A Study Comparing the Local Tolerability of Two Subcutaneous Heparins in Healthy Volunteers. (NCT03841396) | Clinical Trial Compass
CompletedPhase 4
A Study Comparing the Local Tolerability of Two Subcutaneous Heparins in Healthy Volunteers.
15 participantsStarted 2016-06-02
Plain-language summary
A Phase IV, Randomised, Double-blind, Single-centre clinical trial in healthy male and female participants aged 18 to 55, that was designed to assess and compare the pain intensity at an injection site as well as the duration of pain following a single dose subcutaneous administration of two low molecular weight heparins (LMWH) respectively.
Who can participate
Age range18 Years ā 55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. Male or Female participant.
ā. Aged 18 years to 55 years.
ā. Medically healthy participants.
ā. Weight Females: ā„ 45 kg; Males ā„ 57 kg.
ā. Body Mass Index (BMI) of 18,5 to 29,9 kg/m2.
ā. Female participants of child-bearing potential must have a negative urine pregnancy test at screening and be willing to use effective contraceptives throughout the trial duration.
ā. Participants must be able to understand and follow the instructions of the Investigator, understand and give informed consent, and be willing, committed, and able to return for all site visits and complete all study-related procedures.
Exclusion criteria
ā. A known hypersensitivity to Clexane or Fraxiparine or any components thereof - especially allergies to latex, pork products, sulfites and benzyl alcohols.
ā. Female participants who are pregnant or lactating.
ā. Active gastric or duodenal ulcer or history of previous gastric duodenal bleeding or gastrointestinal bleeding.
ā. Participants on the following medications: Anti-coagulants, Non-Steroidal Anti-inflammatory Drugs (NSAID)s, glycoprotein IIb/IIIa anticoagulants, thrombolytic agents, platelet-inhibitors, acetylsalicylic acid, sulfinpyrazone, quinine - containing remedies and/drinks, treprostinil, apixaban, drotecogin alfa, danshen, dong quai, evening primrose oil, gingko, policosanol and willow bark as well as hyperkalemia aggravators in the last 7 days.
What they're measuring
1
Comparison of Visual Analog Scale (VAS) scores of pain intensity at injection site following a single subcutaneous injection of placebo, Fraxiparine or Clexane
Timeframe: Over a period of 30 minutes
2
Comparison of Numeric Rating Scale (NRS) scores of pain intensity at injection site following a single subcutaneous injection of placebo, Fraxiparine or Clexane.