Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-25 @ 8:19 PM
Study NCT ID:
NCT01960569
Status:
UNKNOWN
Last Update Posted:
2013-10-10
First Post:
2013-10-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Topical r-Hirudin ( Thrombexx ) Efficacy in Treatment of Haematomas
Sponsor:
MinaPharm Pharmaceuticals
Organization:
Study Overview
Official Title:
Single Centre,Randomized,Phase IV Study to Assess the Topical r-Hirudin (Thrombexx)Efficacy in the Patients With Haematomas
Status:
UNKNOWN
Status Verified Date:
2013-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Single centre ,Phase IV , interventional, The study includes :
200 patients, 100 Patients will have Topical r-Hirudin (Thrombexx) and 100 patients will have placebo .
The patients will be randomized to the active product (arm 1) or to placebo (arm 2).
The study consists of 4 visits as the following :
* Visit 1 : on day 1 to check patient eligibility and also for randomization .
* Visit 2 : on day 4 to assess target parameters
* Visit 3 : on day 8 to assess target parameters
* Visit 4 : on day 16 to assess target parameters
200 patients, 100 Patients will have Topical r-Hirudin (Thrombexx) and 100 patients will have placebo .
The patients will be randomized to the active product (arm 1) or to placebo (arm 2).
The study consists of 4 visits as the following :
* Visit 1 : on day 1 to check patient eligibility and also for randomization .
* Visit 2 : on day 4 to assess target parameters
* Visit 3 : on day 8 to assess target parameters
* Visit 4 : on day 16 to assess target parameters
Detailed Description:
Single centre ,Phase IV , interventional, The study includes :
\* 200 patients, 100 Patients will have Topical r-Hirudin (Thrombexx) and 100 patients will have placebo .
The patients will be randomized to the active product (arm 1) or to placebo (arm 2).
The study consists of 4 visits as the following :
* Visit 1 : on day 1 to check patient eligibility and also for randomization .
* Visit 2 : on day 4 to assess target parameters
* Visit 3 : on day 8 to assess target parameters
* Visit 4 : on day 16 to assess target parameters
* Study objective :Assessment the Efficacy of Topical r-Hirudin in treatment of haematomas ,also in resolving of the associated oedema
* Study duration : 6 months
* Selection of trial subjects:
Inclusion Criteria :
1. Age of patients between 20 and 60 years old.
2. Patients with all types of haematomas.
Exclusion Criteria:
1. Presence of infected wound requiring hospitalization or surgical intervention.
2. History of allergy or hypersensitivity to any of the ingredients.
3. Patients with coagulation disorders like haemophilia.
4. Patients who are on anticoagulants like Warfarin and Acetylsalicylic acid .
5. Patients who are taking digestive enzymes like alfa chemotrypsin.
* Target parameters :
1.Size of haematoma.( Measured by ruler) , The ruler will measure the longest 2 intersecting line.
2.Size of oedema : by measurement of oedema circumference
3.Pain (by Vas score).
4.Change in colour ( by colour grade scale ) .
\* 200 patients, 100 Patients will have Topical r-Hirudin (Thrombexx) and 100 patients will have placebo .
The patients will be randomized to the active product (arm 1) or to placebo (arm 2).
The study consists of 4 visits as the following :
* Visit 1 : on day 1 to check patient eligibility and also for randomization .
* Visit 2 : on day 4 to assess target parameters
* Visit 3 : on day 8 to assess target parameters
* Visit 4 : on day 16 to assess target parameters
* Study objective :Assessment the Efficacy of Topical r-Hirudin in treatment of haematomas ,also in resolving of the associated oedema
* Study duration : 6 months
* Selection of trial subjects:
Inclusion Criteria :
1. Age of patients between 20 and 60 years old.
2. Patients with all types of haematomas.
Exclusion Criteria:
1. Presence of infected wound requiring hospitalization or surgical intervention.
2. History of allergy or hypersensitivity to any of the ingredients.
3. Patients with coagulation disorders like haemophilia.
4. Patients who are on anticoagulants like Warfarin and Acetylsalicylic acid .
5. Patients who are taking digestive enzymes like alfa chemotrypsin.
* Target parameters :
1.Size of haematoma.( Measured by ruler) , The ruler will measure the longest 2 intersecting line.
2.Size of oedema : by measurement of oedema circumference
3.Pain (by Vas score).
4.Change in colour ( by colour grade scale ) .
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: