Clinical trial NCT01988558: A Phase I/II to Assess Safety, Tolerability and Efficacy of DL-lactic Acid Syrup in Children With Recurrent Tonsillitis
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Recurrent Tonsillitis in Children
Keywords: Recurrent Tonsillitis
Streptococcus A
Lead sponsor: Yali Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2013-11-20
Enrollment: 51
Sex: ALL
Minimum age (years): 5
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study objectives are to evaluate Tonsitin™ (10% Lactic Acid) safety, tolerability and preliminary efficacy, as a potent treatment for Recurrent Tonsillitis in children.


Eligibility criteria: 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.

Primary outcomes:
measure: Safety evaluation - Number of participants with adverse events
timeFrame: At 90 days post treatment
Secondary outcomes:
measure: Tonsil Size
timeFrame: Chnge from baseline at 6 months post treatment
measure: Number of Tonsillitis episodes
timeFrame: Chnge in medical history number of recurrent Tonsillitis episodes within 6 months post treatment
Other outcomes:
measure: QOL Questionnaire
timeFrame: Chnge from baseline at 90 days post treatment
Locations:
city: Petach Tikva
country: Israel
facility: Clalit Health Services, Pediatric Community Ambulatory Clinic
city: Petach Tikva
country: Israel
facility: Clalit Health Services, Pediatric Community Ambulatory Ganei Hadar clinic
city: Tzrifin
country: Israel
facility: Assaf Harofeh Medical Center
Study officials:
affiliation: MOH
name: Mati Berkovitz, Prof.
role: PRINCIPAL_INVESTIGATOR
References: