Trial record 1 of 5 for:    Open Studies | "Thrombophlebitis"
Previous Study | Return to List | Next Study

Efficacy and Tolerability of Hirudoid Cream in Prophylaxis and Treatment Infusion Phlebitis

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2014 by Medinova AG
Sponsor:
Information provided by (Responsible Party):
Medinova AG
ClinicalTrials.gov Identifier:
NCT01943006
First received: September 6, 2013
Last updated: May 15, 2014
Last verified: May 2014
  Purpose

Patients receiving nutritional emulsion for at least 3 days will be treated with Hirudoid cream or placebo cream to prevent and treat phlebitis caused by the infusion. The treatment is continued after the end of infusion for at least 7 days.

Number of patients developing superficial phlebitis and duration of phlebitis will be recorded.


Condition Intervention Phase
Thrombophlebitis
Phlebitis
Drug: Hirudoid cream 0.3 % Mucopolysaccharide polysulfate
Drug: Placebo cream without active substance
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Efficacy and Tolerability of Hirudoid Cream in Prophylaxis and Treatment of Superficial Infusion Thrombophlebitis

Resource links provided by NLM:


Further study details as provided by Medinova AG:

Primary Outcome Measures:
  • Number of patient developing superficial thrombophlebitis [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to develop infusion related superficial thrombophlebitis [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Change of clinical symptoms in patients who developed superficial thrombophlebitis [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Pain score (10-point visual analogue score) Extent of erythema

  • Time to complete resolution of signs and symptoms in patients who developed superficial thrombophlebitis [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Investigators' satisfaction [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    4-point rating scale

  • Patient' satisfaction [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    4-point rating scale

  • Number of adverse events [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    Number of any adverse events and adverse drug reactions including their severity experienced by the patients during the course of therapy

  • Global tolerability [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    Rating of tolerance by investigator and patients using targeted questionnaire 4-point scale (very good, good, moderate, no change or deterioration) at the end of the study


Other Outcome Measures:
  • Fasting blood glucose (FBS) [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    Laboratory test performed on day 1 and at the end of the study

  • Platelet, red blood cell and leukocyte count [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    Laboratory testing is performed on day 1 and end of study

  • Alanine transaminase (ALT), [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    Laboratory testing is performed on day 1 and end of study

  • Aspartate transaminase (AST), [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    Laboratory testing is performed on day 1 and end of study

  • Fibrinogen and activated partial thromboplastin time (aPTT) [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    Laboratory testing is performed on day 1 and end of study

  • Prothrombin time (PT) [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    Laboratory testing is performed on day 1 and end of study

  • Serum creatinine [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    Laboratory testing is performed on day 1 and end of study


Estimated Enrollment: 144
Study Start Date: October 2014
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hirudoid cream

Patient treated with Hirudoid cream 0.3% Mucopolysaccharide polysulfate

Twice daily

Drug: Hirudoid cream 0.3 % Mucopolysaccharide polysulfate
Hirudoid cream
Placebo Comparator: Placebo

Patients treated with placebo cream without active substance

Twice daily

Drug: Placebo cream without active substance

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who are admitted to the hospital requiring to receive infusion of a complete nutritional emulsion for 3 days (Kabiven® Peripheral, 1400 kcal, 1920 ml, 750 mosmol/L, pH 5.6),
  • Aged 18-65 years.
  • Patients who are able to understand the requirements of the study and agree to sign an informed consent, approved by an Independent Ethic Committee (IEC)/Institutional Review Board (IRB), prior to the study.

Exclusion Criteria:

  • Patients known to be allergic to Hirudoid or any ingredients of Hirudoid
  • Patients with impaired skin integrity caused by lesion or soft tissue trauma
  • Patients having skin lesions with ulcerations or any other severe dermatologic disease
  • Patients has been received a complete nutritional emulsion infusion within 7 days of inclusion
  • Patients with severe uncontrolled medical conditions, which makes it undesirable or unsafe for the patients to participate in the study, such as: Acute or chronic uncontrolled severe infections,Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction, serious uncontrolled cardiac arrhythmia or any other clinically serious cardiac disease, Uncontrolled diabetes as defined by fasting serum glucose > 1.5 x ULN; optimal glycaemic control should be achieved before starting trial therapy, Uncontrolled bleeding
  • Patients known to have coagulation disorders such as Haemophilia, Thrombocytopenia, Thrombosis, Other severe hematologic conditions like leukaemia, especially with abnormal coagulation
  • Patients who have symptoms of microangiopathy (small vessel disease) or neuropathy related to diabetes and other diseases
  • Patients with hyperthyroidism and hypothyroidism
  • Patients who are pregnant or breast feeding
  • Patients who are on anticoagulant therapy (last 2 weeks)
  • Patients with severe psychiatric conditions
  • Patients who are unable to bear legal responsibility or unable to understand the study
  • Patients who are unreliable or unable to comply with the protocol, like alcohol or drug abusers
  • Patients who had been participated in another clinical trial in the past 12 weeks
  • Patient is relatives of, or staff directly reporting to, the investigator
  • Patient is employee of the sponsor
  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: NCT01943006

Contacts
Contact: Tun Myint Win, MD +66 8 1847 5696 tun.myint.win@dksh.com
Contact: Philipp Grob, PhD +41792910960 grob.philipp@medinova.ch

Locations
Thailand
Siriraj Hospital Not yet recruiting
Bangkok, Thailand, 107000
Contact: Varut Loshiriwat, MD    +66 892 165 298      
Principal Investigator: Varut Lohsiriwat, MD         
General Police Hospital Not yet recruiting
Bangkok, Thailand
Contact: Nathapong Khulasittijinda, MD       khulsittijinda1@yahoo.com   
Principal Investigator: Nathapong Khulasittijinda, MD         
Rajvithi Hospital Not yet recruiting
Bangkok, Thailand
Contact: Santi Lokecharoenlarb, MD    +66 89 119 9190      
Principal Investigator: Santi Lokecharoenlarb, MD         
Chulalongkorn Hospital Not yet recruiting
Bangkok, Thailand
Contact: Boonchoo Sirichindakul, MD    +66 2 256 4117      
Principal Investigator: Boonchoo Sirichindakul, MD         
Sponsors and Collaborators
Medinova AG
  More Information

No publications provided

Responsible Party: Medinova AG
ClinicalTrials.gov Identifier: NCT01943006     History of Changes
Other Study ID Numbers: Hir-901113
Study First Received: September 6, 2013
Last Updated: May 15, 2014
Health Authority: Thailand: Food and Drug Administration

Keywords provided by Medinova AG:
Mucopolysaccaride polysulfate (MPS)
MPS
Heparinoide
Infusionphlebitis
Prevention
Superficial thrombophlebitis
Treatment

Additional relevant MeSH terms:
Phlebitis
Thrombophlebitis
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Vasculitis
Venous Thrombosis
Thrombosis
Embolism and Thrombosis

ClinicalTrials.gov processed this record on August 26, 2014