Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT01198912
Status:
COMPLETED
Last Update Posted:
2018-06-15
First Post:
2010-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009298', 'term': 'Nasal Polyps'}, {'id': 'D000096825', 'term': 'Rhinosinusitis'}], 'ancestors': [{'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D011127', 'term': 'Polyps'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012852', 'term': 'Sinusitis'}, {'id': 'D010254', 'term': 'Paranasal Sinus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004318', 'term': 'Doxycycline'}], 'ancestors': [{'id': 'D013754', 'term': 'Tetracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2017-02-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-14', 'studyFirstSubmitDate': '2010-09-08', 'studyFirstSubmitQcDate': '2010-09-09', 'lastUpdatePostDateStruct': {'date': '2018-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Endoscopic evaluation of quality and speed of wound healing', 'timeFrame': 'at 3 months after first drug intake'}, {'measure': 'Recurrence of nasal polyps', 'timeFrame': 'at 3 months after first drug intake'}, {'measure': 'Recurrence of nasal polyps', 'timeFrame': 'at 6 months after first drug intake'}], 'secondaryOutcomes': [{'measure': 'nasal and exhaled NO', 'timeFrame': 'at 3 months after first drug intake'}, {'measure': 'nasal and exhaled NO', 'timeFrame': 'at 6 months after first drug intake'}, {'measure': 'subjective assessment of the wound healing', 'timeFrame': 'at 3 months after first drug intake'}, {'measure': 'subjective assessment of the wound healing', 'timeFrame': 'at 6 months after first drug intake'}, {'measure': 'chronic rhinosinusitis symptoms by the patients', 'timeFrame': 'at 3 months after first drug intake'}, {'measure': 'chronic rhinosinusitis symptoms by the patients', 'timeFrame': 'at 6 months after first drug intake'}, {'measure': 'Questionnaires: SNOT 22, RSOM, SF36 asthma control questionnaire', 'timeFrame': 'at 3 months after first drug intake'}, {'measure': 'Questionnaires: SNOT 22, RSOM, SF36 asthma control questionnaire', 'timeFrame': 'at 6 months after first drug intake'}, {'measure': 'inflammatory mediators in nasal fluid as well as in serum', 'timeFrame': 'at 3 months after first drug intake'}, {'measure': 'inflammatory mediators in nasal fluid as well as in serum', 'timeFrame': 'at 6 months after first drug intake'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['rhinosinusitis', 'doxycycline', 'Chronic rhinosinusitis with or without nasal polyps'], 'conditions': ['Chronic Rhinosinusitis', 'Nasal Polyps']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.uzgent.be', 'label': 'website University Hospital Ghent, Belgium'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized, double blind, placebo controlled, parallel group, study in patients with chronic rhinosinusitis with or without nasal polyps. The objective is to test the clinical efficacy of long-term low dose oral doxycycline on wound healing quality after endoscopic sinus surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* at least 18 years of age, of either sex and any race\n* diagnosis of chronic rhinosinusitis with or without nasal polyposis according to the EPOS guidelines research\n* Subjects should be regularly scheduled for bilateral functional endonasal endoscopic sinus surgery\n* 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.\n* Subjects must be willing to give informed consent and adhere to visit schedules, medication restrictions, and agree to perform daily diary entries.\n* Nonpregnant women of childbearing potential must use a medically acceptable, adequate form of birth control.\n\nExclusion Criteria:\n\n* Women must not be pregnant, breast feeding, or premenarcheal.\n* Subjects who have required oral corticosteroids within the previous four weeks prior to surgery.\n* Subjects who have required nasal corticosteroids within the previous one week prior to surgery.\n* 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.\n* Patients with the following diseases should be excluded :\n\n 1. Cystic fibrosis based on positive sweat test or DNA alleles\n 2. Gross immunodeficiency (congenital or acquired)\n 3. congenital mucociliary problems e.g. primary ciliary dyskinesia (PCD)\n 4. Non-invasive fungal balls and invasive fungal disease\n 5. systemic vasculitis and granulomatous diseases\n 6. Cocaine abuse\n 7. Neoplasia'}, 'identificationModule': {'nctId': 'NCT01198912', 'acronym': 'DOXYPOSTOP', 'briefTitle': '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', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': '2010/384'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'doxycycline 100 mg', 'interventionNames': ['Drug: doxycycline 100 mg']}], 'interventions': [{'name': 'placebo', 'type': 'DRUG', 'description': 'during 56 days', 'armGroupLabels': ['placebo']}, {'name': 'doxycycline 100 mg', 'type': 'DRUG', 'description': 'during 56 days', 'armGroupLabels': ['doxycycline 100 mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ghent', 'country': 'Belgium', 'facility': 'University Hospital Ghent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'city': 'Bochum', 'country': 'Germany', 'facility': 'Univ.-HNO-Klinik, St. Elisabeth Hospital', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}], 'overallOfficials': [{'name': 'Claus Bachert, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Ghent, Belgium'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}