To Determine if Diphenhydramine Works for Nasal Congestion at Two Different Doses

Evaluation of Nasal Congestion Clinical Efficacy for Diphenhydramine 25 mg and Diphenhydramine 50 mg in Seasonal Allergic Rhinitis: a Randomized, Double-blind, Placebo and Pseudoephedrine Controlled Study

The study was to determine if the drug worked to relieve nasal congestion experienced by people with seasonal allergies.

Study Overview

• Status: Completed
• Conditions: Nasal Congestion
• Intervention / Treatment: Drug: Diphenhydramine 50 mg; Drug: Diphenhydramine 25 mg; Drug: Pseudoephedrine 120 mg

Detailed Description

Subjects who met the inclusion/exclusion criteria were enrolled into the placebo run-in phase of the study on Day -7 (prerandomization, Visit 1). Baseline symptom scores were established during this run-in phase.

Subjects with moderate nasal congestion who took at least 80% of their study medication during the run-in phase were eligible for enrollment in the two-week double-blind phase of the study and were randomized on Day 1 (randomization, Visit 2). They were treated for two weeks with their assigned medication. The severity of signs/symptoms were evaluated by the subjects every morning and night and by the investigator at each visit on Day 7 and Day 14.

In addition, the subject and investigator provided a global evaluation of response to treatment on Day 7 and Day 14. Safety was evaluated by adverse events reported during the study, vital signs, and the incidence of somnolence.

• Study Type: Interventional
• Enrollment (Actual): 1021
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78731
      • Allergy and Asthma Associates
    • Austin, Texas, United States, 78759
      • Lovelace Scientific Resources
    • Austin, Texas, United States, 78705
      • Benchmark Research - Austin
    • Dallas, Texas, United States, 75230
      • Allergy/Immunology Research Center of North Texas
    • Kerrville, Texas, United States, 78028
      • Kerrville Research Associates
    • New Braunfels, Texas, United States, 78130
      • Central Texas Health Research
    • San Angelo, Texas, United States, 76904
      • Benchmark Research - San Angelo
    • San Antonio, Texas, United States, 78229
      • Diagnostics Research Group
    • San Antonio, Texas, United States, 78229
      • Biogenics Research Institute
    • San Antonio, Texas, United States, 78229
      • Sylvana Research Associates
    • San Antonio, Texas, United States, 78205
      • Sun Research Institute
    • Waco, Texas, United States, 76712
      • Allergy Asthma Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 61 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• otherwise healthy males and females
• 12 to 65 years of age
• hypersensitivity to specific pollens for a minimum of 2 years prior to study start
• appropriate SAR sign/symptoms scores

Exclusion Criteria:

• pregnancy, lactation and contraception issues
• contraindicated medications or therapies
• evidence of clinical, dietary, lifestyle or psychiatric issues, which in the opinion of the investigator, could increase the risk to the subject or research staff, or interfere with the interpretation of study results

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Diphenhydramine 50 mg	Drug: Diphenhydramine 50 mg; Three times daily: two diphenhydramine 25 mg capsules Twice daily: one pseudoephedrine-matching placebo tablet; Other Names: Active: Lot # 070PB6 Formula # W015990-0002
Experimental: 2; Diphenhydramine 25 mg	Drug: Diphenhydramine 25 mg; Three times daily: one diphenhydramine 25 mg capsule and one diphenhydramine-matching placebo capsule Twice daily: one pseudoephedrine-matching placebo tablet; Other Names: Active: Lot # 070PB6 Formula # W015990-0002
Active Comparator: 3; Pseudoephedrine 120 mg	Drug: Pseudoephedrine 120 mg; Three times daily: two diphenhydramine-matching placebo capsules Twice daily: one pseudoephedrine 120 mg tablet; Other Names: Active: Lot # INT-06-115 Formula # W015721-0004

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in the subject's mean reflective nasal congestion/stuffiness symptom score	every 12-hours over the 14-day treatment period

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in the subject's mean reflective Total Nasal Symptom (TNS) Score	14 Days
Change from baseline in the subject's mean instantaneous TNS Score	14 Days
Change from baseline in the subject's mean reflective Total SAR Symptom (TSS) Score	14 Days
Change from baseline in the subject's mean instantaneous TSS Score	14 Days
Change from baseline in the subject's mean reflective score for each of the seven remaining individual SAR symptoms, excluding nasal congestion/stuffiness	14 Days
Change from baseline in the subject's mean instantaneous score for each of the eight individual SAR symptoms	14 Days
Onset of action for diphenhydramine treatment for nasal congestion/stuffiness was determined by comparing the change from baseline in the subject's instantaneous nasal congestion/stuffiness scores for diphenhydramine versus placebo	taken at 15, 30, 60 and 90 minutes after the initial dose. Baseline was the score taken just prior to the initial dose.
Onset of action for diphenhydramine treatment for allergic rhinitis symptoms was determined by comparing the change from baseline in the subject's instantaneous TNS scores for diphenhydramine versus placebo	taken at 15, 30, 60 and 90 minutes after the initial dose. Baseline was the score taken just prior to the initial dose
Duration of action for diphenhydramine for treatment of nasal congestion/stuffiness was evaluated by comparing the change from baseline in the subject's mean instantaneous nasal congestion/stuffiness scores for diphenhydramine versus placebo	taken at the six-hour trough (just prior to the 8:00 pm dose) and the 12-hour trough (just prior to the 8:00 am dose)
Duration of action for diphenhydramine for treatment of allergic rhinitis symptoms was evaluated by comparing the change from baseline in the subject's mean instantaneous TNS scores for diphenhydramine versus placebo	taken at the six-hour trough (just prior to the 8:00 pm dose) and the 12-hour trough (just prior to the 8:00 am dose)
Time to maximal effect was assessed by a by-day analysis of the primary efficacy endpoint and select secondary endpoints	14 Days
Subject's global evaluation of response to treatment	at Visits 3 and 4, analyzed separately at each visit
Change from baseline in the Investigator's TNS score	at Visits 3 and 4, analyzed separately for each visit. Baseline was the score at Visit 1
Change from baseline in the Investigator's TSS score	at Visits 3 and 4, analyzed separately for each visit. Baseline was the score at Visit 1
Change from baseline for each of the eight individual Investigator's SAR symptoms	at Visits 3 and 4, analyzed separately for each visit. Baseline was the score at Visit 1
Investigator's global evaluation of the subject's response to treatment	at Visits 3 and 4, analyzed separately for each visit
Number and percentage of subjects experiencing adverse events	Duration of study
Change from baseline and potentially clinically important vital signs (systolic and diastolic blood pressure, pulse, and respiratory rate)	Duration of study
Occurrence of somnolence	Overall and weekly

Collaborators and Investigators

• Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
• Investigators: Study Director: Melissa Israel, BS, McNeil Consumer Healthcare Division of Mc-Neil-PPC, Inc.

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Primary Completion (Actual): May 1, 2007
• Study Completion (Actual): May 1, 2007

Study Registration Dates

• First Submitted: March 20, 2008
• First Submitted That Met QC Criteria: March 27, 2008
• First Posted (Estimate): April 1, 2008

Study Record Updates

• Last Update Posted (Estimate): August 22, 2011
• Last Update Submitted That Met QC Criteria: August 19, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: Seasonal Allergic Rhinitis, nasal congestion
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis, Allergic; Rhinitis; Rhinitis, Allergic, Seasonal; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Antiemetics; Gastrointestinal Agents; Dermatologic Agents; Hypnotics and Sedatives; Anesthetics, Local; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Sleep Aids, Pharmaceutical; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Antipruritics; Central Nervous System Stimulants; Sympathomimetics; Vasoconstrictor Agents; Nasal Decongestants; Diphenhydramine; Promethazine; Ephedrine; Pseudoephedrine
• Other Study ID Numbers: A2341002