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

Tooth Extraction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01595360
• Other study ID #: 2010-021882-57
• Status: Completed
• Phase: Phase 1
• First received: May 3, 2012
• Last updated: September 13, 2013
• Start date: April 2012
• Est. completion date: September 2013

Study information

• Verified date: September 2013
• Source: Thrombotargets Europe S.L
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos SanitariosSpain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tooth Extraction

Intervention

Drug:
• Placebo
It is applied directly to the bleeding site after tooth extraction
• TT-173
It is applied directly to the bleeding site after tooth extraction

Locations

Country	Name	City	State
Spain	Thrombotargets Europe SL	Castelldefels	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Thrombotargets Europe S.L

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Adverse Events		4 months	Yes
Secondary	Cmax, Tmax, AUC and bioavailability		48 h	No
Secondary	Determine the presence of coagulation disorders	Blood platelets, Prothrombin time, Fibrinogen, Thrombin time	4 months	Yes
Secondary	Determine the immune responses to TT-173	Antibody concentration	4 months	Yes
Secondary	Time to hemostasis until cessation of bleeding		time 0 until cessation of bleeding	No

External Links

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