Safety, Tolerability and Efficacy Study of TT-173 in Healthy Volunteers After Tooth Extraction
This study is currently recruiting participants.
Verified May 2012 by Thrombotargets Europe S.L
Sponsor:
Thrombotargets Europe S.L
Information provided by (Responsible Party):
Thrombotargets Europe S.L
ClinicalTrials.gov Identifier:
NCT01595360
First received: May 3, 2012
Last updated: May 22, 2012
Last verified: May 2012
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Purpose
The purpose of this study is to evaluate the safety, tolerability and efficacy of TT-173 in healthy volunteers after tooth extraction.
| Condition | Intervention | Phase |
|---|---|---|
|
Tooth Extraction |
Drug: Placebo Drug: TT-173 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1, Randomized, Open, Controlled, Comparative Safety, Tolerability and Efficacy Study of TT-173 in Healthy Volunteers After Tooth Extraction |
Further study details as provided by Thrombotargets Europe S.L:
Primary Outcome Measures:
- Number of Adverse Events [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Cmax, Tmax, AUC and bioavailability [ Time Frame: 48 h ] [ Designated as safety issue: No ]
- Determine the presence of coagulation disorders [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]Blood platelets, Prothrombin time, Fibrinogen, Thrombin time
- Determine the immune responses to TT-173 [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]Antibody concentration
- Time to hemostasis until cessation of bleeding [ Time Frame: time 0 until cessation of bleeding ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 24 |
| Study Start Date: | April 2012 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
Placebo
|
Drug: Placebo
It is applied directly to the bleeding site after tooth extraction
|
|
Experimental: TT-173
TT-173
|
Drug: TT-173
It is applied directly to the bleeding site after tooth extraction
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01595360
Contacts
| Contact: Ramon Lopez | +34 936642040 | ramonlopez@thrombotargets.com |
Locations
| Spain | |
| Thrombotargets Europe SL | Recruiting |
| Castelldefels, Barcelona, Spain, 08860 | |
| Contact: Ramon Lopez +34 93 6642040 ramonlopez@thrombotargets.com | |
Sponsors and Collaborators
Thrombotargets Europe S.L
More Information
Additional Information:
No publications provided
| Responsible Party: | Thrombotargets Europe S.L |
| ClinicalTrials.gov Identifier: | NCT01595360 History of Changes |
| Other Study ID Numbers: | 2010-021882-57 |
| Study First Received: | May 3, 2012 |
| Last Updated: | May 22, 2012 |
| Health Authority: | Spain: Agencia Española de Medicamentos y Productos Sanitarios Spain: Ethics Committee |
Keywords provided by Thrombotargets Europe S.L:
|
TT-173 Topical Hemostatics Hemostasis |
ClinicalTrials.gov processed this record on May 19, 2013