To Determine if Diphenhydramine Works for Nasal Congestion at Two Different Doses
NCT ID: NCT00648973
Last Updated: 2011-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
1021 participants
INTERVENTIONAL
2006-11-30
2007-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Diphenhydramine 50 mg
Diphenhydramine 50 mg
Three times daily: two diphenhydramine 25 mg capsules
Twice daily: one pseudoephedrine-matching placebo tablet
2
Diphenhydramine 25 mg
Diphenhydramine 25 mg
Three times daily: one diphenhydramine 25 mg capsule and one diphenhydramine-matching placebo capsule
Twice daily: one pseudoephedrine-matching placebo tablet
3
Pseudoephedrine 120 mg
Pseudoephedrine 120 mg
Three times daily: two diphenhydramine-matching placebo capsules
Twice daily: one pseudoephedrine 120 mg tablet
Interventions
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Diphenhydramine 50 mg
Three times daily: two diphenhydramine 25 mg capsules
Twice daily: one pseudoephedrine-matching placebo tablet
Diphenhydramine 25 mg
Three times daily: one diphenhydramine 25 mg capsule and one diphenhydramine-matching placebo capsule
Twice daily: one pseudoephedrine-matching placebo tablet
Pseudoephedrine 120 mg
Three times daily: two diphenhydramine-matching placebo capsules
Twice daily: one pseudoephedrine 120 mg tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Years
65 Years
ALL
No
Sponsors
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Johnson & Johnson Consumer and Personal Products Worldwide
INDUSTRY
Responsible Party
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Principal Investigators
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Melissa Israel, BS
Role: STUDY_DIRECTOR
McNeil Consumer Healthcare Division of Mc-Neil-PPC, Inc.
Locations
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Benchmark Research - Austin
Austin, Texas, United States
Allergy and Asthma Associates
Austin, Texas, United States
Lovelace Scientific Resources
Austin, Texas, United States
Allergy/Immunology Research Center of North Texas
Dallas, Texas, United States
Kerrville Research Associates
Kerrville, Texas, United States
Central Texas Health Research
New Braunfels, Texas, United States
Benchmark Research - San Angelo
San Angelo, Texas, United States
Sun Research Institute
San Antonio, Texas, United States
Biogenics Research Institute
San Antonio, Texas, United States
Diagnostics Research Group
San Antonio, Texas, United States
Sylvana Research Associates
San Antonio, Texas, United States
Allergy Asthma Research Institute
Waco, Texas, United States
Countries
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Other Identifiers
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A2341002
Identifier Type: -
Identifier Source: org_study_id
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