A Study Comparing the Local Tolerability of Two Subcutaneous Heparins in Healthy Volunteers.
Condition: Injection Site Reaction
MeSH terms: Injection Site Reaction
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      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.
    

Intervention name(s): Sodium chloride
Intervention type(s): Drug
Intervention description(s): All participants received a single dose of sodium chloride as placebo
Other intervention name(s): Saline 0.4mL saline
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: This study was planned to be a replicated 3x3 Latin square design (5 replicates), each enrolled and randomised participant should have received a single sequence of subcutaneous injections of Placebo, Fraxiparine and Clexane, in randomised order, on three separate occasions.
Masking: Double (Participant, Investigator)
Primary purpose: Other