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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by MinaPharm Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
MinaPharm Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01960569
First received: October 7, 2013
Last updated: October 9, 2013
Last verified: October 2013
  Purpose

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

Condition Intervention Phase
r-Hirudin (Thrombexx) Efficacy in Treatment of Haematomas
Drug: active product ( Thrombexx) assigned to arm 1
Other: Placebo assigned to arm 2
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Single Centre,Randomized,Phase IV Study to Assess the Topical r-Hirudin (Thrombexx)Efficacy in the Patients With Haematomas

Further study details as provided by MinaPharm Pharmaceuticals:

Primary Outcome Measures:
  • Size of haematoma [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Assessment the size of haematoma will be by ruler with unit centimeter(cm) , The ruler will measure the longest 2 intersecting line.

  • Size of oedema [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Assessment the size of oedema will be by measurement the circumference in unit centimeter(cm).

  • Severity of Pain [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Assessment of pain severity will be by Vas score

  • Change in Colour [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Assessment of colour will be by colour grade scale , A=Bluish red , B=Blue ,C= Faint


Estimated Enrollment: 200
Study Start Date: October 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1 : active product (Thrombexx)
100 patients will have the active product(Thrombexx), their visits on days 1,4,8 and 16 for target parameters assessment
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 Name: Topical r-Hirudin
Placebo Comparator: Arm 2 : Placebo
100 patients will have placebo , their visits on days 1,4,8 and 16 for target parameters assessment
Other: Placebo assigned to arm 2

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 ) .

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01960569

Contacts
Contact: Mahmoud Hafez, Professor 002 0100 7566299 mhafez@msn.com
Contact: Moustafa Sameer, Dr 002 0100 6016 212 msameer@minapharm.com

Locations
Egypt
Prof. Mahmoud Hafez Recruiting
Cairo, Egypt
Contact: Ahmed Moneer, Dr    002 0100 8608676    dr_ahmedmoneer@yahoo.com   
Principal Investigator: Mahmoud Hafez, Professor         
Sponsors and Collaborators
MinaPharm Pharmaceuticals
Investigators
Principal Investigator: Mahmoud Hafez, Professor 6th October university
Study Chair: Ahmed Moneer, Dr 6th october university
  More Information

No publications provided

Responsible Party: MinaPharm Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01960569     History of Changes
Other Study ID Numbers: Minpharm07052012
Study First Received: October 7, 2013
Last Updated: October 9, 2013
Health Authority: Egypt: Ministry of Health and Population
Egypt: Institutional Review Board

Keywords provided by MinaPharm Pharmaceuticals:
Thrombexx
Topical r-Hirudin
Efficacy
haematoma

Additional relevant MeSH terms:
Hematoma
Hemorrhage
Pathologic Processes
Hirudins
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Anticoagulants

ClinicalTrials.gov processed this record on July 26, 2014