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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) Score

Change 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

Page last updated: August 23, 2015

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