Ignite Creation Date:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2026-02-21 @ 9:59 PM
Study NCT ID:
NCT02178293
Status:
COMPLETED
Last Update Posted:
2014-07-08
First Post:
2014-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ketoprofen Lysine Salt as Mouthwash in Acute Phlogosis of the Pharyngeal Cavity Versus Benzidamine Hydrochloride
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010612', 'term': 'Pharyngitis'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 214}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'lastUpdateSubmitDate': '2014-07-04', 'studyFirstSubmitDate': '2014-06-27', 'studyFirstSubmitQcDate': '2014-06-27', 'lastUpdatePostDateStruct': {'date': '2014-07-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '1999-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of analgesic effects in hours', 'timeFrame': 'Up to 6 hours'}], 'secondaryOutcomes': [{'measure': 'Average number of days required to obtain remission of pain', 'timeFrame': 'Up to day 8', 'description': 'day on which 2 consecutive pain measurements are both below 10 mm of the visual analog scale (VAS)'}, {'measure': 'Average severity of edema and hyperemia, assessed by investigator on a 4-point-scale', 'timeFrame': 'Up to day 8'}]}, 'conditionsModule': {'conditions': ['Pharyngitis']}, 'descriptionModule': {'briefSummary': 'A study to in order to verify any differences between the 2 treatment groups in terms of duration of analgesic effects after the first drug intake and time to remission of symptoms and signs of pharyngitis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female outpatients, aged 18 to 70 years, suffering from acute pharyngitis, pharyngolaryngitis\n* Moderately or severely intense pain in the pharyngeal region (score ≥ 70 mm) from the "visual analogue scale" (VAS)\n* At least 1 of the 2 inflammation signs (edema and hyperemia) to be moderately or severely intense (score ≥ 2) from the scoring scale from 0 to 3\n* Release of written informed consent by the patient\n\nExclusion Criteria:\n\n* Patients suffering from a microbial infection requiring specific antimicrobial treatment\n* Patients who have taken the trial drugs during the week before enrolment\n* Patients who have taken corticosteroids or antibiotics during the week before enrolment\n* Ascertained or suspected hypersensitivity to trial drugs or to chemically correlated drugs or to other non-steroidal anti-inflammatory drugs or to mouthwashes in general\n* Patients who are unable to properly fill in the diary every day as provided for by the protocol\n* Ascertained or presumed pregnant or lactating women\n* Inclusion in any other clinical trial during the study'}, 'identificationModule': {'nctId': 'NCT02178293', 'acronym': 'MISTRAL', 'briefTitle': 'Ketoprofen Lysine Salt as Mouthwash in Acute Phlogosis of the Pharyngeal Cavity Versus Benzidamine Hydrochloride', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'MISTRAL (Mouthwash In Sore Throat Relief: Antiinflammatory vs. Local Anesthetic Therapy) "Efficacy and Tolerability of Ketoprofen Lysine Salt as a Mouthwash in Acute Phlogosis of the Pharyngeal Cavity; Multicentre, Randomized, Single-blind, Parallel-group Comparison Versus Benzidamine Hydrochloride"', 'orgStudyIdInfo': {'id': '1087.7'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Benzidamine hydrochloride', 'interventionNames': ['Drug: Benzidamine hydrochloride']}, {'type': 'EXPERIMENTAL', 'label': 'Ketoprofen lysine salt', 'interventionNames': ['Drug: Ketoprofen lysine salt']}], 'interventions': [{'name': 'Benzidamine hydrochloride', 'type': 'DRUG', 'armGroupLabels': ['Benzidamine hydrochloride']}, {'name': 'Ketoprofen lysine salt', 'type': 'DRUG', 'armGroupLabels': ['Ketoprofen lysine salt']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}