Safety, Tolerability and Efficacy Study of TT-173 in Healthy Volunteers After Tooth Extraction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-09-30

Brief Summary

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The purpose of this study is to evaluate the safety, tolerability and efficacy of TT-173 in healthy volunteers after tooth extraction.

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Detailed Description

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As the TT-113 has been cleared for use as a topical hemostatic agent, the proposed study will further investigate the safety, tolerability and efficacy of TT-113 in healthy volunteers after tooth extraction.

Conditions

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Tooth Extraction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

It is applied directly to the bleeding site after tooth extraction

TT-173

Group Type EXPERIMENTAL

TT-173

Intervention Type DRUG

It is applied directly to the bleeding site after tooth extraction

Interventions

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Placebo

It is applied directly to the bleeding site after tooth extraction

Intervention Type DRUG

TT-173

It is applied directly to the bleeding site after tooth extraction

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects to be undertaken for the simple extraction of at least one tooth (incisor, canine, premolar, molar different of third molar) that cause bloody wound, located in the upper or inferior maxillary area of the mouth either
* Subjects who are able and willing to provide written and signed informed consent
* All subjects willing to use a medically accepted form of contraception from the time of consent to completion of all follow-up study visits. Negative pregnancy test result in the screening visit.

Exclusion Criteria

* Subjects with personal and family history that could affect correct hemostasis
* Subjects with any clinically-significant coagulation disorder including including deficiencies in any of coagulation factors, thrombocytopenia and vascular purpura
* Subject with hipersensivity of TT-173 of any of its components or has a known allergy.
* Subjects who are unable to adequately follow or understand the instructions and requirements of the study.
* Subjects that are not fully free to give informed consent, or any other obstacle in the opinion of investigator support the conclusion that the subject is not fully reasoned.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes