Influence of Oral Doxycycline on Wound Healing After Endonasal Endoscopic Sinus Surgery for Chronic Rhinosinusitis With and Without Nasal Polyposis: a Double-blind Randomized Placebo-controlled Trial
NCT ID: NCT01198912
Last Updated: 2018-06-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
33 participants
INTERVENTIONAL
2011-11-22
2017-02-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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placebo
placebo
during 56 days
doxycycline 100 mg
doxycycline 100 mg
during 56 days
Interventions
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placebo
during 56 days
doxycycline 100 mg
during 56 days
Eligibility Criteria
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Inclusion Criteria
* diagnosis of chronic rhinosinusitis with or without nasal polyposis according to the EPOS guidelines research
* Subjects should be regularly scheduled for bilateral functional endonasal endoscopic sinus surgery
* Subjects must be in good health, free of any clinically significant disease that would interfere with the study schedule or procedures or compromise his/her safety.
* Subjects must be willing to give informed consent and adhere to visit schedules, medication restrictions, and agree to perform daily diary entries.
* Nonpregnant women of childbearing potential must use a medically acceptable, adequate form of birth control.
Exclusion Criteria
* Subjects who have required oral corticosteroids within the previous four weeks prior to surgery.
* Subjects who have required nasal corticosteroids within the previous one week prior to surgery.
* Subjects with known allergic reaction on tetracyclines, diabetes (type 1 and 2), renal insufficiency, severe liver disease, systemic diseases affecting the nose (e.g. M. Wegener), prior surgeries of the paranasal sinuses.
* Patients with the following diseases should be excluded :
1. Cystic fibrosis based on positive sweat test or DNA alleles
2. Gross immunodeficiency (congenital or acquired)
3. congenital mucociliary problems e.g. primary ciliary dyskinesia (PCD)
4. Non-invasive fungal balls and invasive fungal disease
5. systemic vasculitis and granulomatous diseases
6. Cocaine abuse
7. Neoplasia
18 Years
ALL
No
Sponsors
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University Hospital, Ghent
OTHER
Responsible Party
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Principal Investigators
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Claus Bachert, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Ghent, Belgium
Locations
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University Hospital Ghent
Ghent, , Belgium
Univ.-HNO-Klinik, St. Elisabeth Hospital
Bochum, , Germany
Countries
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Related Links
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website University Hospital Ghent, Belgium
Other Identifiers
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2010/384
Identifier Type: -
Identifier Source: org_study_id
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