ThrombophlebitisPhase 3NCT01943006
Efficacy and Tolerability of Hirudoid Cream in Prophylaxis and Treatment Infusion Phlebitis
A Phase 3 study testing Hirudoid cream 0.3 % Mucopolysaccharide polysulfate in people with Thrombophlebitis and Phlebitis, run by Medinova AG at 4 sites in Thailand.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Thrombophlebitis, Phlebitis
- What is being tested?
- Hirudoid cream 0.3 % Mucopolysaccharide polysulfate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 4 sitesThailand
- Study dates
- May 2015to Mar 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
4 sites in 1 country.
Thailand4 sites
Siriraj Hospital
Bangkok, 107000
Chulalongkorn Hospital
Bangkok
Rajvithi Hospital
Bangkok
Bamrasnaradua Infectious Diseases Institute
Nonthaburi
About this study
Official title: Efficacy and Tolerability of Hirudoid Cream in Prophylaxis and Treatment of Superficial Infusion Thrombophlebitis
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.
- Conditions
- Thrombophlebitis, Phlebitis
- Being tested
- Hirudoid cream 0.3 % Mucopolysaccharide polysulfate, Placebo cream without active substance
- Keywords
- Mucopolysaccaride polysulfate (MPS), MPS, Heparinoide, Infusionphlebitis, Prevention, Superficial thrombophlebitis, Treatment
- Medical subject headings
- Thrombophlebitis, Phlebitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hirudoid cream 0.3 % Mucopolysaccharide polysulfateDrug
Hirudoid cream
Placebo cream without active substanceDrug
| Study group | Role | What they receive |
|---|---|---|
| Hirudoid cream | Experimental | Patient treated with Hirudoid cream 0.3% Mucopolysaccharide polysulfate
Twice daily Receives: Drug: Hirudoid cream 0.3 % Mucopolysaccharide polysulfate |
| Placebo | Placebo comparator | Patients treated with placebo cream without active substance
Twice daily Receives: Drug: Placebo cream without active substance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patient developing superficial thrombophlebitis
Measured: 7 days
Secondary outcomes (7)
Time to develop infusion related superficial thrombophlebitis
Measured: 7 days
Change of clinical symptoms in patients who developed superficial thrombophlebitis
Pain score (10-point visual analogue score) Extent of erythema
Measured: 14 days
Time to complete resolution of signs and symptoms in patients who developed superficial thrombophlebitis
Measured: 14 days
Investigators' satisfaction
4-point rating scale
Measured: 14 days
Patient' satisfaction
4-point rating scale
Measured: 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
Measured: 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
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2013 (estimated)
- Study startMay 2015
- Primary completionFeb 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombophlebitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medinova AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01943006
- Sponsor's protocol ID
- Hir-901113
- Status last verified
- Dec 2017
- First submitted
- 6 Sep 2013
- Last updated
- 14 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerability of Hirudoid Cream in Prophylaxis and Treatment of Superficial Infusion Thrombophlebitis
- ClinicalTrials.gov ID
- NCT01943006
- Acronym / sponsor ID
- Hir-901113
- Conditions
- Thrombophlebitis, Phlebitis
- Keywords
- Mucopolysaccaride polysulfate (MPS), MPS, Heparinoide, Infusionphlebitis, Prevention, Superficial thrombophlebitis, Treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Medinova AGIndustry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Feb 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 16 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hirudoid cream | Experimental | Drug: Hirudoid cream 0.3 % Mucopolysaccharide polysulfatePatient treated with Hirudoid cream 0.3% Mucopolysaccharide polysulfate Twice daily |
| Placebo | Placebo comparator | Drug: Placebo cream without active substancePatients treated with placebo cream without active substance Twice daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hirudoid cream 0.3 % Mucopolysaccharide polysulfateHirudoid cream | Drug | Hirudoid cream |
| Placebo cream without active substance | Drug | Placebo |
Primary outcome
Number of patient developing superficial thrombophlebitis
Time frame: 7 days
7 secondary outcomes
Time to develop infusion related superficial thrombophlebitis
Time frame: 7 days
Change of clinical symptoms in patients who developed superficial thrombophlebitis
Time frame: 14 days
Time to complete resolution of signs and symptoms in patients who developed superficial thrombophlebitis
Time frame: 14 days
Investigators' satisfaction
Time frame: 14 days
Patient' satisfaction
Time frame: 14 days
Number of adverse events
Time frame: 14 days
Global tolerability
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hirudoid cream 0.3 % Mucopolysaccharide polysulfate in people with Thrombophlebitis and Phlebitis, run by Medinova AG at 4 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patient developing superficial thrombophlebitis (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2017.