Clinical trial NCT00648973: To Determine if Diphenhydramine Works for Nasal Congestion at Two Different Doses
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Nasal Congestion
Keywords: Seasonal Allergic Rhinitis, nasal congestion
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2008-04-01
Enrollment: 1021
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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 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

Primary outcomes:
measure: Change from baseline in the subject's mean reflective nasal congestion/stuffiness symptom score
timeFrame: every 12-hours over the 14-day treatment period
Secondary outcomes:
measure: Change from baseline in the subject's mean reflective Total Nasal Symptom (TNS) Score
timeFrame: 14 Days
measure: Change from baseline in the subject's mean instantaneous TNS Score
timeFrame: 14 Days
measure: Change from baseline in the subject's mean reflective Total SAR Symptom (TSS) Score
timeFrame: 14 Days
measure: Change from baseline in the subject's mean instantaneous TSS Score
timeFrame: 14 Days
measure: Change from baseline in the subject's mean reflective score for each of the seven remaining individual SAR symptoms, excluding nasal congestion/stuffiness
timeFrame: 14 Days
measure: Change from baseline in the subject's mean instantaneous score for each of the eight individual SAR symptoms
timeFrame: 14 Days
measure: 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
timeFrame: taken at 15, 30, 60 and 90 minutes after the initial dose. Baseline was the score taken just prior to the initial dose.
measure: 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
timeFrame: taken at 15, 30, 60 and 90 minutes after the initial dose. Baseline was the score taken just prior to the initial dose
measure: 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
timeFrame: 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)
measure: 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
timeFrame: 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)
measure: Time to maximal effect was assessed by a by-day analysis of the primary efficacy endpoint and select secondary endpoints
timeFrame: 14 Days
measure: Subject's global evaluation of response to treatment
timeFrame: at Visits 3 and 4, analyzed separately at each visit
measure: Change from baseline in the Investigator's TNS score
timeFrame: at Visits 3 and 4, analyzed separately for each visit. Baseline was the score at Visit 1
measure: Change from baseline in the Investigator's TSS score
timeFrame: at Visits 3 and 4, analyzed separately for each visit. Baseline was the score at Visit 1
measure: Change from baseline for each of the eight individual Investigator's SAR symptoms
timeFrame: at Visits 3 and 4, analyzed separately for each visit. Baseline was the score at Visit 1
measure: Investigator's global evaluation of the subject's response to treatment
timeFrame: at Visits 3 and 4, analyzed separately for each visit
measure: Number and percentage of subjects experiencing adverse events
timeFrame: Duration of study
measure: Change from baseline and potentially clinically important vital signs (systolic and diastolic blood pressure, pulse, and respiratory rate)
timeFrame: Duration of study
measure: Occurrence of somnolence
timeFrame: Overall and weekly
Other outcomes:
Locations:
city: Austin
country: United States
facility: Benchmark Research - Austin
state: Texas
city: Austin
country: United States
facility: Allergy and Asthma Associates
state: Texas
city: Austin
country: United States
facility: Lovelace Scientific Resources
state: Texas
city: Dallas
country: United States
facility: Allergy/Immunology Research Center of North Texas
state: Texas
city: Kerrville
country: United States
facility: Kerrville Research Associates
state: Texas
city: New Braunfels
country: United States
facility: Central Texas Health Research
state: Texas
city: San Angelo
country: United States
facility: Benchmark Research - San Angelo
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute
state: Texas
city: San Antonio
country: United States
facility: Biogenics Research Institute
state: Texas
city: San Antonio
country: United States
facility: Diagnostics Research Group
state: Texas
city: San Antonio
country: United States
facility: Sylvana Research Associates
state: Texas
city: Waco
country: United States
facility: Allergy Asthma Research Institute
state: Texas
Study officials:
affiliation: McNeil Consumer Healthcare Division of Mc-Neil-PPC, Inc.
name: Melissa Israel, BS
role: STUDY_DIRECTOR
References: