Therapeutic effectiveness, safety and tolerability of Tonsilotren tabletsin patients (6 to 60 years old) with chronic inflammation of palatine tonsils.A randomized, international, multicenter, controlled clinical trial.
- Conditions
- Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]Chronic tonsillitisMedDRA version: 14.1Level: PTClassification code 10009152Term: Chronic tonsillitisSystem Organ Class: 10021881 - Infections and infestations
- Registration Number
- EUCTR2012-001430-34-DE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 240
1.Males and females aged from 6 to 60 years;
2.Diagnosed chronic tonsillitis characterized by:
-the presence of at least three of five local symptoms at visit 1:
oHyperemia of the anterior palatine arches;
oEdema of angle where the anterior and posterior palatine arches join each other;
oCaseous purulent plug and / or purulent exudates in the tonsillar crypts;
oFriable tonsils or indurated tonsils or scarred adhesions between the tonsils and the palatine arches;
oEnlarged submandibular lymph nodes.
-At least three acute throat infections within the past twelve months, or two acute throat infections during each of the two last years, documented in the patient file;
Definition and criteria for accepted documentation of acute throat infection in the patient file: Diagnoses and / or corresponding codes J02 and J03 according to WHO ICD-10. Also documentation in referral letters is accepted. If exact number of events is not given, information (date and diagnosis of each event) should be obtained by contact with referral person and documented.
3.Signed informed consent according to the applicable law;
4.Willingness and ability to comply with all procedures of the trial.
Are the trial subjects under 18? yes
Number of subjects for this age range: 160
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1.Presence of acute throat infection at inclusion;
2.Presence of peri-tonsillar abscess;
3.Presence of acute and chronic otitis, adenoiditis, sinusitis of all types, odontological infection, bronchial and lung disease (e.g. bronchitis, bronchial asthma, cystic fibrosis), tuberculosis or known allergic manifestations in the throat and / or mouth;
4.Obstruction in the pharynx due to enlargement of tonsils (causing severe sleep disorders e.g. sleep apnea);
5.Presence of severe cardiovascular, renal or hepatic disease, as well as gastroesophageal reflux, unstable diabetes mellitus, hyperthyroidism, cerebrovascular or other active bleeding, Human Immunodeficiency Virus (HIV) infection, mononucleosis of each severity, or oropharyngeal gonorrhea;
6.History of non-steroidal anti-inflammatory drugs (NSAIDs) intolerance (e.g. bronchospasm, asthma, rhinitis, urticaria, gastrointestinal bleeding or perforation), hematogenetic dysfunction of unknown origin, repeated peptic ulcera or hemorrhages;
7.History or presence of all kind of serious streptococcal complications (rheumatic heart disease, glomerulonephritis, joint pain, arthritis);
8.Previous surgery in the past six months or need for surgery of the nose or paranasal sinuses, adenoids and / or tonsils;
9.Evidence of any malignant disease during the past five years before enrolment into the trial;
10.Presence of neurological and / or psychiatric diseases (e.g. depressive episode) interfering with evaluation of quality of life and assessment in the patient's diary;
11.Treatment with systemic acting antibiotics, glucocorticosteroids or medications with immunomodulating activities during the past four weeks and treatment with NSAIDs as well as locally on the tonsils acting antibiotics, glucocorticosteroids or immunomodulators during the past week prior to enrolment into the trial;
12.Known or suspected hypersensitivity to chromium, mercury or any other ingredient and / or excipient of Tonsilotren as well as lactose and / or fructose intolerance and known intolerance towards leather and jewelry metals as well as towards dental metal fillings and vaccines;
13.Heavy smoking (>= 20 cigarettes per day) or known or suspicion to or presence of drug addiction including alcohol abuse;
14.Women of childbearing potential without adequate contraception or women, who want to become pregnant, are pregnant or breast-feeding;
15.Prior enrolment into this trial;
16.Participation in another clinical trial during the past three months prior to enrolment into the trial;
17.Incapability of understanding nature, meaning and consequences of the trial;
18.Patients in custody by juridical or official order;
19.Patients, who are members of the staff of the study center, staff of the sponsor or involved Clinical Research Organizations (CROs), the investigator him- / herself or close relatives of the investigator.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method