NCT03841396

A Study Comparing the Local Tolerability of Two Subcutaneous Heparins in Healthy Volunteers.

A Phase IV, Randomised, Double-blind Study Comparing the Local Tolerability of Two Subcutaneous Heparins, Fraxiparine and Clexane, in Healthy Volunteers.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Aspen Global Incorporated · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Injection Site Reaction

Interventions

Type	Name	Description
DRUG	Sodium chloride	All participants received a single dose of sodium chloride as placebo

Timeline

• Start date: 2016-06-02
• Primary completion: 2016-07-15
• Completion: 2016-07-15
• First posted: 2019-02-15
• Last updated: 2019-02-15