion in Infants and Toddlers
Nasal Congestion, Common Cold
Recruiting
Effect of Immune X on Common Cold Incidence in Healthy Adults
Common Cold, Upper Respiratory Tract Infection (URTI)
Recruiting
Omega-Cold Supplementation With Free Fatty Acids for the Prevention of Respiratory Infections in Adults.
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Recruiting
Safety and Performance Assessment of the Decongestant Seawater Spray Pocket Valve Enriched With Essential Oils in Patients With Acute Rhinitis Associated With Nasal Obstruction: "DEVALPO"
Acute Rhinitis, Nasal Obstruction

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.

Steve Sacavage study director

Johnson and Johnson Consumer, Inc

11 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing New Formulation Phenylephrine HCl and Marketed Phenylephrine HCl in people with Common Cold, run by Johnson & Johnson Consumer Inc. (J&JCI) at 11 sites in Canada.

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 0 inclusion and 26 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: stopped early, as of the sponsor's last update on 4 Jun 2019. 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 Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Mean Change From Baseline in the Nasal Congestion Severity Score (time frame: 0-12 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03339726.

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 4 Jun 2019.