Effects of Phenylephrine Extended-Release Tablets on Allergy-Related Nasal Congestion (P08498 AM1)

Bayer

Status and phase

Completed

Phase 3

Conditions

Seasonal Allergic Rhinitis

Treatments

Drug: Placebo

Drug: Loratadine

Drug: Phenylephrine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01413958

P08498 (Other Identifier)

CL2011-06 (Other Identifier)

18125

Details and patient eligibility

About

This study will compare the nasal congestion symptom relief of phenylephrine extended release tablets and placebo in participants with allergic rhinitis.

Enrollment

575 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Understands study procedures and agrees to participate by giving signed consent form
Male or female, aged 18 years or older, at the Screening Visit.
Female participants must demonstrate a negative urine pregnancy test, at Screening (Visit 1) and Visit 2 (prior to randomization) and agree to use (and/or have their partner use) 2 acceptable methods of birth control beginning at the Screening visit and throughout the study and until 2 weeks after the last dose of study drug in the last treatment period. Acceptable methods of birth control are abstinence, or two of the following:
- hormonal contraceptives (with documented use for at least 30 days prior to Screening )
- intrauterine device (IUD)
- diaphragm with spermicide
- contraceptive sponge
- condom
- vasectomy
Willing to stop use of current decongestant and allergy medications during the trial
Documented or self-reported history of allergic rhinitis caused by fall pollen within the last 4 years

and documented or self-reported symptoms over at least the last 2 fall allergy seasons

Documented skin testing (prick with wheal ≥3 mm larger than the diluent or intradermal with wheal ≥7 mm larger than the diluent control) within the last 4 years to fall pollen allergens present and prevalent in his/her geographic region.
Signs and symptoms of nasal congestion (defined as stuffy or blocked nose) of at least mild severity (sign/symptom clearly present, but minimal awareness; easily tolerated) following the washout period (if applicable). Participant's diary evaluation must document at least mild symptoms for reflective and instantaneous scores on 4 consecutive days prior to randomization.
Mean seated (after 5 minutes of rest) systolic/diastolic blood pressure ≤ 138/88 mmHg.
Clinically acceptable physical exam and 12-lead ECG (recorded at 25 mm/s) that is clinically acceptable to the investigator.
Free of any clinically significant disease that requires a physician's care and/or would interfere with trial evaluations, procedures, or participation.
Agrees not to take monoamine oxidase inhibitors (MAOIs) from 14 days before trial participation until 14 days after the last dose of study drug.
Capable of reading English.

Exclusion criteria

Significant medical condition that is a contraindication to the use of phenylephrine, might

interfere with the trial, or requires treatment expected to affect blood pressure

History or presence of hypertension
Started allergen immunotherapy within 1 month of enrollment, will start immunotherapy during

the trial, or anticipates immunotherapy dose change during the trial

Used Xolair (omalizumab) within 4 years prior to trial participation
Known allergy or intolerance to phenylephrine, loratadine, or desloratadine
History of rhinitis medicamentosa
Documented evidence of acute or significant chronic sinusitis
Clinically significant nasal disorders such as deviated septum and nasal polyposis
Asthma, with the exception of mild intermittent asthma
Have used systemic (oral, rectal, injectable), topical (up to 1% topical hydrocortisone

permitted), or nasal corticosteroids in the last 30 days

Mentally or legally incapacitated, has significant emotional problems at the time of the Screening Visit or expected during the conduct of the study, or has a history of a clinically significant psychiatric disorder over the last 5 years. Those who have had situational depression may be enrolled in the study at the discretion of the investigator.
History of any illness that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the participant by their participation in the study.
History of immunological disease or cancer within the past 5 years, with the exception of nonmelanoma skin cancer
Positive drug screen (participants on prescribed medication resulting in a positive drug screen result may still be enrolled at the discretion of the investigator).
Major surgery or participation in another investigational study within 30 days prior to the Screening Visit.
Body mass index (BMI) ≥ 40