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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier:
NCT00648973
First received: March 20, 2008
Last updated: August 19, 2011
Last verified: August 2011
  Purpose

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


Condition Intervention Phase
Nasal Congestion
Drug: Diphenhydramine 50 mg
Drug: Diphenhydramine 25 mg
Drug: Pseudoephedrine 120 mg
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Consumer and Personal Products Worldwide:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in the subject's mean reflective Total Nasal Symptom (TNS) Score [ Time Frame: 14 Days ] [ Designated as safety issue: No ]
  • Change from baseline in the subject's mean instantaneous TNS Score [ Time Frame: 14 Days ] [ Designated as safety issue: No ]
  • Change from baseline in the subject's mean reflective Total SAR Symptom (TSS) Score [ Time Frame: 14 Days ] [ Designated as safety issue: No ]
  • Change from baseline in the subject's mean instantaneous TSS Score [ Time Frame: 14 Days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change from baseline in the subject's mean instantaneous score for each of the eight individual SAR symptoms [ Time Frame: 14 Days ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Time to maximal effect was assessed by a by-day analysis of the primary efficacy endpoint and select secondary endpoints [ Time Frame: 14 Days ] [ Designated as safety issue: No ]
  • Subject's global evaluation of response to treatment [ Time Frame: at Visits 3 and 4, analyzed separately at each visit ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Investigator's global evaluation of the subject's response to treatment [ Time Frame: at Visits 3 and 4, analyzed separately for each visit ] [ Designated as safety issue: No ]
  • Number and percentage of subjects experiencing adverse events [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
  • Change from baseline and potentially clinically important vital signs (systolic and diastolic blood pressure, pulse, and respiratory rate) [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
  • Occurrence of somnolence [ Time Frame: Overall and weekly ] [ Designated as safety issue: No ]

Enrollment: 1021
Study Start Date: November 2006
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Diphenhydramine 50 mg
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
Experimental: 2
Diphenhydramine 25 mg
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
Active Comparator: 3
Pseudoephedrine 120 mg
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

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

Ages Eligible for Study:   12 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00648973

Locations
United States, Texas
Lovelace Scientific Resources
Austin, Texas, United States, 78759
Allergy and Asthma Associates
Austin, Texas, United States, 78731
Benchmark Research - Austin
Austin, Texas, United States, 78705
Allergy/Immunology Research Center of North Texas
Dallas, Texas, United States, 75230
Kerrville Research Associates
Kerrville, Texas, United States, 78028
Central Texas Health Research
New Braunfels, Texas, United States, 78130
Benchmark Research - San Angelo
San Angelo, Texas, United States, 76904
Sun Research Institute
San Antonio, Texas, United States, 78205
Sylvana Research Associates
San Antonio, Texas, United States, 78229
Diagnostics Research Group
San Antonio, Texas, United States, 78229
Biogenics Research Institute
San Antonio, Texas, United States, 78229
Allergy Asthma Research Institute
Waco, Texas, United States, 76712
Sponsors and Collaborators
Johnson & Johnson Consumer and Personal Products Worldwide
Investigators
Study Director: Melissa Israel, BS McNeil Consumer Healthcare Division of Mc-Neil-PPC, Inc.
  More Information

No publications provided

Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier: NCT00648973     History of Changes
Other Study ID Numbers: A2341002
Study First Received: March 20, 2008
Last Updated: August 19, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide:
Seasonal Allergic Rhinitis, nasal congestion

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Diphenhydramine
Promethazine
Pseudoephedrine
Ephedrine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Allergic Agents
Anesthetics, Local

ClinicalTrials.gov processed this record on April 14, 2014