Nasal CongestionPhase 4NCT00648973
To Determine if Diphenhydramine Works for Nasal Congestion at Two Different Doses
A Phase 4 study testing Diphenhydramine 50 mg, Diphenhydramine 25 mg and Pseudoephedrine 120 mg in people with Nasal Congestion, run by Johnson & Johnson Consumer and Personal Products Worldwide at 12 sites in United States.
Trial summary
The study was to determine if the drug worked to relieve nasal congestion experienced by people with seasonal allergies. Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Nasal Congestion
- What is being tested?
- Diphenhydramine 50 mg, Diphenhydramine 25 mg and Pseudoephedrine 120 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,021 participants
- Where
- 12 sitesUnited States
- Study dates
- Nov 2006to May 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Benchmark Research - Austin
Austin, Texas, 78705
Allergy and Asthma Associates
Austin, Texas, 78731
Lovelace Scientific Resources
Austin, Texas, 78759
Allergy/Immunology Research Center of North Texas
Dallas, Texas, 75230
Kerrville Research Associates
Kerrville, Texas, 78028
Central Texas Health Research
New Braunfels, Texas, 78130
Benchmark Research - San Angelo
San Angelo, Texas, 76904
Sun Research Institute
San Antonio, Texas, 78205
Biogenics Research Institute
San Antonio, Texas, 78229
Diagnostics Research Group
San Antonio, Texas, 78229
Sylvana Research Associates
San Antonio, Texas, 78229
Allergy Asthma Research Institute
Waco, Texas, 76712
About this study
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
The study was to determine if the drug worked to relieve nasal congestion experienced by people with seasonal allergies.
Read the 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.
- Conditions
- Nasal Congestion
- Being tested
- Diphenhydramine 50 mg, Diphenhydramine 25 mg, Pseudoephedrine 120 mg
- Keywords
- Seasonal Allergic Rhinitis, nasal congestion
- Medical subject headings
- Nasal Obstruction, Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diphenhydramine 50 mgDrug
Also called Active: Lot # 070PB6 Formula # W015990-0002
Three times daily: two diphenhydramine 25 mg capsules
Twice daily: one pseudoephedrine-matching placebo tablet
Diphenhydramine 25 mgDrug
Also called Active: Lot # 070PB6 Formula # W015990-0002
Three times daily: one diphenhydramine 25 mg capsule and one diphenhydramine-matching placebo capsule
Twice daily: one pseudoephedrine-matching placebo tablet
Pseudoephedrine 120 mgDrug
Also called Active: Lot # INT-06-115 Formula # W015721-0004
Three times daily: two diphenhydramine-matching placebo capsules
Twice daily: one pseudoephedrine 120 mg tablet
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Diphenhydramine 50 mg Receives: Drug: Diphenhydramine 50 mg |
| 2 | Experimental | Diphenhydramine 25 mg Receives: Drug: Diphenhydramine 25 mg |
| 3 | Active comparator | Pseudoephedrine 120 mg Receives: Drug: Pseudoephedrine 120 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the subject's mean reflective nasal congestion/stuffiness symptom score
Measured: every 12-hours over the 14-day treatment period
Secondary outcomes (19)
Change from baseline in the subject's mean reflective Total Nasal Symptom (TNS) Score
Measured: 14 Days
Change from baseline in the subject's mean instantaneous TNS Score
Measured: 14 Days
Change from baseline in the subject's mean reflective Total SAR Symptom (TSS) Score
Measured: 14 Days
Change from baseline in the subject's mean instantaneous TSS Score
Measured: 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
Measured: 14 Days
Change from baseline in the subject's mean instantaneous score for each of the eight individual SAR symptoms
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 14 Days
Subject's global evaluation of response to treatment
Measured: at Visits 3 and 4, analyzed separately at each visit
Change from baseline in the Investigator's TNS score
Measured: 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
Measured: 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
Measured: 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
Measured: at Visits 3 and 4, analyzed separately for each visit
Number and percentage of subjects experiencing adverse events
Measured: Duration of study
Change from baseline and potentially clinically important vital signs (systolic and diastolic blood pressure, pulse, and respiratory rate)
Measured: Duration of study
Occurrence of somnolence
Measured: Overall and weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2008 (estimated)
- Study startNov 2006
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal CongestionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,021 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products Worldwide
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Melissa Israel, BS, Study director, McNeil Consumer Healthcare Division of Mc-Neil-PPC, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00648973
- Sponsor's protocol ID
- A2341002
- Status last verified
- Aug 2011
- First submitted
- 20 Mar 2008
- Last updated
- 22 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00648973
- Acronym / sponsor ID
- A2341002
- Conditions
- Nasal Congestion
- Keywords
- Seasonal Allergic Rhinitis, nasal congestion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,021 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products WorldwideIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 1 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Diphenhydramine 50 mgDiphenhydramine 50 mg |
| 2 | Experimental | Drug: Diphenhydramine 25 mgDiphenhydramine 25 mg |
| 3 | Active comparator | Drug: Pseudoephedrine 120 mgPseudoephedrine 120 mg |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diphenhydramine 50 mgAlso: Active: Lot # 070PB6 Formula # W015990-0002Three times daily: two diphenhydramine 25 mg capsules Twice daily: one pseudoephedrine-matching placebo tablet | Drug | 1 |
| Diphenhydramine 25 mgAlso: Active: Lot # 070PB6 Formula # W015990-0002Three times daily: one diphenhydramine 25 mg capsule and one diphenhydramine-matching placebo capsule Twice daily: one pseudoephedrine-matching placebo tablet | Drug | 2 |
| Pseudoephedrine 120 mgAlso: Active: Lot # INT-06-115 Formula # W015721-0004Three times daily: two diphenhydramine-matching placebo capsules Twice daily: one pseudoephedrine 120 mg tablet | Drug | 3 |
Primary outcome
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
19 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa Israel, BS study director
McNeil Consumer Healthcare Division of Mc-Neil-PPC, Inc.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Diphenhydramine 50 mg, Diphenhydramine 25 mg and Pseudoephedrine 120 mg in people with Nasal Congestion, run by Johnson & Johnson Consumer and Personal Products Worldwide at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2011.