Injection Site ReactionPhase 4NCT03841396
A Study Comparing the Local Tolerability of Two Subcutaneous Heparins in Healthy Volunteers.
A Phase 4 study testing Sodium chloride in people with Injection Site Reaction, run by Aspen Global Incorporated.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Injection Site Reaction
- What is being tested?
- Sodium chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 2 Jun 2016to 15 Jul 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
- -
About this study
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.
Read the 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
- Being tested
- Sodium chloride
- Medical subject headings
- Injection Site Reaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium chlorideDrug
Also called Saline 0.4mL saline
All participants received a single dose of sodium chloride as placebo
| Study group | Role | What they receive |
|---|---|---|
| Fraxiparine | Active comparator | Nadroparine, Pre-filled syringe, 3800IU, single dose Receives: Drug: Sodium chloride |
| Clexane | Active comparator | Enoxaparin, Pre-filled syringe, 40 mg, single dose Receives: Drug: Sodium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Over a period of 30 minutes
Secondary outcomes (2)
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.
Measured: 10 and 30 minutes and 1, 2 and 3 days after the injection.
Pain duration
Duration of pain at injection site.
Measured: 1, 3, 5, 10, 15 and 30 minutes after administration of IP.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start2 Jun 2016
- Primary completion15 Jul 2016
- Study completion15 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injection Site ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aspen Global Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03841396
- Sponsor's protocol ID
- CSA-15-ASP-002
- Status last verified
- Jan 2019
- First submitted
- 29 Jan 2019
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Randomised, Double-blind Study Comparing the Local Tolerability of Two Subcutaneous Heparins, Fraxiparine and Clexane, in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT03841396
- Acronym / sponsor ID
- CSA-15-ASP-002
- Conditions
- Injection Site Reaction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Aspen Global IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 2 Jun 2016 (actual)
- Primary completion
- 15 Jul 2016 (actual)
- Study completion
- 15 Jul 2016 (actual)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Fraxiparine | Active comparator | Drug: Sodium chlorideNadroparine, Pre-filled syringe, 3800IU, single dose |
| Clexane | Active comparator | Drug: Sodium chlorideEnoxaparin, Pre-filled syringe, 40 mg, single dose |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium chlorideAlso: Saline 0.4mL salineAll participants received a single dose of sodium chloride as placebo | Drug | Clexane, Fraxiparine |
Primary outcome
Comparison of Visual Analog Scale (VAS) scores of pain intensity at injection site following a single subcutaneous injection of placebo, Fraxiparine or Clexane
Time frame: Over a period of 30 minutes
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.
Time frame: Over a period of 30 minutes
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
2 secondary outcomes
Quantification of local injection site reaction
Time frame: 10 and 30 minutes and 1, 2 and 3 days after the injection.
Pain duration
Time frame: 1, 3, 5, 10, 15 and 30 minutes after administration of IP.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sodium chloride in people with Injection Site Reaction, run by Aspen Global Incorporated.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Visual Analog Scale (VAS) scores of pain intensity at injection site following a single subcutaneous injection of placebo, Fraxiparine or Clexane (time frame: Over a period of 30 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.