NCT01960569

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2013

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 10, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

October 10, 2013

Status Verified

October 1, 2013

Enrollment Period

3 months

First QC Date

October 7, 2013

Last Update Submit

October 9, 2013

Conditions

r-Hirudin (Thrombexx) Efficacy in Treatment of Haematomas

Keywords

ThrombexxTopical r-HirudinEfficacyhaematoma

Outcome Measures

Primary Outcomes (4)

  • 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

  • Size of oedema

    Assessment the size of oedema will be by measurement the circumference in unit centimeter(cm).

    6 months

  • Severity of Pain

    Assessment of pain severity will be by Vas score

    6 months

  • Change in Colour

    Assessment of colour will be by colour grade scale , A=Bluish red , B=Blue ,C= Faint

    6 months

Study Arms (2)

Arm 1 : active product (Thrombexx)

ACTIVE COMPARATOR

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

Arm 2 : Placebo

PLACEBO COMPARATOR

100 patients will have placebo , their visits on days 1,4,8 and 16 for target parameters assessment

Other: Placebo assigned to arm 2

Interventions

active product ( Thrombexx) assigned to arm 1DRUG

Dispense 2-3 cm of cream or gel, 2-3 times per day and carry out a light massage until complete

Also known as: Topical r-Hirudin
Arm 1 : active product (Thrombexx)
Placebo assigned to arm 2OTHER
Arm 2 : Placebo

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age of patients between 20 and 60 years old.
  • Patients with all types of haematoma.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prof. Mahmoud Hafez

Cairo, Cairo Governorate, Egypt

RECRUITING

Related Publications (1)

  • El-Mowafi H, El Araby A, Kandil Y, Zaghloul A. Randomized, double-blind, placebo-controlled, interventional phase IV investigation to assess the efficacy and safety of r-hirudin gel (1120I.U) in patients with hematomas. Res Pract Thromb Haemost. 2017 Nov 6;2(1):139-146. doi: 10.1002/rth2.12049. eCollection 2018 Jan.

    PMID: 30046714DERIVED

MeSH Terms

Conditions

Hematoma

Condition Hierarchy (Ancestors)

HemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mahmoud Hafez, Professor

    6th October university

    PRINCIPAL INVESTIGATOR

  • Ahmed Moneer, Dr

    6th october university

    STUDY CHAIR

Central Study Contacts

Mahmoud Hafez, Professor

CONTACT

002 0100 7566299mhafez@msn.com

Moustafa Sameer, Dr

CONTACT

002 0100 6016 212msameer@minapharm.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2013

First Posted

October 10, 2013

Study Start

October 1, 2013

Primary Completion

January 1, 2014

Study Completion

April 1, 2014

Last Updated

October 10, 2013

Record last verified: 2013-10

Locations

EG(1)