MedTrace Logo

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

NCT01960569 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2013-10-10

No results posted yet for this study

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

Conditions

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

Interventions

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

Sponsors & Collaborators

  • MinaPharm Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Mahmoud Hafez, Professor · 6th October university

  • Ahmed Moneer, Dr · 6th october university

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2014-01-31
Completion
2014-04-30

Countries

  • Egypt

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01960569 on ClinicalTrials.gov