AnesthesiaPhase 1NCT03399435
A Study in Healthy Male Volunteers to Investigate the Safety and Tolerability of a Single Dose of Neosaxitoxin Alone and in Combination With Bupivacaine (With and Without Epinephrine) for Brachial Plexus Blockade
A Phase 1 study testing Neosaxitoxin combined with bupivacaine low and epinephrine (T1), Bupivacaine low combined with epinephrine (C1) and Bupivacaine high combined with epinephrine (C2) in people with Anesthesia and Anesthesia, Local, run by Grünenthal GmbH at 1 site in Netherlands.
Trial summary
Neosaxitoxin is a new compound that is in clinical development as local anesthetic for surgical anesthesia and postoperative analgesia. The primary objective of this study is to evaluate the systemic and local safety and tolerability of ascending doses of neosaxitoxin alone and in combination with fixed doses of… Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Anesthesia, Local, Analgesia
- What is being tested?
- Neosaxitoxin combined with bupivacaine low and epinephrine (T1), Bupivacaine low combined with epinephrine (C1) and Bupivacaine high combined with epinephrine (C2)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 1 siteNetherlands
- Study dates
- 30 Jan 2018to 21 Sep 2018
- Phase
- Phase 1
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject has given written informed consent to participate.
- Male subject, aged 18 years to 55 years, inclusive.
- Body mass index between 20.0 kg/m2 and 30.0 kg/m2 inclusive, with a minimal body weight of 60.0 kg.
- Subject must be in good health as determined by the prior/concomitant diseases, physical and laboratory examinations.
- Subject must be willing not to donate sperm and to use barrier contraception (condom) during sexual intercourse with women from the administration of IMP until Day 90 since IMP administration. The subject must be willing to ensure that the female sexual partner of childbearing potential uses at least 1 additional method of contraception with a low failure rate defined as <1% per year (e.g., oral contraceptives) during this time frame. A single barrier method alone is not acceptable.
Who cannot join
- At enrollment:
- Resting pulse rate <50 beats or >90 beats per minute.
- Resting systolic blood pressure <90 mmHg or >140 mmHg. Resting diastolic blood pressure >90 mmHg.
- Prolongation of QTcF at enrollment, i.e., QTcF >450 ms, or presence of any other of risk factors for torsade de pointes or other disturbances of cardiac de- and repolarization.
- Any out-of-reference range value for the following safety laboratory parameters: GGT, serum creatinine, PT, and INR.
- Any exclusion range met for urinalysis and the following safety laboratory parameters: ALT, AST, ALP, total bilirubin, glucose, LDH, potassium, total protein, sodium, calcium, CK, hemoglobin, hematocrit, white blood cell count, and platelets.
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- Any out-of-reference range value for any other safety laboratory parameter that is judged as clinically relevant by the investigator.
- Positive or missing virus serology test for HIV Type 1 or Type 2 antibodies and antigen, hepatitis B surface antigen, hepatitis B core antibodies, or hepatitis C virus antibodies.
- Subject received IMP in another clinical trial within 1 month before the Enrollment Visit. Depending on the nature of the previous IMP, a longer washout may be needed.
- Diseases or conditions known to interfere with the distribution, metabolism, or excretion of drugs.
- History of orthostatic hypotension.
- History of, or at risk of seizures.
- Significant cardiovascular, respiratory, neuromuscular diseases, or other systemic illness.
- Subject with an oxygen saturation of less than 95%, as measured by pulse oximetry, or subject with known or suspected respiratory difficulty or any condition that may compromise a subject's breathing or ability to maintain adequate oxygen saturation.
- Known vocal chord palsy.
- Any relevant symptom of neurological dysfunction of the motor and sensory system based on sensory and motor function testing. History or presence of symptoms of depression or anxiety disorders.
- Previous injury or surgery of the involved shoulder in the last 2 years.
- Any relevant local abnormality at the targeted area of injection.
- Any acute or chronic pain condition requiring ongoing treatment or limiting daily activities.
- Definite or suspected history of drug allergy, particularly to bupivacaine or other local anesthetics, epinephrine, or clinically relevant other allergies.
- Evidence or history of alcohol or drug abuse including positive or missing drugs of abuse screen.
- Regular use of any medication, including herbal remedies or over-the counter medication within 2 weeks before enrollment into this trial and anticipated use during the course of the trial.
- Habitually smoking more than 10 cigarettes, 2 cigars, or 2 pipes of tobacco per day within the last 6 months before enrollment in this trial.
- Known or suspected of not being able to comply with the requirements of the trial protocol or the instructions of the trial site staff.
- Not able to communicate meaningfully with the trial site staff.
- Employee of the investigator or trial site, with direct involvement in the proposed trial or other trials under the direction of that investigator or trial site, as well as family members of the employees or the investigator.
- Blood loss of 500 mL or more within 3 months before enrollment in this trial.
- On Day -1:
- Any relevant deterioration in the health of the subject since the Enrollment Visit possibly impacting participation in the trial, including AEs, safety laboratory parameters, vital signs, body temperature, ECG, or other safety parameters at the discretion of the investigator.
- Out-of-reference blood pressure or pulse rate if technical failure can be excluded and result is confirmed by at least 1 additional measurement: Systolic blood pressure <90 mmHg or >140 mmHg, diastolic blood pressure >90 mmHg, pulse rate <50 beats or >90 beats per minute.
- Clinically relevant QTcF interval prolongation, i.e., QTcF interval >450 ms.
- Any out-of-reference range value for the following safety laboratory parameters: GGT, serum creatinine, PT, and INR.
- Any exclusion range met for urinalysis and the following safety laboratory parameters: ALT, AST, ALP, total bilirubin, glucose, LDH, potassium, total protein, sodium, calcium, CK, hemoglobin, hematocrit, white blood cell count, and platelets.
- Any out-of-reference range value for any other safety laboratory parameter that is judged as clinically relevant by the investigator.
- Positive or missing drugs of abuse screen.
- Intake of forbidden medication since the enrollment in this trial.
- Participation in another clinical trial since the Enrollment Visit.
- Blood loss of 100 mL or more since enrollment in this trial.
- Failure to comply with trial requirements, e.g., consumption of alcohol, etc., considered by the investigator to affect subject safety or interfere with the integrity of the trial.
- Any relevant local abnormality at the targeted area of injection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Exploratory Phase I Randomized, Single-site, Double-blind, Active-controlled, Parallel-group, Single-administration, Dose-escalation Trial to Investigate the Safety and Tolerability of Neosaxitoxin Alone and in Combination With Bupivacaine (With and Without Epinephrine), in Perineural Administrations for Brachial Plexus Blockade in Healthy Subjects
Neosaxitoxin is a new compound that is in clinical development as local anesthetic for surgical anesthesia and postoperative analgesia.
The primary objective of this study is to evaluate the systemic and local safety and tolerability of ascending doses of neosaxitoxin alone and in combination with fixed doses of bupivacaine (with and without epinephrine), following brachial plexus blockade in healthy male subjects.
Read more
Secondary objectives:
- Evaluate the pharmacodynamics (PD) of ascending doses of neosaxitoxin, alone and in combination with fixed doses of bupivacaine (with and without epinephrine), following brachial plexus blockade.
- Characterize the pharmacokinetics (PK) of neosaxitoxin and bupivacaine after brachial plexus blockade with neosaxitoxin alone or different drug combinations: neosaxitoxin and epinephrine, neosaxitoxin and bupivacaine, or neosaxitoxin and bupivacaine and epinephrine.
- Conditions
- Anesthesia, Anesthesia, Local, Analgesia
- Being tested
- Neosaxitoxin combined with bupivacaine low and epinephrine (T1), Bupivacaine low combined with epinephrine (C1), Bupivacaine high combined with epinephrine (C2), Neosaxitoxin combined with bupivacaine low (T2), Bupivacaine low (C3)
- Keywords
- Regional anesthesia, Brachial plexus blockade, Sensory and motor function testing
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neosaxitoxin combined with bupivacaine low and epinephrine (T1)Combination product
A single injection: Neosaxitoxin from 1.25 to 60 µg. Bupivacaine 40 mg. Epinephrine 100 µg.
Bupivacaine low combined with epinephrine (C1)Combination product
A single injection: Bupivacaine 40 mg. Epinephrine dose 100 µg.
Bupivacaine high combined with epinephrine (C2)Combination product
A single injection: Bupivacaine 100 mg. Epinephrine 100 µg.
Neosaxitoxin combined with bupivacaine low (T2)Combination product
A single injection: Neosaxitoxin from 1.25 to 60 μg. Bupivacaine from 10 to 80 mg.
Bupivacaine low (C3)Drug
A single injection: Bupivacaine from 10 to 80 mg.
Bupivacaine high (C4)Drug
A single injection: Bupivacaine 100 mg.
Neosaxitoxin (T3)Drug
A single injection: Neosaxitoxin will be between 1.25 and 60 µg.
Neosaxitoxin combined with epinephrine (T4)Combination product
A single injection: Neosaxitoxin will be between 1.25 and 60 μg. Epinephrine 100 µg.
Neosaxitoxin combined with bupivacaine low and epinephrineCombination product
A single injection: Neosaxitoxin will be between 1.25 to 60 µg. Bupivacaine dose based on results from Part B (10 to 80 mg). Epinephrine 100 µg.
Neosaxitoxin combined with bupivacaine lowCombination product
A single injection: Neosaxitoxin will be between 1.25 to 60 μg. Bupivacaine dose based on results from Part B (10 to 80 mg).
| Study group | Role | What they receive |
|---|---|---|
| Part A | Experimental | 8 cohorts are planned to be treated. Receives: Combination Product: Neosaxitoxin combined with bupivacaine low and epinephrine (T1); Combination Product: Bupivacaine low combined with epinephrine (C1); Combination Product: Bupivacaine high combined with epinephrine (C2) |
| Part B | Experimental | Part B will start at the earliest after 4 cohorts of Part A have been treated. Up to 8 cohorts are planned to be treated. Receives: Combination Product: Neosaxitoxin combined with bupivacaine low (T2); Drug: Bupivacaine low (C3); Drug: Bupivacaine high (C4) |
| Part C | Experimental | Part C will comprise 4 treatment groups. The neosaxitoxin dose will be the same in all 4 treatment groups. Receives: Drug: Neosaxitoxin (T3); Combination Product: Neosaxitoxin combined with epinephrine (T4); Combination Product: Neosaxitoxin combined with bupivacaine low and epinephrine; Combination Product: Neosaxitoxin combined with bupivacaine low |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of dose limiting events (DLEs) in all parts of the trial.
Measured: up to 15 days after IMP (investigational medicinal product, i.e. study drug administration)
Occurrence of other adverse events (AEs) leading to premature termination of dose escalation in Part A and Part B.
Measured: up to 15 days after IMP administration
Secondary outcomes (14)
Cold detection threshold (CDT).
Measured: Baseline, 24 and 48 hours after IMP administration
Warm detection threshold (WDT)
Measured: Baseline, 24 and 48 hours after IMP administration
Mechanical detection threshold (MDT)
Measured: Baseline, 24 and 48 hours after IMP administration
Cold pain threshold (CPT)
Measured: Baseline, 24 and 48 hours after IMP administration
Heat pain threshold (HPT)
Measured: Baseline, 24 and 48 hours after IMP administration
Mechanical pain threshold (MPT)
Measured: Baseline, 24 and 48 hours after IMP administration
Muscle grip strength (ipsilateral)
Measured: Baseline, 24 and 48 hours after IMP administration
Muscle motor function (flexion and extension elbow joint, abduction shoulder joint)
Measured: Baseline, 24 and 48 hours after IMP administration
AUC0-t of neosaxitoxin
Measured: up to 56 hours after IMP administration
AUC0-t of bupivacaine
Measured: up to 56 hours after IMP administration
Cmax of neosaxitoxin
Measured: up to 56 hours after IMP administration
Cmax of bupivacaine
Measured: up to 56 hours after IMP administration
tmax of neosaxitoxin
Measured: up to 56 hours after IMP administration
tmax of bupivacaine
Measured: up to 56 hours after IMP administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2018
- Study start30 Jan 2018
- Primary completion21 Sep 2018
- Study completion21 Sep 2018
Why it stopped: The sponsor decided to stop further dosing of healthy volunteers after reviewing the obtained efficacy data. The decision is not related to any safety concern.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Part A: 8 cohorts (equivalent to 40 subjects) are planned to be treated with ascending doses of neosaxitoxin combined with fixed doses of bupivacaine and epinephrine. Part B: Part B will start at the earliest after 4 cohorts of Part A have been treated. Ascending doses of neosaxitoxin combined with fixed doses of bupivacaine. Part C: Part C will comprise 4 treatment groups in which all participants will receive the same neosaxitoxin dose alone, or neosaxitoxin combined with epinephrine, or neosaxitoxin combined with bupivacaine with or without epinephrine.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grünenthal GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Grünenthal GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03399435
- Sponsor's protocol ID
- HP7020-02
- Other IDs
- 2016-003958-33, U1111-1189-1950, 2016
- Status last verified
- Oct 2018
- First submitted
- 8 Jan 2018
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Information available on the Grünenthal Group Web Site ( according to the EFPIA Data Sharing Principles.
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Phase I Randomized, Single-site, Double-blind, Active-controlled, Parallel-group, Single-administration, Dose-escalation Trial to Investigate the Safety and Tolerability of Neosaxitoxin Alone and in Combination With Bupivacaine (With and Without Epinephrine), in Perineural Administrations for Brachial Plexus Blockade in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03399435
- Acronym / sponsor ID
- HP7020-02
- Conditions
- Anesthesia, Anesthesia, Local, Analgesia
- Keywords
- Regional anesthesia, Brachial plexus blockade, Sensory and motor function testing
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The sponsor decided to stop further dosing of healthy volunteers after reviewing the obtained efficacy data. The decision is not related to any safety concern.
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Grünenthal GmbHIndustry (pharma, biotech, devices)
- Study start
- 30 Jan 2018 (actual)
- Primary completion
- 21 Sep 2018 (actual)
- Study completion
- 21 Sep 2018 (actual)
- First posted
- 16 Jan 2018 (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.
Neosaxitoxin is a new compound that is in clinical development as local anesthetic for surgical anesthesia and postoperative analgesia.
The primary objective of this study is to evaluate the systemic and local safety and tolerability of ascending doses of neosaxitoxin alone and in combination with fixed doses of bupivacaine (with and without epinephrine), following brachial plexus blockade in healthy male subjects.
Secondary objectives:
- Evaluate the pharmacodynamics (PD) of ascending doses of neosaxitoxin, alone and in combination with fixed doses of bupivacaine (with and without epinephrine), following brachial plexus blockade.
- Characterize the pharmacokinetics (PK) of neosaxitoxin and bupivacaine after brachial plexus blockade with neosaxitoxin alone or different drug combinations: neosaxitoxin and epinephrine, neosaxitoxin and bupivacaine, or neosaxitoxin and bupivacaine and epinephrine.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Part A: 8 cohorts (equivalent to 40 subjects) are planned to be treated with ascending doses of neosaxitoxin combined with fixed doses of bupivacaine and epinephrine. Part B: Part B will start at the earliest after 4 cohorts of Part A have been treated. Ascending doses of neosaxitoxin combined with fixed doses of bupivacaine. Part C: Part C will comprise 4 treatment groups in which all participants will receive the same neosaxitoxin dose alone, or neosaxitoxin combined with epinephrine, or neosaxitoxin combined with bupivacaine with or without epinephrine.
| Arm | Type | Receives |
|---|---|---|
| Part A | Experimental | Combination Product: Neosaxitoxin combined with bupivacaine low and epinephrine (T1), Combination Product: Bupivacaine low combined with epinephrine (C1), Combination Product: Bupivacaine high combined with epinephrine (C2)8 cohorts are planned to be treated. |
| Part B | Experimental | Combination Product: Neosaxitoxin combined with bupivacaine low (T2), Drug: Bupivacaine low (C3), Drug: Bupivacaine high (C4)Part B will start at the earliest after 4 cohorts of Part A have been treated. Up to 8 cohorts are planned to be treated. |
| Part C | Experimental | Drug: Neosaxitoxin (T3), Combination Product: Neosaxitoxin combined with epinephrine (T4), Combination Product: Neosaxitoxin combined with bupivacaine low and epinephrine, Combination Product: Neosaxitoxin combined with bupivacaine lowPart C will comprise 4 treatment groups. The neosaxitoxin dose will be the same in all 4 treatment groups. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subject has given written informed consent to participate.
- Male subject, aged 18 years to 55 years, inclusive.
- Body mass index between 20.0 kg/m2 and 30.0 kg/m2 inclusive, with a minimal body weight of 60.0 kg.
- Subject must be in good health as determined by the prior/concomitant diseases, physical and laboratory examinations.
- Subject must be willing not to donate sperm and to use barrier contraception (condom) during sexual intercourse with women from the administration of IMP until Day 90 since IMP administration. The subject must be willing to ensure that the female sexual partner of childbearing potential uses at least 1 additional method of contraception with a low failure rate defined as <1% per year (e.g., oral contraceptives) during this time frame. A single barrier method alone is not acceptable.
Key exclusion criteria (40 listed)
- Resting pulse rate <50 beats or >90 beats per minute.
- Resting systolic blood pressure <90 mmHg or >140 mmHg. Resting diastolic blood pressure >90 mmHg.
- Prolongation of QTcF at enrollment, i.e., QTcF >450 ms, or presence of any other of risk factors for torsade de pointes or other disturbances of cardiac de- and repolarization.
- Any out-of-reference range value for the following safety laboratory parameters: GGT, serum creatinine, PT, and INR.
- Any exclusion range met for urinalysis and the following safety laboratory parameters: ALT, AST, ALP, total bilirubin, glucose, LDH, potassium, total protein, sodium, calcium, CK, hemoglobin, hematocrit, white blood cell count, and platelets.
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 |
|---|---|---|
| Neosaxitoxin combined with bupivacaine low and epinephrine (T1)A single injection: Neosaxitoxin from 1.25 to 60 µg. Bupivacaine 40 mg. Epinephrine 100 µg. | Combination product | Part A |
| Bupivacaine low combined with epinephrine (C1)A single injection: Bupivacaine 40 mg. Epinephrine dose 100 µg. | Combination product | Part A |
| Bupivacaine high combined with epinephrine (C2)A single injection: Bupivacaine 100 mg. Epinephrine 100 µg. | Combination product | Part A |
| Neosaxitoxin combined with bupivacaine low (T2)A single injection: Neosaxitoxin from 1.25 to 60 μg. Bupivacaine from 10 to 80 mg. | Combination product | Part B |
| Bupivacaine low (C3)A single injection: Bupivacaine from 10 to 80 mg. | Drug | Part B |
| Bupivacaine high (C4)A single injection: Bupivacaine 100 mg. | Drug | Part B |
| Neosaxitoxin (T3)A single injection: Neosaxitoxin will be between 1.25 and 60 µg. | Drug | Part C |
| Neosaxitoxin combined with epinephrine (T4)A single injection: Neosaxitoxin will be between 1.25 and 60 μg. Epinephrine 100 µg. | Combination product | Part C |
| Neosaxitoxin combined with bupivacaine low and epinephrineA single injection: Neosaxitoxin will be between 1.25 to 60 µg. Bupivacaine dose based on results from Part B (10 to 80 mg). Epinephrine 100 µg. | Combination product | Part C |
| Neosaxitoxin combined with bupivacaine lowA single injection: Neosaxitoxin will be between 1.25 to 60 μg. Bupivacaine dose based on results from Part B (10 to 80 mg). | Combination product | Part C |
Primary outcome
Occurrence of dose limiting events (DLEs) in all parts of the trial.
Time frame: up to 15 days after IMP (investigational medicinal product, i.e. study drug administration)
Occurrence of other adverse events (AEs) leading to premature termination of dose escalation in Part A and Part B.
Time frame: up to 15 days after IMP administration
14 secondary outcomes
Cold detection threshold (CDT).
Time frame: Baseline, 24 and 48 hours after IMP administration
Warm detection threshold (WDT)
Time frame: Baseline, 24 and 48 hours after IMP administration
Mechanical detection threshold (MDT)
Time frame: Baseline, 24 and 48 hours after IMP administration
Cold pain threshold (CPT)
Time frame: Baseline, 24 and 48 hours after IMP administration
Heat pain threshold (HPT)
Time frame: Baseline, 24 and 48 hours after IMP administration
Mechanical pain threshold (MPT)
Time frame: Baseline, 24 and 48 hours after IMP administration
Muscle grip strength (ipsilateral)
Time frame: Baseline, 24 and 48 hours after IMP administration
Muscle motor function (flexion and extension elbow joint, abduction shoulder joint)
Time frame: Baseline, 24 and 48 hours after IMP administration
AUC0-t of neosaxitoxin
Time frame: up to 56 hours after IMP administration
AUC0-t of bupivacaine
Time frame: up to 56 hours after IMP administration
Cmax of neosaxitoxin
Time frame: up to 56 hours after IMP administration
Cmax of bupivacaine
Time frame: up to 56 hours after IMP administration
tmax of neosaxitoxin
Time frame: up to 56 hours after IMP administration
tmax of bupivacaine
Time frame: up to 56 hours after IMP administration
Results and safety
The study was stopped early (reason given: The sponsor decided to stop further dosing of healthy volunteers after reviewing the obtained efficacy data. The decision is not related to any safety concern.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
- Individual participant dataSharing planned: Yes. Information available on the Grünenthal Group Web Site ( according to the EFPIA Data Sharing Principles.
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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.
Study Director study director
Grünenthal GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Neosaxitoxin combined with bupivacaine low and epinephrine (T1), Bupivacaine low combined with epinephrine (C1) and Bupivacaine high combined with epinephrine (C2) in people with Anesthesia and Anesthesia, Local, run by Grünenthal GmbH at 1 site in Netherlands.
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 5 inclusion and 40 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: stopped early, as of the sponsor's last update on 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early (reason given: The sponsor decided to stop further dosing of healthy volunteers after reviewing the obtained efficacy data. The decision is not related to any safety concern.). Results are not available in the source record.
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?
Occurrence of dose limiting events (DLEs) in all parts of the trial. (time frame: up to 15 days after IMP (investigational medicinal product, i.e. study drug administration)). 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 11 Oct 2018.