Injection Site Reaction Clinical Trial
Official title:
A Phase IV, Randomised, Double-blind Study Comparing the Local Tolerability of Two Subcutaneous Heparins, Fraxiparine and Clexane, in Healthy Volunteers.
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.
This was 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 LMWHs respectively. This study included an approximate
seven-day screening period (screening visit to day 0), followed by three visits (Visit 2, 3
and 4) in one-week intervals, in which each participant should have received a single
sequence of subcutaneous injections of Placebo, Fraxiparine and Clexane, in a randomised
order, on the three separate occasions. This was then followed by a safety follow-up visit,
one week after the administration of the last dose of the study product.
Fifteen (N = 15) healthy, consenting participants, fulfilling the inclusion criteria, were
randomised to take part in this study. All participants received a single sequence of
subcutaneous injections, on separate occasions at one week intervals, over the duration of
the treatment phase of the study. Fifteen (N=15) participants received Fraxiparine, fifteen
(N=15) participants received Clexane and fifteen (N=15) participants received Placebo. Two
participants were screened however did not meet the eligibility criteria and therefore were
not included into the study. Informed consent was obtained at Screening Visit 1 (day -7 to 0)
before any trial-related procedures were be performed. Visual analogue and 11-point numeric
rating scales were utilised to measure pain intensity after a single injection of
investigational product. These scales were also used to assess burning and pruritus. All
scales were be completed at set time intervals over a 30 minute period, i.e. 1, 3, 5, 10, 15
and 30 minutes after the injections were completed. Hematoma, erythema and oedema were
measured minutes and 1, 2 and 3 days after the injection, using transparent millimetric
measuring paper. Safety bloods were drawn at each visit.
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