Recurrent Tonsillitis in Children Clinical Trial
Official title:
A Phase I/II, Randomized, Double Blind, Placebo-controlled Study to Assess the Safety, Tolerability and Efficacy of DL-lactic Acid Syrup (Tonsitin) in Children With Recurrent Tonsillitis.
| Verified date | October 2016 |
| Source | Yali Pharmaceuticals |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Israel: Ministry of Health |
| Study type | Interventional |
The study objectives are to evaluate Tonsitin™ (10% Lactic Acid) safety, tolerability and preliminary efficacy, as a potent treatment for Recurrent Tonsillitis in children.
| Status | Completed |
| Enrollment | 51 |
| Est. completion date | September 2016 |
| Est. primary completion date | August 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 5 Years to 16 Years |
| Eligibility |
Inclusion Criteria: - Children at the ages of 5-16. - Patient is suffering from recurrent documented sore throat with at least 4 tonsillitis episodes during the preceding year (at least one verified by culture or rapid antigen testing for Streptococcus A). - Patient with clinical presentation of irregular tonsils. - Tonsils size graded between 2.5-4. - Clinical diagnosis of bacterial known in recurrent pharyngeal-tonsillitis. - Patient is willing to participate in the study and adhere to the study protocol - Patient's guardian and/or Patient have signed informed consent. Exclusion Criteria: - Clinical diagnosis of acute tonsillitis/pharyngitis caused by Streptococcus pyogenes (Positive RSAT or microbial culture). - Subjects who are known as Streptococcus pyogenes carriers - Subject's requiring any other medication (topical or systemic) that may affect the course of the disease during the study period (e.g. antibiotics, sedating antihistamines), and/or did not completed 14 days from end of antibiotics treatment. - Subjects with known hypersensitivity to lactose. - Subject is suffering from peritonsillar abscess. - Subject suffers from an active peptic ulcer - Subjects who are suffering from any concomitant disease which in the judgment of the investigator will interfere with the conduct or interpretation of the study results. - Subject is currently participating in another clinical study. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Israel | Clalit Health Services, Pediatric Community Ambulatory Clinic | Petach Tikva | |
| Israel | Clalit Health Services, Pediatric Community Ambulatory Ganei Hadar clinic | Petach Tikva | |
| Israel | Assaf Harofeh Medical Center | Tzrifin |
| Lead Sponsor | Collaborator |
|---|---|
| Yali Pharmaceuticals |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | QOL Questionnaire | Chnge from baseline at 90 days post treatment | No | |
| Primary | Safety evaluation - Number of participants with adverse events | At 90 days post treatment | Yes | |
| Secondary | Tonsil Size | Chnge from baseline at 6 months post treatment | No | |
| Secondary | Number of Tonsillitis episodes | Chnge in medical history number of recurrent Tonsillitis episodes within 6 months post treatment | No |