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
1 other identifier
interventional
1,021
1 country
12
Brief Summary
The study was to determine if the drug worked to relieve nasal congestion experienced by people with seasonal allergies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2006
Shorter than P25 for phase_4
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 20, 2008
CompletedFirst Posted
Study publicly available on registry
April 1, 2008
CompletedAugust 22, 2011
August 1, 2011
6 months
March 20, 2008
August 19, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in the subject's mean reflective nasal congestion/stuffiness symptom score
every 12-hours over the 14-day treatment period
Secondary Outcomes (19)
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
- +14 more secondary outcomes
Study Arms (3)
1
EXPERIMENTALDiphenhydramine 50 mg
2
EXPERIMENTALDiphenhydramine 25 mg
3
ACTIVE COMPARATORPseudoephedrine 120 mg
Interventions
Three times daily: two diphenhydramine 25 mg capsules Twice daily: one pseudoephedrine-matching placebo tablet
Three times daily: one diphenhydramine 25 mg capsule and one diphenhydramine-matching placebo capsule Twice daily: one pseudoephedrine-matching placebo tablet
Three times daily: two diphenhydramine-matching placebo capsules Twice daily: one pseudoephedrine 120 mg tablet
Eligibility Criteria
You may qualify if:
- otherwise healthy males and females
- to 65 years of age
- hypersensitivity to specific pollens for a minimum of 2 years prior to study start
- appropriate SAR sign/symptoms scores
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Benchmark Research - Austin
Austin, Texas, 78705, United States
Allergy and Asthma Associates
Austin, Texas, 78731, United States
Lovelace Scientific Resources
Austin, Texas, 78759, United States
Allergy/Immunology Research Center of North Texas
Dallas, Texas, 75230, United States
Kerrville Research Associates
Kerrville, Texas, 78028, United States
Central Texas Health Research
New Braunfels, Texas, 78130, United States
Benchmark Research - San Angelo
San Angelo, Texas, 76904, United States
Sun Research Institute
San Antonio, Texas, 78205, United States
Biogenics Research Institute
San Antonio, Texas, 78229, United States
Diagnostics Research Group
San Antonio, Texas, 78229, United States
Sylvana Research Associates
San Antonio, Texas, 78229, United States
Allergy Asthma Research Institute
Waco, Texas, 76712, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Melissa Israel, BS
McNeil Consumer Healthcare Division of Mc-Neil-PPC, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2008
First Posted
April 1, 2008
Study Start
November 1, 2006
Primary Completion
May 1, 2007
Study Completion
May 1, 2007
Last Updated
August 22, 2011
Record last verified: 2011-08