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

NCT01413958 | Completed Phase 3 Results

• 3 other identifiers: 18125CL2011-06P08498
• Study Type: interventional
• Target: 575
• Locations: 0 countries
• Sites: N/A

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

Keywords

Nasal Decongestants; Rhinitis, Allergic, Seasonal; Rhinitis; Nose Conditions; Respiratory Tract Diseases; Phenylephrine

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in Daily Reflective Nasal Congestion Score

  The reflective assessment is a self-evaluation of the symptom severity over the preceding 12 hours. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The nasal congestion score was calculated from data captured twice daily (morning and evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), and 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping). The average of individual reflective nasal scores was reported as the daily reflective nasal congestion score over the entire treatment period.

  Baseline and Days 1-7

Secondary Outcomes (13)

• Mean Change From Baseline in the Morning Reflective Symptom Assessment Score

  Baseline and Days 1-7

• Mean Change From Baseline in the Evening Reflective Symptom Assessment Score

  Baseline and Days 1-7

• Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score

  Baseline and Days 1-7

• Mean Change From Baseline in Daily Reflective Nasal Congestion Score Per Day

  Baseline and Day 1, 2, 3, 4, 5, 6, and 7

• Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score Per Day

  Baseline and Day 1, 2, 3, 4, 5, 6, 7

Study Arms (2)

Phenylephrine

EXPERIMENTAL

Drug: Phenylephrine; Drug: Loratadine

Placebo

PLACEBO COMPARATOR

Drug: Placebo; Drug: Loratadine

Interventions

Phenylephrine DRUG

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

Also known as: SCH 002063, MK-9314

Phenylephrine

Placebo DRUG

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

Placebo

Loratadine DRUG

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

Also known as: Claritin®

Phenylephrine; Placebo

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Bayer: lead

Related Publications (1)

• 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.

  PMID: 26560899 DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal; Rhinitis; Respiratory Tract Diseases

Interventions

Phenylephrine; Loratadine

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Nose Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiratory Tract Infections; Infections

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Cyproheptadine; Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2011
• First Posted: August 10, 2011
• Study Start: August 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: March 11, 2015
• Results First Posted: January 29, 2013

Record last verified: 2015-02