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

• ClinicalTrials.gov Identifier: NCT00648973
• Recruitment Status: Completed
• First Posted: April 1, 2008
• Last Update Posted: August 22, 2011
• Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
• Information provided by (Responsible Party): Johnson & Johnson Consumer and Personal Products Worldwide

Tracking Information

• First Submitted Date: March 20, 2008
• First Posted Date: April 1, 2008
• Last Update Posted Date: August 22, 2011
• Study Start Date: November 2006
• Actual Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 27, 2008): Change from baseline in the subject's mean reflective nasal congestion/stuffiness symptom score [ Time Frame: every 12-hours over the 14-day treatment period ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 27, 2008)

• Change from baseline in the subject's mean reflective Total Nasal Symptom (TNS) Score [ Time Frame: 14 Days ]
• Change from baseline in the subject's mean instantaneous TNS Score [ Time Frame: 14 Days ]
• Change from baseline in the subject's mean reflective Total SAR Symptom (TSS) Score [ Time Frame: 14 Days ]
• Change from baseline in the subject's mean instantaneous TSS Score [ Time Frame: 14 Days ]
• Change from baseline in the subject's mean reflective score for each of the seven remaining individual SAR symptoms, excluding nasal congestion/stuffiness [ Time Frame: 14 Days ]
• Change from baseline in the subject's mean instantaneous score for each of the eight individual SAR symptoms [ Time Frame: 14 Days ]
• 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 [ Time Frame: taken at 15, 30, 60 and 90 minutes after the initial dose. Baseline was the score taken just prior to the initial dose. ]
• 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 [ Time Frame: taken at 15, 30, 60 and 90 minutes after the initial dose. Baseline was the score taken just prior to the initial dose ]
• 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 [ Time Frame: 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) ]
• 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 Frame: 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) ]
• Time to maximal effect was assessed by a by-day analysis of the primary efficacy endpoint and select secondary endpoints [ Time Frame: 14 Days ]
• Subject's global evaluation of response to treatment [ Time Frame: at Visits 3 and 4, analyzed separately at each visit ]
• Change from baseline in the Investigator's TNS score [ Time Frame: at Visits 3 and 4, analyzed separately for each visit. Baseline was the score at Visit 1 ]
• Change from baseline in the Investigator's TSS score [ Time Frame: at Visits 3 and 4, analyzed separately for each visit. Baseline was the score at Visit 1 ]
• Change from baseline for each of the eight individual Investigator's SAR symptoms [ Time Frame: at Visits 3 and 4, analyzed separately for each visit. Baseline was the score at Visit 1 ]
• Investigator's global evaluation of the subject's response to treatment [ Time Frame: at Visits 3 and 4, analyzed separately for each visit ]
• Number and percentage of subjects experiencing adverse events [ Time Frame: Duration of study ]
• Change from baseline and potentially clinically important vital signs (systolic and diastolic blood pressure, pulse, and respiratory rate) [ Time Frame: Duration of study ]
• Occurrence of somnolence [ Time Frame: Overall and weekly ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.

• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Nasal Congestion

Intervention

• Drug: Diphenhydramine 50 mg

  Three times daily: two diphenhydramine 25 mg capsules

  Twice daily: one pseudoephedrine-matching placebo tablet

  Other Name: Active: Lot # 070PB6 Formula # W015990-0002
• Drug: Diphenhydramine 25 mg

  Three times daily: one diphenhydramine 25 mg capsule and one diphenhydramine-matching placebo capsule

  Twice daily: one pseudoephedrine-matching placebo tablet

  Other Name: Active: Lot # 070PB6 Formula # W015990-0002
• Drug: Pseudoephedrine 120 mg

  Three times daily: two diphenhydramine-matching placebo capsules

  Twice daily: one pseudoephedrine 120 mg tablet

  Other Name: Active: Lot # INT-06-115 Formula # W015721-0004

Study Arms

• Experimental: 1
  Diphenhydramine 50 mg
  Intervention: Drug: Diphenhydramine 50 mg
• Experimental: 2
  Diphenhydramine 25 mg
  Intervention: Drug: Diphenhydramine 25 mg
• Active Comparator: 3
  Pseudoephedrine 120 mg
  Intervention: Drug: Pseudoephedrine 120 mg

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 27, 2008): 1021
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: May 2007
• Actual Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 12 Years to 65 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00648973
• Other Study ID Numbers: A2341002
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide
• Original Responsible Party: Joyce Hauze/Clinical Documentation Administrator, JJCPPW
• Current Study Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Melissa Israel, BS; McNeil Consumer Healthcare Division of Mc-Neil-PPC, Inc.

• PRS Account: Johnson & Johnson Consumer and Personal Products Worldwide
• Verification Date: August 2011