An interventional study of esomeprazole and placebo in Vasomotor Rhinitis, sponsored by University of Texas Southwestern Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-06-11.
Sponsored by University of Texas Southwestern Medical Center · Not applicable, Interventional, and Treatment
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Among 47 studies in Common Cold with a site in United States — 7 open to participants now, 8 under way, none of them phase 3. Common Cold · United States.
Among the 47 studies in Common Cold with a site in United States, this one is the 33rd largest by enrollment of the 40 interventional ones that give a count, is one of 2 that started in 2005, is one of 20 with no phase, and was the 12th registered.
219 studies on the registry are indexed under Common Cold; 23 are open to participants now.
Browse Common Cold studies →7 of the 47 studies in Common Cold with a site in United States are open now. Recruiting first, the newest first:
Colorado State University · Sites in United States
Ages 18–40 · Healthy volunteers
Quantec Ltd · Sites in United States
Ages 60+ · Healthy volunteers
Center For Interventional Pain and Spine · Sites in United States
Ages 18+ · Healthy volunteers
Indiana University · Sites in United States
Ages 18–40 · Healthy volunteers
Children's National Research Institute · Sites in United States
Ages 6–17
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 14 Common Cold studies recruiting now, 4 (29%) set no upper age limit and 9 (64%) stop at 75 or younger; 4 take children under 18; 7 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
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47 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 2 started in 2005.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 43 is below the median of 150 across 184 interventional studies indexed under Common Cold.
Median enrollment 228 across the 40 interventional studies, 121 across the 6 observational. Of the 37 that completed or were terminated, 14 (38%) have results posted.
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17 of 47 have an industry lead sponsor. The 10 most frequent:
University of Texas Southwestern Medical Center is the lead sponsor of 1,012 studies on the registry; 201 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 105 (76%) have results posted.
University of Texas Southwestern Medical Center has 1 study filed under Common Cold — fewer than ten, so there is no comparison to draw.
3 of the studies in Common Cold with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05822141Indiana UniversityOmega-3 Fatty Acids as Regulators of Brown Adipose Tissue During Cold Exposure | 2026-12 |
| NCT07297823Colorado State UniversitySex Differences in Cold-Induced Changes in Maximal Fat Oxidation | 2026-12-31 |
| NCT07706595University of California, San DiegoA Randomized Controlled Trial Comparing Posterior Nasal Nerve Ablation Procedures for Chronic Rhinitis | 2027-08-01 |
Add all 3 to your calendar (.ics) → With an account.
Among the 47 studies in Common Cold with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this study was to see if high dose esomeprazole (40mg bid) was effective in treating non-allergic rhinitis
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
esomeprazole 40mg po bid
Drug: esomeprazole
Drug: placebo
40mg by mouth twice daily
Also known as: Nexium
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
Time frame: Last two weeks of each treatment arm
Patients were recruited from UT Southwestern outpatient clinics as well as through flyers and local advertising
| Milestone | Placebo First, Then Esomeprazole | Esomeprazole First, Then Placebo |
|---|---|---|
| Started | 21 | 22 |
| Completed | 20 | 20 |
| Not completed | 1 | 2 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Withdrew: Lost to follow-up | 1 | 1 |
| Milestone | Placebo First, Then Esomeprazole | Esomeprazole First, Then Placebo |
|---|---|---|
| Started | 20 | 20 |
| Completed | 20 | 20 |
| Not completed | 0 | 0 |
| Milestone | Placebo First, Then Esomeprazole | Esomeprazole First, Then Placebo |
|---|---|---|
| Started | 20 | 20 |
| Completed | 18 | 19 |
| Not completed | 2 | 1 |
| Withdrew: Lost to follow-up | 2 | 1 |
(1=none, 7=unbearably severe) difference in nasal symptom scores for the average of the last two weeks of each treatment arm
| score on a scale | Esomeprazole Arm | Placebo Arm |
|---|---|---|
| Total Nasal Symptom Scores | 3.0 (1 to 6) | 3.1 (1 to 6) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Events Occurring While Subject Was on Placebo | 0/37 (0%) | 0/37 (0%) | 0/37 (0%) |
| Events Occurring While Subject Was on Esomeprazole | 0/37 (0%) | 0/37 (0%) | 0/37 (0%) |
| Age, Continuous(years) | Entire Study Population |
|---|---|
| Mean | 44.9 (18 to 80) |
| Sex: Female, Male(Participants) | Entire Study Population |
|---|---|
| Female | 26 |
| Male | 11 |
| Baseline Reflux Score(units on a scale) | Entire Study Population |
|---|---|
| Mean | 4.8 (0 to 11) |
| Number of Patients on Intranasal Corticosteroids(Participants) | Entire Study Population |
|---|---|
| Count of participants | 4 |
| Number of Patients on Oral Antihistamines(Participants) | Entire Study Population |
|---|---|
| Count of participants | 9 |
| Number of Patients on Oral Leukotriene Receptor Antagonists(Participants) | Entire Study Population |
|---|---|
| Count of participants | 5 |
| Number of Patients on Intranasal Antihistamines(Participants) | Entire Study Population |
|---|---|
| Count of participants | 1 |
| Number of Patients on Intranasal Anticholinergics(Participants) | Entire Study Population |
|---|---|
| Count of participants | 2 |
10 further baseline measures are reported on the registry.
The record gives a start of Jun 2005, a primary completion of Mar 2008 and a completion of Mar 2008. It does not say whether these dates are actual or estimated.
Results were first posted in Jun 2019, 11 years 3 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Esomeprazole
University of Texas Southwestern Medical Center →