Trial record 2 of 56 for:    Tonsillitis

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Yali Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Yali Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01988558
First received: November 3, 2013
Last updated: January 21, 2014
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Recurrent Tonsillitis in Children
Drug: DL - Lactic Acid
Dietary Supplement: Raspberry flavored syrup
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Yali Pharmaceuticals:

Primary Outcome Measures:
  • Safety evaluation - Number of participants with adverse events [ Time Frame: At 90 days post treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Tonsil Size [ Time Frame: Chnge from baseline at 6 months post treatment ] [ Designated as safety issue: No ]
  • Number of Tonsillitis episodes [ Time Frame: Chnge in medical history number of recurrent Tonsillitis episodes within 6 months post treatment ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • QOL Questionnaire [ Time Frame: Chnge from baseline at 90 days post treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: December 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treated Group
Children diagnosed as suffering from recurrent Tonsillitis (at least 4 episodes per year) to receive DL-Lactic acid syrup twice a day for a month.
Drug: DL - Lactic Acid
Treated group to receive DL - Lactic Acid Syrup (Raspberry flavored)
Placebo Comparator: Placebo Group Dietary Supplement: Raspberry flavored syrup
Placebo group to receive Raspberry flavored Syrup

  Eligibility

Ages Eligible for Study:   5 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01988558

Contacts
Contact: Moshe T Neuman, PhD 972-8-9366700 ext 0 moshe@brd.co.il

Locations
Israel
Assaf Harofeh Medical Center Recruiting
Tzrifin, Israel
Principal Investigator: Mati Berkovitz, Prof.         
Sponsors and Collaborators
Yali Pharmaceuticals
Investigators
Principal Investigator: Mati Berkovitz, Prof. MOH
  More Information

No publications provided

Responsible Party: Yali Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01988558     History of Changes
Other Study ID Numbers: LA-001-IL
Study First Received: November 3, 2013
Last Updated: January 21, 2014
Health Authority: Israel: Ministry of Health

Keywords provided by Yali Pharmaceuticals:
Recurrent Tonsillitis
Streptococcus A

Additional relevant MeSH terms:
Tonsillitis
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on October 16, 2014