A Phase I/II to Assess Safety, Tolerability and Efficacy of DL-lactic Acid Syrup in Children With Recurrent Tonsillitis

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yali Pharmaceuticals

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.