Ignite Creation Date:
2024-05-05 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 9:54 AM
Study NCT ID:
NCT00747747
Status:
COMPLETED
Last Update Posted:
2012-03-14
First Post:
2008-09-04
Brief Title:
Sinucleans Treatment Of Sinusitis Symptoms
Sponsor:
Galsor Srl
Organization:
Galsor Srl
Study Overview
Official Title:
Safety and Efficacy for Symptoms Remission of the Treatment of the Acute Episode of Sinusitis With Ecballium Elaterium SINUclean DM Nasal Spray as Co-adjuvant of the Antibiotic Therapy Comparative Prospective Randomized Open Study
Status:
COMPLETED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SToSS
Brief Summary:
The goal of the study is to demonstrate that SINUclean DM spray added to the standard amoxicillinclavulanate therapy of the acute episode of sinusitis acute subacute or chronic is safe ad capable to determine the resolution of the symptoms in a shorter time in comparison with the standard therapy without co-adjuvant or with simple saline lavage
Detailed Description:
The randomized subject with diagnosis of acute episode of sinusitis with symptoms and mucus in the paranasal sinuses will treat hisher condition with background amoxicillinclavulanate and with inhalation of Sinuclean or Saline while the control group will not use any spray for symptom relief Anti-histaminic steroidal anti-inflammatory drugs are forbidden The patient is requested to evaluate his state of symptoms by recording in a diary
the pain or feeling of facial oppression
nasal dripping anterior or posterior
nasal congestion SCALE 0 no symptom
1 mild symptom clearly perceptible but easily tolerated
2 moderate symptom clear awareness of the symptom that is annoying but tolerable
3 severe symptom very annoying difficult to tolerate interfering with the ordinary life Four measures per day 2 for administration of the therapy - beforeafter of which the median will be used plus an evening measure retrospective of the past 12 hours
If possible it will be assessed the status of paranasal sinuses before and after the treatment with a CT scan
The treatment intervals is the week After baseline and start of treatment are planned two control visit The subject will complete the study at the first control visit without symptoms After the second visit if the symptoms are still present the subject will complete as a treatment-failure
the pain or feeling of facial oppression
nasal dripping anterior or posterior
nasal congestion SCALE 0 no symptom
1 mild symptom clearly perceptible but easily tolerated
2 moderate symptom clear awareness of the symptom that is annoying but tolerable
3 severe symptom very annoying difficult to tolerate interfering with the ordinary life Four measures per day 2 for administration of the therapy - beforeafter of which the median will be used plus an evening measure retrospective of the past 12 hours
If possible it will be assessed the status of paranasal sinuses before and after the treatment with a CT scan
The treatment intervals is the week After baseline and start of treatment are planned two control visit The subject will complete the study at the first control visit without symptoms After the second visit if the symptoms are still present the subject will complete as a treatment-failure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EudraCT 2007-003739-22 | OTHER | Sponsor Galsor srl | None |