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

Johnson & Johnson (J&J)

Status and phase: Completed; Phase 4

Conditions: Nasal Congestion

Treatments: Drug: Diphenhydramine 25 mg; Drug: Diphenhydramine 50 mg; Drug: Pseudoephedrine 120 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00648973

A2341002

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,021 patients

Sex: All

Ages: 12 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,021 participants in 3 patient groups

1

Experimental group

Description:

Diphenhydramine 50 mg

Treatment:

Drug: Diphenhydramine 50 mg

2

Experimental group

Description:

Diphenhydramine 25 mg

Treatment:

Drug: Diphenhydramine 25 mg

3

Active Comparator group

Description:

Pseudoephedrine 120 mg

Treatment:

Drug: Pseudoephedrine 120 mg