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

NCT ID: NCT01413958

Last Updated: 2015-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 575 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2011-10-31

Brief Summary

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

Conditions

Seasonal Allergic Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Phenylephrine

Group Type: EXPERIMENTAL

Phenylephrine

Intervention Type: DRUG

Phenylephrine hydrochloride 30-mg extended-release tablets, one tablet every 12 hours for 7 days

Loratadine

Intervention Type: DRUG

Loratadine, 10 mg, once daily as rescue medication, only if needed for intolerable allergic rhinitis symptoms

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo to phenylephrine hydrochloride 30-mg extended release tablets, one tablet every 12 hours for 7 days

Loratadine

Intervention Type: DRUG

Loratadine, 10 mg, once daily as rescue medication, only if needed for intolerable allergic rhinitis symptoms

Interventions

Phenylephrine

Phenylephrine hydrochloride 30-mg extended-release tablets, one tablet every 12 hours for 7 days

Intervention Type: DRUG

Placebo

Placebo to phenylephrine hydrochloride 30-mg extended release tablets, one tablet every 12 hours for 7 days

Intervention Type: DRUG

Loratadine

Loratadine, 10 mg, once daily as rescue medication, only if needed for intolerable allergic rhinitis symptoms

Intervention Type: DRUG

Other Intervention Names

SCH 002063; MK-9314; Claritin®

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Meltzer EO, Ratner PH, McGraw T. Phenylephrine hydrochloride modified-release tablets for nasal congestion: a randomized, placebo-controlled trial in allergic rhinitis patients. Ann Allergy Asthma Immunol. 2016 Jan;116(1):66-71. doi: 10.1016/j.anai.2015.10.022. Epub 2015 Nov 7.

Reference Type: DERIVED

PMID: 26560899 (View on PubMed)

Other Identifiers

CL2011-06

Identifier Type: OTHER

Identifier Source: secondary_id

P08498

Identifier Type: OTHER

Identifier Source: secondary_id

18125

Identifier Type: -

Identifier Source: org_study_id