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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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The purpose of this study was to see if high dose esomeprazole (40mg bid) was effective in treating non-allergic rhinitis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | esomeprazole 40mg po bid |
|
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| esomeprazole | Drug | 40mg by mouth twice daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Nasal Symptom Scores | (1=none, 7=unbearably severe) difference in nasal symptom scores for the average of the last two weeks of each treatment arm | Last two weeks of each treatment arm |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David A Khan, MD | Department of Allergy and Immunology, UT Southwestern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trials Office, Aston Building, UT Southwestern | Dallas | Texas | 75390-9016 | United States |
43 patients were assigned for randomization after meeting inclusion criteria: age between 18-80, symptoms of perennial rhinitis, negative epicutaneous skin testing to a panel of common aeroallergens, and ability to speak English
Patients were recruited from UT Southwestern outpatient clinics as well as through flyers and local advertising
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo First, Then Esomeprazole | Placebo twice daily for 8 weeks, then two week washout, then Esomeprazole 40mg twice daily for 8 weeks |
| FG001 | Esomeprazole First, Then Placebo | Esomeprazole 40mg twice daily for 8 weeks, then two week washout, then Placebo twice daily for 8 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
|
| |||||||||||||||||||||
| Washout Period |
| ||||||||||||||||||||||
| Second Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | 37 patients were included in Data Analysis. Study subjects were randomized to esomeprazole 40mg tablet twice daily or placebo for eight weeks each, with a two week washout crossover period in between treatment arms. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Nasal Symptom Scores | (1=none, 7=unbearably severe) difference in nasal symptom scores for the average of the last two weeks of each treatment arm | Each study participant was in both arms of the study since this was a crossover study | Posted | Mean | Full Range | score on a scale | Last two weeks of each treatment arm |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Events Occurring While Subject Was on Placebo | This arm includes all patients in the study, but focuses on the time period when they were on Placebo only. |
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Six patients did not complete the study and may have affected the outcome. Optimal duration for treatment of laryngopharyngeal reflux is unclear.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ganesh Shanmugam, MD | University of Texas Southwestern | 9797036112 | ganesh01@yahoo.com |
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| ID | Term |
|---|---|
| D012223 | Rhinitis, Vasomotor |
| D003139 | Common Cold |
| D057045 | Laryngopharyngeal Reflux |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
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| placebo | Drug |
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Baseline Reflux Score | Minimum Score = 0 Maximum Score = 14 The higher the score, the more baseline reflux symptoms | Mean | Full Range | units on a scale |
|
| Number of Patients on Intranasal Corticosteroids | Count of Participants | Participants |
|
| Number of Patients on Oral Antihistamines | Count of Participants | Participants |
|
| Number of Patients on Oral Leukotriene Receptor Antagonists | Count of Participants | Participants |
|
| Number of Patients on Intranasal Antihistamines | Count of Participants | Participants |
|
| Number of Patients on Intranasal Anticholinergics | Count of Participants | Participants |
|
| Number of Patients on Oral Decongestants | Count of Participants | Participants |
|
| Number of Patients on Intranasal Decongestants | Count of Participants | Participants |
|
| Number of Patients on Nasal Saline Rinses | Count of Participants | Participants |
|
| Number of Patients on Oral Antacids (none in two weeks prior to enrollment) | Count of Participants | Participants |
|
| Nasal Symptom Score : Sneezing | (1=None, 7=Unbelievably Severe) | Mean | Full Range | units on a scale |
|
| Nasal Symptom Score : Runny Nose | (1=None, 7=Unbelievably Severe) | Mean | Full Range | units on a scale |
|
| Nasal Symptom Score : Congestion | (1=None, 7=Unbelievably Severe) | Mean | Full Range | units on a scale |
|
| Nasal Symptom Score : Itchy Nose | (1=None, 7=Unbelievably Severe) | Mean | Full Range | units on a scale |
|
| Nasal Symptom Score : Postnasal Drip | (1=None, 7=Unbelievably Severe) | Mean | Full Range | units on a scale |
|
| Nasal Symptom Score : Total Nasal Symptoms | (1=None, 7=Unbelievably Severe) | Mean | Full Range | units on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| 0 |
| 37 |
| 0 |
| 37 |
| 0 |
| 37 |
| EG001 | Events Occurring While Subject Was on Esomeprazole | This arm includes all patients in the study, but focuses on the time period when they were on Esomeprazole only. | 0 | 37 | 0 | 37 | 0 | 37 |
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| D012141 |
| Respiratory Tract Infections |
| D007239 | Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D005764 | Gastroesophageal Reflux |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007818 | Laryngeal Diseases |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |