Recurrent Tonsillitis in ChildrenPhase 1/2NCT01988558
A Phase I/II to Assess Safety, Tolerability and Efficacy of DL-lactic Acid Syrup in Children With Recurrent Tonsillitis
A Phase 1/2 study testing DL - Lactic Acid and Raspberry flavored syrup in people with Recurrent Tonsillitis in Children, run by Yali Pharmaceuticals at 3 sites in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 16 years
- Conditions the study is for
- Recurrent Tonsillitis in Children
- What is being tested?
- DL - Lactic Acid and Raspberry flavored syrup
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 3 sitesIsrael
- Study dates
- Dec 2013to Sep 2016
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Israel3 sites
Clalit Health Services, Pediatric Community Ambulatory Clinic
Petah Tikva, Israel
Clalit Health Services, Pediatric Community Ambulatory Ganei Hadar clinic
Petah Tikva, Israel
Assaf Harofeh Medical Center
Tzrifin
About this study
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.
The study objectives are to evaluate Tonsitin™ (10% Lactic Acid) safety, tolerability and preliminary efficacy, as a potent treatment for Recurrent Tonsillitis in children.
- Conditions
- Recurrent Tonsillitis in Children
- Being tested
- DL - Lactic Acid, Raspberry flavored syrup
- Keywords
- Recurrent Tonsillitis, Streptococcus A
- Medical subject headings
- Tonsillitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DL - Lactic AcidDrug
Treated group to receive DL - Lactic Acid Syrup (Raspberry flavored)
Raspberry flavored syrupDietary supplement
Placebo group to receive Raspberry flavored Syrup
| Study group | Role | What they receive |
|---|---|---|
| Treated Group | Experimental | 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. Receives: Drug: DL - Lactic Acid |
| Placebo Group | Placebo comparator | Not described Receives: Dietary Supplement: Raspberry flavored syrup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety evaluation - Number of participants with adverse events
Measured: At 90 days post treatment
Secondary outcomes (2)
Tonsil Size
Measured: Chnge from baseline at 6 months post treatment
Number of Tonsillitis episodes
Measured: Chnge in medical history number of recurrent Tonsillitis episodes within 6 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2013 (estimated)
- Study startDec 2013
- Primary completionAug 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Tonsillitis in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yali Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mati Berkovitz, Prof., Principal investigator, MOH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01988558
- Sponsor's protocol ID
- LA-001-IL
- Status last verified
- Oct 2016
- First submitted
- 3 Nov 2013
- Last updated
- 7 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01988558
- Acronym / sponsor ID
- LA-001-IL
- Conditions
- Recurrent Tonsillitis in Children
- Keywords
- Recurrent Tonsillitis, Streptococcus A
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Yali PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Aug 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 20 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study objectives are to evaluate Tonsitin™ (10% Lactic Acid) safety, tolerability and preliminary efficacy, as a potent treatment for Recurrent Tonsillitis in children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treated Group | Experimental | Drug: DL - Lactic AcidChildren diagnosed as suffering from recurrent Tonsillitis (at least 4 episodes per year) to receive DL-Lactic acid syrup twice a day for a month. |
| Placebo Group | Placebo comparator | Dietary Supplement: Raspberry flavored syrup |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DL - Lactic AcidTreated group to receive DL - Lactic Acid Syrup (Raspberry flavored) | Drug | Treated Group |
| Raspberry flavored syrupPlacebo group to receive Raspberry flavored Syrup | Dietary supplement | Placebo Group |
Primary outcome
Safety evaluation - Number of participants with adverse events
Time frame: At 90 days post treatment
2 secondary outcomes
Tonsil Size
Time frame: Chnge from baseline at 6 months post treatment
Number of Tonsillitis episodes
Time frame: Chnge in medical history number of recurrent Tonsillitis episodes within 6 months post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mati Berkovitz, Prof. principal investigator
MOH
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DL - Lactic Acid and Raspberry flavored syrup in people with Recurrent Tonsillitis in Children, run by Yali Pharmaceuticals at 3 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety evaluation - Number of participants with adverse events (time frame: At 90 days post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2016.