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Completed

NCT Number: NCT00648973

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

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

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Key information

Conditions

Nasal Congestion Airway Obstruction Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nasal Obstruction Nose Diseases Otorhinolaryngologic Diseases Respiration Disorders Respiratory Hypersensitivity Respiratory Insufficiency Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal

Age range

12 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Allergy and Asthma Associates, Austin, Texas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diphenhydramine 50 mg

Drug

Three times daily: two diphenhydramine 25 mg capsules

Twice daily: one pseudoephedrine-matching placebo tablet

Other names: Active: Lot # 070PB6 Formula # W015990-0002

Diphenhydramine 25 mg

Drug

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

Twice daily: one pseudoephedrine-matching placebo tablet

Other names: Active: Lot # 070PB6 Formula # W015990-0002

Pseudoephedrine 120 mg

Drug

Three times daily: two diphenhydramine-matching placebo capsules

Twice daily: one pseudoephedrine 120 mg tablet

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Change from baseline in the subject's mean reflective Total Nasal Symptom (TNS) Score

    Time frame: 14 Days

  2. Change from baseline in the subject's mean instantaneous TNS Score

    Time frame: 14 Days

  3. Change from baseline in the subject's mean reflective Total SAR Symptom (TSS) Score

    Time frame: 14 Days

  4. Change from baseline in the subject's mean instantaneous TSS Score

    Time frame: 14 Days

  5. 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

  6. Change from baseline in the subject's mean instantaneous score for each of the eight individual SAR symptoms

    Time frame: 14 Days

  7. 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.

  8. 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

  9. 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)

  10. 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)

  11. Time to maximal effect was assessed by a by-day analysis of the primary efficacy endpoint and select secondary endpoints

    Time frame: 14 Days

  12. Subject's global evaluation of response to treatment

    Time frame: at Visits 3 and 4, analyzed separately at each visit

  13. 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

  14. 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

  15. 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

  16. Investigator's global evaluation of the subject's response to treatment

    Time frame: at Visits 3 and 4, analyzed separately for each visit

  17. Number and percentage of subjects experiencing adverse events

    Time frame: Duration of study

  18. Change from baseline and potentially clinically important vital signs (systolic and diastolic blood pressure, pulse, and respiratory rate)

    Time frame: Duration of study

  19. Occurrence of somnolence

    Time frame: Overall and weekly

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Consumer and Personal Products Worldwide

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Apr 1, 2008
Registry last updated
Aug 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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