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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00648973
Recruitment Status : Completed
First Posted : April 1, 2008
Last Update Posted : August 22, 2011
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide

Tracking Information
First Submitted Date  ICMJE March 20, 2008
First Posted Date  ICMJE April 1, 2008
Last Update Posted Date August 22, 2011
Study Start Date  ICMJE November 2006
Actual Primary Completion Date May 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE To Determine if Diphenhydramine Works for Nasal Congestion at Two Different Doses
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Nasal Congestion
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 27, 2008)
1021
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2007
Actual Primary Completion Date May 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00648973
Other Study ID Numbers  ICMJE A2341002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Johnson & Johnson Consumer and Personal Products Worldwide
Original Responsible Party Joyce Hauze/Clinical Documentation Administrator, JJCPPW
Current Study Sponsor  ICMJE Johnson & Johnson Consumer and Personal Products Worldwide
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP