Topical r-Hirudin ( Thrombexx ) Efficacy in Treatment of Haematomas

r-Hirudin (Thrombexx) Efficacy in Treatment of Haematomas Clinical Trial

Official title:

Single Centre,Randomized,Phase IV Study to Assess the Topical r-Hirudin (Thrombexx)Efficacy in the Patients With Haematomas

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01960569
• Other study ID #: Minpharm07052012
• Status: Unknown status
• Phase: Phase 4
• First received: October 7, 2013
• Last updated: October 9, 2013
• Start date: October 2013
• Est. completion date: April 2014

Study information

• Verified date: October 2013
• Source: MinaPharm Pharmaceuticals
• Contact: Mahmoud Hafez, Professor
• Phone: 002 0100 7566299
• Email: mhafez[@]msn.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 ) .

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 200
• Est. completion date: April 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• Age of patients between 20 and 60 years old.

• Patients with all types of haematoma.

Exclusion Criteria:

• Presence of infected wound requiring hospitalization or surgical intervention.

• History of allergy or hypersensitivity to any of the ingredients.

• Patients with coagulation disorders like haemophilia.

• Patients who are on anticoagulants like Warfarin and Acetylsalicylic acid .

• Patients who are taking digestive enzymes like alfa chemotrypsin.

Related Conditions & MeSH terms

• Hematoma
• r-Hirudin (Thrombexx) Efficacy in Treatment of Haematomas

Intervention

Drug:
• active product ( Thrombexx) assigned to arm 1
Dispense 2-3 cm of cream or gel, 2-3 times per day and carry out a light massage until complete

Other:
• Placebo assigned to arm 2

Locations

Country	Name	City	State
Egypt	Prof. Mahmoud Hafez	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
MinaPharm Pharmaceuticals

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Size of haematoma	Assessment the size of haematoma will be by ruler with unit centimeter(cm) , The ruler will measure the longest 2 intersecting line.	6 months
Primary	Size of oedema	Assessment the size of oedema will be by measurement the circumference in unit centimeter(cm).	6 months
Primary	Severity of Pain	Assessment of pain severity will be by Vas score	6 months
Primary	Change in Colour	Assessment of colour will be by colour grade scale , A=Bluish red , B=Blue ,C= Faint	6 months