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

NCT03339726 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: CO-170302131230-URCT
• Study Type: interventional
• Target: 193
• Locations: 1 country
• Sites: 11

Brief 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.

Conditions

Common Cold

Outcome Measures

Primary Outcomes (1)

• 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.

  0-12 hours

Secondary Outcomes (16)

• Average Change From Baseline in the Nasal Congestion Severity Score

  0-12 hours

• Change From Baseline in the Nasal Congestion Severity Score

  0-2 hours

• Change From Baseline in the Nasal Congestion Severity Score

  0-4 hours

• Change From Baseline in the Nasal Congestion Severity Score

  0-6 hours

• Change From Baseline in the Nasal Congestion Severity Score

  0-8 hours

Study Arms (3)

New Formulation Phenylephrine HCl

EXPERIMENTAL

Drug: New Formulation Phenylephrine HCl

Marketed Phenylephrine HCl

ACTIVE COMPARATOR

Drug: Marketed Phenylephrine HCl

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

New Formulation Phenylephrine HCl DRUG

2 doses of one tablet 12 hours apart

New Formulation Phenylephrine HCl

Marketed Phenylephrine HCl DRUG

4 doses of one capsule 4 hours apart

Marketed Phenylephrine HCl

Placebo DRUG

4 doses of placebo capsule and tablet taken 4 hours apart

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Johnson & Johnson Consumer Inc. (J&JCI): lead

Study Sites (11)

The Medical Arts Health Research Group

Kelowna, British Columbia, V1Y 4N7, Canada

Location

Mission Hills Urgent Care Walk in Clinic

Mission, British Columbia, V2V 0C8, Canada

Location

James Lai, MD, Inc

Vancouver, British Columbia, Canada

Location

NEOMO Research

Greater Sudbury, Ontario, P3E 6C3, Canada

Location

Dawson Road Family Medical Clinic

Guelph, Ontario, N1H 1B1, Canada

Location

Sunningdale Health and Wellness Centre

London, Ontario, N6G 4W3, Canada

Location

Bluewater Clinical Research Group, Inc.

Sarnia, Ontario, N7T 4X3, Canada

Location

Canadian Phase Onward, Inc.

Toronto, Ontario, M3J 2C5, Canada

Location

PrimeHealth Clinical Research

Toronto, Ontario, M4S 1Y2, Canada

Location

Diex Recherche

Sherbrooke, Quebec, J1H 1Z1, Canada

Location

Diex Recherche

Victoriaville, Quebec, G6P 6P6, Canada

Location

MeSH Terms

Conditions

Common Cold

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: Steven Sacavage, PharmD, Associate Director, Global Pain & Allergy Clinical Research
• Organization: JNJWorldwide

ssacavag@its.jnj.com

215 273-8568

Study Officials

• Steve Sacavage

  Johnson and Johnson Consumer, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2017
• First Posted: November 13, 2017
• Study Start: November 30, 2017
• Primary Completion: April 16, 2018
• Study Completion: April 16, 2018
• Last Updated: June 4, 2019
• Results First Posted: June 4, 2019

Record last verified: 2019-06

Locations

CA (11)