NCT01960569

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: MinaPharm Pharmaceuticals · Industry
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Not accepted

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

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 ) .

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-01-01
• Completion: 2014-04-01
• First posted: 2013-10-10
• Last updated: 2013-10-10

Locations

1 site across 1 country: Egypt