Back to resultsA Study Comparing the Local Tolerability of Two Subcutaneous Heparins in Healthy Volunteers.
Primary Purpose
Injection Site Reaction
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Sodium chloride
Sponsored by
About this trial
This is an interventional other trial for Injection Site Reaction
Eligibility Criteria
Inclusion Criteria:
- Male or Female participant.
- Aged 18 years to 55 years.
- Medically healthy participants.
- Weight Females: ≥ 45 kg; Males ≥ 57 kg.
- Body Mass Index (BMI) of 18,5 to 29,9 kg/m2.
- 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.
- 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:
- A known hypersensitivity to Clexane or Fraxiparine or any components thereof - especially allergies to latex, pork products, sulfites and benzyl alcohols.
- Female participants who are pregnant or lactating.
- Any coagulopathy - Anaemia, thrombocytopenia, hemophilia, haemorrhagic diathesis (Bleeding, Bruising, Clotting disorders).
- Active gastric or duodenal ulcer or history of previous gastric duodenal bleeding or gastrointestinal bleeding.
- 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.
- A Cerebrovascular incident (hemorrhagic or ischemic).
- Deep Vein Thrombosis and/ Pulmonary embolism.
- Acute infective endocarditis or history of acute endocarditis.
- Participants with Hypertension.
- Diabetics.
- Any injuries or surgery of the ears, eyes, brain or spinal cord within the last 18 months.
- Renal insufficiency (Creatinine and Urea not within normal ranges).
- Hepatic Insufficiency ( aspartate aminotransferase (AST) and alanine transaminase (ALT) within normal ranges).
- Participants with Heamorrhagic Retinopathy.
- Participants with prosthetic heart valve/s.
- Participants currently receiving any other treatments administered via subcutaneous or intramuscular routes.
- Participants with a history or current endocrine, pulmonary, cardiovascular, gastrointestinal, neurological, immunological, renal, hepatic, dermatologic, haematologic, psychiatric disease other than specified that might have/cause unwanted effects/outcomes in this clinical trial.
- Alcohol and/ or drug abuse in the past year.
- In the opinion of the investigator, the participant is not reliable to participate in the trial.
Participants that have taken part in a clinical trial involving Clexane and/ Fraxiparine.
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Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Fraxiparine
Clexane
Arm Description
Nadroparine, Pre-filled syringe, 3800IU, single dose
Enoxaparin, Pre-filled syringe, 40 mg, single dose
Outcomes
Primary Outcome Measures
Comparison of Visual Analog Scale (VAS) scores of pain intensity at injection site following a single subcutaneous injection of placebo, Fraxiparine or Clexane
Visual Analogue Scales for pain intensity was performed at different time points namely 1, 3, 5, 10, 15 and 30 minutes after administration of the investigational product (IP) at Visit 2, 3 and 4. Pain intensity: 0 mm - No pain; 100 mm - Worst pain
Comparison of Numeric Rating Scale (NRS) scores of pain intensity at injection site following a single subcutaneous injection of placebo, Fraxiparine or Clexane.
11-point NRS for pain intensity was performed at different time points namely 1, 3, 5, 10, 15 and 30 minutes after administration of the investigational product (IP) at Visit 2, 3 and 4. Pain intensity: 0 - No pain; 10 - Worst pain
Secondary Outcome Measures
Quantification of local injection site reaction
Hematoma, erythema and oedema were measured 10 and 30 minutes and 1, 2 and 3 days after the injection, using transparent millimetric measuring paper.
Pain duration
Duration of pain at injection site.
Full Information
NCT ID
NCT03841396
First Posted
January 29, 2019
Last Updated
February 13, 2019
Sponsor
Aspen Global Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT03841396
Brief Title
A Study Comparing the Local Tolerability of Two Subcutaneous Heparins in Healthy Volunteers.
Official Title
A Phase IV, Randomised, Double-blind Study Comparing the Local Tolerability of Two Subcutaneous Heparins, Fraxiparine and Clexane, in Healthy Volunteers.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
June 2, 2016 (Actual)
Primary Completion Date
July 15, 2016 (Actual)
Study Completion Date
July 15, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aspen Global Incorporated
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Injection Site Reaction
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
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
ParticipantInvestigator
Masking Description
This was a double blind study and it was conducted under double blind conditions. The study medications, as well as the placebo, were contained in pre-packaged syringes which are different in physical appearance. Therefore to ensure double blinding conditions, the study medications (Fraxiparine, Clexane and Placebo) were packaged in an identical boxes and labelled identically (apart from the treatment number). To further ensure that the participants remained blinded during the study, a blindfold was put over the eyes of each participant at each visit that required IP administration.
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fraxiparine
Arm Type
Active Comparator
Arm Description
Nadroparine, Pre-filled syringe, 3800IU, single dose
Arm Title
Clexane
Arm Type
Active Comparator
Arm Description
Enoxaparin, Pre-filled syringe, 40 mg, single dose
Intervention Type
Drug
Intervention Name(s)
Sodium chloride
Other Intervention Name(s)
Saline 0.4mL saline
Intervention Description
All participants received a single dose of sodium chloride as placebo
Primary Outcome Measure Information:
Title
Comparison of Visual Analog Scale (VAS) scores of pain intensity at injection site following a single subcutaneous injection of placebo, Fraxiparine or Clexane
Description
Visual Analogue Scales for pain intensity was performed at different time points namely 1, 3, 5, 10, 15 and 30 minutes after administration of the investigational product (IP) at Visit 2, 3 and 4. Pain intensity: 0 mm - No pain; 100 mm - Worst pain
Time Frame
Over a period of 30 minutes
Title
Comparison of Numeric Rating Scale (NRS) scores of pain intensity at injection site following a single subcutaneous injection of placebo, Fraxiparine or Clexane.
Description
11-point NRS for pain intensity was performed at different time points namely 1, 3, 5, 10, 15 and 30 minutes after administration of the investigational product (IP) at Visit 2, 3 and 4. Pain intensity: 0 - No pain; 10 - Worst pain
Time Frame
Over a period of 30 minutes
Secondary Outcome Measure Information:
Title
Quantification of local injection site reaction
Description
Hematoma, erythema and oedema were measured 10 and 30 minutes and 1, 2 and 3 days after the injection, using transparent millimetric measuring paper.
Time Frame
10 and 30 minutes and 1, 2 and 3 days after the injection.
Title
Pain duration
Description
Duration of pain at injection site.
Time Frame
1, 3, 5, 10, 15 and 30 minutes after administration of IP.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male or Female participant.
Aged 18 years to 55 years.
Medically healthy participants.
Weight Females: ≥ 45 kg; Males ≥ 57 kg.
Body Mass Index (BMI) of 18,5 to 29,9 kg/m2.
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.
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:
A known hypersensitivity to Clexane or Fraxiparine or any components thereof - especially allergies to latex, pork products, sulfites and benzyl alcohols.
Female participants who are pregnant or lactating.
Any coagulopathy - Anaemia, thrombocytopenia, hemophilia, haemorrhagic diathesis (Bleeding, Bruising, Clotting disorders).
Active gastric or duodenal ulcer or history of previous gastric duodenal bleeding or gastrointestinal bleeding.
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.
A Cerebrovascular incident (hemorrhagic or ischemic).
Deep Vein Thrombosis and/ Pulmonary embolism.
Acute infective endocarditis or history of acute endocarditis.
Participants with Hypertension.
Diabetics.
Any injuries or surgery of the ears, eyes, brain or spinal cord within the last 18 months.
Renal insufficiency (Creatinine and Urea not within normal ranges).
Hepatic Insufficiency ( aspartate aminotransferase (AST) and alanine transaminase (ALT) within normal ranges).
Participants with Heamorrhagic Retinopathy.
Participants with prosthetic heart valve/s.
Participants currently receiving any other treatments administered via subcutaneous or intramuscular routes.
Participants with a history or current endocrine, pulmonary, cardiovascular, gastrointestinal, neurological, immunological, renal, hepatic, dermatologic, haematologic, psychiatric disease other than specified that might have/cause unwanted effects/outcomes in this clinical trial.
Alcohol and/ or drug abuse in the past year.
In the opinion of the investigator, the participant is not reliable to participate in the trial.
Participants that have taken part in a clinical trial involving Clexane and/ Fraxiparine.
-
12. IPD Sharing Statement
Plan to Share IPD
No
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A Study Comparing the Local Tolerability of Two Subcutaneous Heparins in Healthy Volunteers.
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