To Determine if Diphenhydramine Works for Nasal Congestion at Two Different Doses

Nasal Congestion Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00648973
• Other study ID #: A2341002
• Status: Completed
• Phase: Phase 4
• First received: March 20, 2008
• Last updated: August 19, 2011
• Start date: November 2006
• Est. completion date: May 2007

Study information

• Verified date: August 2011
• Source: Johnson & Johnson Consumer and Personal Products Worldwide
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The study was to determine if the drug worked to relieve nasal congestion experienced by people with seasonal allergies.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1021
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nasal Congestion
• Rhinitis, Allergic, Seasonal

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Allergy and Asthma Associates	Austin	Texas
United States	Benchmark Research - Austin	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	Biogenics Research Institute	San Antonio	Texas
United States	Diagnostics Research Group	San Antonio	Texas
United States	Sun Research Institute	San Antonio	Texas
United States	Sylvana Research Associates	San Antonio	Texas
United States	Allergy Asthma Research Institute	Waco	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Consumer and Personal Products Worldwide

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the subject's mean reflective nasal congestion/stuffiness symptom score		every 12-hours over the 14-day treatment period	No
Secondary	Change from baseline in the subject's mean reflective Total Nasal Symptom (TNS) Score		14 Days	No
Secondary	Change from baseline in the subject's mean instantaneous TNS Score		14 Days	No
Secondary	Change from baseline in the subject's mean reflective Total SAR Symptom (TSS) Score		14 Days	No
Secondary	Change from baseline in the subject's mean instantaneous TSS Score		14 Days	No
Secondary	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	No
Secondary	Change from baseline in the subject's mean instantaneous score for each of the eight individual SAR symptoms		14 Days	No
Secondary	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		taken at 15, 30, 60 and 90 minutes after the initial dose. Baseline was the score taken just prior to the initial dose.	No
Secondary	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		taken at 15, 30, 60 and 90 minutes after the initial dose. Baseline was the score taken just prior to the initial dose	No
Secondary	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		taken at the six-hour trough (just prior to the 8:00 pm dose) and the 12-hour trough (just prior to the 8:00 am dose)	No
Secondary	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		taken at the six-hour trough (just prior to the 8:00 pm dose) and the 12-hour trough (just prior to the 8:00 am dose)	No
Secondary	Time to maximal effect was assessed by a by-day analysis of the primary efficacy endpoint and select secondary endpoints		14 Days	No
Secondary	Subject's global evaluation of response to treatment		at Visits 3 and 4, analyzed separately at each visit	No
Secondary	Change from baseline in the Investigator's TNS score		at Visits 3 and 4, analyzed separately for each visit. Baseline was the score at Visit 1	No
Secondary	Change from baseline in the Investigator's TSS score		at Visits 3 and 4, analyzed separately for each visit. Baseline was the score at Visit 1	No
Secondary	Change from baseline for each of the eight individual Investigator's SAR symptoms		at Visits 3 and 4, analyzed separately for each visit. Baseline was the score at Visit 1	No
Secondary	Investigator's global evaluation of the subject's response to treatment		at Visits 3 and 4, analyzed separately for each visit	No
Secondary	Number and percentage of subjects experiencing adverse events		Duration of study	No
Secondary	Change from baseline and potentially clinically important vital signs (systolic and diastolic blood pressure, pulse, and respiratory rate)		Duration of study	No
Secondary	Occurrence of somnolence		Overall and weekly	No