Status:
COMPLETED
Sinuclean's Treatment Of Sinusitis' Symptoms
Lead Sponsor:
Galsor S.r.l.
Conditions:
Sinusitis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The goal of the study is to demonstrate that SINUclean DM® spray, added to the standard (amoxicillin/clavulanate) therapy of the acute episode of sinusitis (acute, subacute or chronic), is safe ad cap...
Detailed Description
The randomized subject with diagnosis of acute episode of sinusitis with symptoms and mucus in the paranasal sinuses, will treat his/her condition with background amoxicillin/clavulanate and with inha...
Eligibility Criteria
Inclusion
- Male or female sex.
- Age \> 18 years old.
- Diagnosis of acute episode of sinusitis (in an acute, subacute or chronic background), confirmed with a CT scan image.
- Presence of mucus in para-nasal sinuses.
- Symptoms of facial pain associated to the congestion of the mucosa of the paranasal sinuses for at least three days.
- Written informed consent.
- Expressed intention of compliance with the study requirements.
Exclusion
- In case of female subject: ongoing pregnancy or lactating; or condition of fecundity without abstinence.
- Assumption, during the study, of drugs that can interfere with the evaluation of the investigational drug (see Section "Concomitant Therapy")
- Possible necessity of treatment, during the study, with drugs that are not allowed (see section "Concomitant Therapy").
- Clinical conditions (systemic pathologies or other) that can interfere with the assessment of the safety and efficacy of the investigational drug, in example: viral or allergic rhinitis with active secretive symptomatology, presence of visible nasal polyps, diagnosis of immobile cilia syndrome, diseases determining immunodeficiency cystic fibrosis immunocompromission renal insufficiency, dialysis, pathology of other apparatus that, in the opinion of the investigator, necessity of a supplementary antibiotic therapy,due to other pathologies, besides the one standard of the sinusitis.
- Psychical conditions not compatible with the participation to the clinical trial.
- Alcohol abuse or other dependencies on stupefacents
- Smoking during the period of the study
- History of intolerance or allergy to the components of SINUclean DM®
- Surgical or medical intervention that can jeopardize the complete performance of the trial, in the 4 wks preceding the administration of the informed consent
- Planning of a surgical or medical intervention that can jeopardize the completion of the trial
- Participation to other clinical trials, ongoing or terminated since less than 30 days before the beginning of the present experiment.
- Preceding randomization in this trial.
- Be component of the investigators' staff or be a relative of a member of the staff.
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00747747
Start Date
November 1 2007
End Date
February 1 2010
Last Update
March 14 2012
Active Locations (1)
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1
University Cattolica del Sacro Cuore
Rome, Lazio, Italy, 00168