Trial | NCT01595360  Report issue

Title

Safety, Tolerability and Efficacy Study of TT-173 in Healthy Volunteers After Tooth Extraction
A Phase 1, Randomized, Open, Controlled, Comparative Safety, Tolerability and Efficacy Study of TT-173 in Healthy Volunteers After Tooth Extraction

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    tt-173 ...

  • Study Participants

    24
The purpose of this study is to evaluate the safety, tolerability and efficacy of TT-173 in healthy volunteers after tooth extraction.
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.
Study Started
Apr 30
2012
Primary Completion
Sep 30
2013
Study Completion
Sep 30
2013
Last Update
Sep 16
2013
Estimate

Drug Placebo

It is applied directly to the bleeding site after tooth extraction

Drug TT-173

It is applied directly to the bleeding site after tooth extraction

Placebo Placebo Comparator

Placebo

TT-173 Experimental

TT-173

Criteria 

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.
No Results Posted