Status:
COMPLETED
To Determine if Diphenhydramine Works for Nasal Congestion at Two Different Doses
Lead Sponsor:
Johnson & Johnson Consumer and Personal Products Worldwide
Conditions:
Nasal Congestion
Eligibility:
All Genders
12-65 years
Phase:
PHASE4
Brief Summary
The study was to determine if the drug worked to relieve nasal congestion experienced by people with seasonal allergies.
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 r...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
1021 Patients enrolled
Trial Details
Trial ID
NCT00648973
Start Date
November 1 2006
End Date
May 1 2007
Last Update
August 22 2011
Active Locations (12)
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1
Benchmark Research - Austin
Austin, Texas, United States, 78705
2
Allergy and Asthma Associates
Austin, Texas, United States, 78731
3
Lovelace Scientific Resources
Austin, Texas, United States, 78759
4
Allergy/Immunology Research Center of North Texas
Dallas, Texas, United States, 75230