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

NCT03841396 | Completed Phase 4

• 1 other identifier: CSA-15-ASP-002
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Injection Site Reaction

Outcome Measures

Primary Outcomes (2)

• 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

  Over a period of 30 minutes

• 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

  Over a period of 30 minutes

Secondary Outcomes (2)

• Quantification of local injection site reaction

  10 and 30 minutes and 1, 2 and 3 days after the injection.

• Pain duration

  1, 3, 5, 10, 15 and 30 minutes after administration of IP.

Study Arms (2)

Fraxiparine

ACTIVE COMPARATOR

Nadroparine, Pre-filled syringe, 3800IU, single dose

Drug: Sodium chloride

Clexane

ACTIVE COMPARATOR

Enoxaparin, Pre-filled syringe, 40 mg, single dose

Drug: Sodium chloride

Interventions

Sodium chloride DRUG

All participants received a single dose of sodium chloride as placebo

Also known as: Saline 0.4mL saline

Clexane; Fraxiparine

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aspen Global Incorporated: lead

MeSH Terms

Conditions

Injection Site Reaction

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Extravasation of Diagnostic and Therapeutic Materials; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: February 15, 2019
• Study Start: June 2, 2016
• Primary Completion: July 15, 2016
• Study Completion: July 15, 2016
• Last Updated: February 15, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share