A Phase 3 interventional study of Hirudoid cream 0.3 % Mucopolysaccharide polysulfate and Placebo cream without active substance in Thrombophlebitis and Phlebitis, sponsored by Medinova AG. Completed at 4 sites in Thailand. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-12-14.
Sponsored by Medinova AG · Phase 3, Interventional, and Prevention
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.
15 studies on the registry are indexed under Thrombophlebitis; 2 are open to participants now.
This study's enrollment of 144 is above the median of 104 across 11 interventional studies indexed under Thrombophlebitis.
Browse Thrombophlebitis studies →Medinova AG is the lead sponsor of 6 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patient treated with Hirudoid cream 0.3% Mucopolysaccharide polysulfate Twice daily
Drug: Hirudoid cream 0.3 % Mucopolysaccharide polysulfate
Patients treated with placebo cream without active substance Twice daily
Drug: Placebo cream without active substance
Hirudoid cream
Number of patient developing superficial thrombophlebitis
Time frame: 7 days
Time to develop infusion related superficial thrombophlebitis
Time frame: 7 days
Change of clinical symptoms in patients who developed superficial thrombophlebitis
Pain score (10-point visual analogue score) Extent of erythema
Time frame: 14 days
Time to complete resolution of signs and symptoms in patients who developed superficial thrombophlebitis
Time frame: 14 days
Investigators' satisfaction
4-point rating scale
Time frame: 14 days
Patient' satisfaction
4-point rating scale
Time frame: 14 days
Number of adverse events
Number of any adverse events and adverse drug reactions including their severity experienced by the patients during the course of therapy
Time frame: 14 days
Global tolerability
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
Time frame: 14 days
Fasting blood glucose (FBS)
Laboratory test performed on day 1 and at the end of the study
Time frame: 14 days
Platelet, red blood cell and leukocyte count
Laboratory testing is performed on day 1 and end of study
Time frame: 14 days
Alanine transaminase (ALT),
Laboratory testing is performed on day 1 and end of study
Time frame: 14 days
Aspartate transaminase (AST),
Laboratory testing is performed on day 1 and end of study
Time frame: 14 days
Fibrinogen and activated partial thromboplastin time (aPTT)
Laboratory testing is performed on day 1 and end of study
Time frame: 14 days
Prothrombin time (PT)
Laboratory testing is performed on day 1 and end of study
Time frame: 14 days
Serum creatinine
Laboratory testing is performed on day 1 and end of study
Time frame: 14 days
This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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Medinova AG