To Determine if Diphenhydramine Works for Nasal Congestion at Two Different Doses
Information source: Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Nasal Congestion
Intervention: Diphenhydramine 50 mg (Drug); Diphenhydramine 25 mg (Drug); Pseudoephedrine 120 mg (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Johnson & Johnson Consumer and Personal Products Worldwide Official(s) and/or principal investigator(s): Melissa Israel, BS, Study Director, Affiliation: McNeil Consumer Healthcare Division of Mc-Neil-PPC, Inc.
Summary
The study was to determine if the drug worked to relieve nasal congestion experienced by
people with seasonal allergies.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Change from baseline in the subject's mean reflective nasal congestion/stuffiness symptom score
Secondary outcome: Change from baseline in the subject's mean reflective Total Nasal Symptom (TNS) ScoreChange from baseline in the subject's mean instantaneous TNS Score Change from baseline in the subject's mean reflective Total SAR Symptom (TSS) Score Change from baseline in the subject's mean instantaneous TSS Score Change from baseline in the subject's mean reflective score for each of the seven remaining individual SAR symptoms, excluding nasal congestion/stuffiness Change from baseline in the subject's mean instantaneous score for each of the eight individual SAR symptoms 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 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 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 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 Time to maximal effect was assessed by a by-day analysis of the primary efficacy endpoint and select secondary endpoints Subject's global evaluation of response to treatment Change from baseline in the Investigator's TNS score Change from baseline in the Investigator's TSS score Change from baseline for each of the eight individual Investigator's SAR symptoms Investigator's global evaluation of the subject's response to treatment Number and percentage of subjects experiencing adverse events Change from baseline and potentially clinically important vital signs (systolic and diastolic blood pressure, pulse, and respiratory rate) Occurrence of somnolence
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.
Eligibility
Minimum age: 12 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Allergy and Asthma Associates, Austin, Texas 78731, United States
Benchmark Research - Austin, Austin, Texas 78705, 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
Biogenics Research Institute, San Antonio, Texas 78229, United States
Diagnostics Research Group, San Antonio, Texas 78229, United States
Sun Research Institute, San Antonio, Texas 78205, United States
Sylvana Research Associates, San Antonio, Texas 78229, United States
Allergy Asthma Research Institute, Waco, Texas 76712, United States
Additional Information
Starting date: November 2006
Last updated: August 19, 2011
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