HealthyPhase 1/2NCT00235976
The Efficacy and Safety of Gantacurium Chloride for Injection in Tracheal Intubation in Healthy Adult Patients Undergoing Surgery Under General Anesthesia
A Phase 1/2 study testing Gantacurium Chloride for Injection (AV430A) in people with Healthy, run by Avera Pharmaceuticals at 1 site in Germany.
Trial summary
This is a multicenter, randomized, controlled, observer-blinded, dose-response study to evaluate the efficacy in tracheal intubation and safety of gantacurium chloride for injection in healthy adult patients undergoing surgery with general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Healthy
- What is being tested?
- Gantacurium Chloride for Injection (AV430A)
- Type of treatment
- Injection or infusion
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- May 2005to Mar 2006
- Phase
- Phase 1/2
- 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 65 years
- All sexes
- Adult, Older adult
Who may be able to join
- Males or females between 18 and 65 years of age scheduled for low- or moderate-risk surgical procedure requiring tracheal intubation
- Female patients must not be of child-bearing potential. Females must meet one of the following criteria:
- Be postmenopausal;
- Have undergone prior tubal ligation or hysterectomy; or
- Be scheduled for hysterectomy as the surgical procedure for this study.
- American Society of Anesthesiologists (ASA) Physical Status Classification 1 or 2
Show all 9Show fewer
- Weight within 30% of ideal body weight
- Able to read and to comprehend information about the study design and procedure; willingness to participate in this study as evidenced by a signed and dated written Informed Consent form
- In good physical and mental health as determined by the procedures/evaluations (completed within 14 days prior to the Induction Phase [scheduled surgical procedure])
Who cannot join
- A patient will not be eligible for inclusion in this study if any of the following criteria are met:
- Evidence of clinically significant cardiovascular, neuromuscular, neurological, psychiatric, renal, hepatic or pulmonary disease (including asthma), or impairment of function (as judged by the investigator)
- Personal or family history of unusual sensitivity to NMBs or other agents used in surgical anesthesia
- Anatomical characteristics recognized as being associated with difficult intubation conditions, even in the presence of complete jaw and vocal cord relaxation
- History or evidence of vocal cord polyps and/or paralysis
- History or evidence of narrow angle glaucoma
Show all 17Show fewer
- Personal or family history of malignant hyperthermia
- History of major thermal injury that required hospitalization
- Presence of genetically determined disorders of plasma cholinesterase, as determined by medical history
- History or current evidence of abuse of any drug substance, licit or illicit (including alcohol)
- Exposure to any of the following agents within 48 hours prior to the Induction Phase of the study, or, if expected to be administered within the first 15 minutes after administration of study treatment: antibiotics (except penicillins, cephalosporins, and tetracyclines), i.v. lidocaine (except i.v. lidocaine administered in conjunction with propofol to reduce local irritation), quinidine, trimetaphan, or dexamethasone.
- Exposure to any of the following agents within 7 days prior to the Induction Phase of the study: tricyclic antidepressants, phenothiazines, anticonvulsants, antihistamines (H1 - or H2 - receptor antagonists), antihypertensives, antiarrhythmics (including procainamide), beta blockers (including propranolol, calcium channel blockers), diuretics (including furosemide, thiazides, mannitol, and acetazolamide), potent narcotics (including, but not limited to, oxycodone, methadone, morphine, buprenorphine, hydromorphone), and magnesium or lithium salts. Note: weak opioids including, but not limited to, propoxyphene, tramadol, hydrocodone, codeine, meperidine, and tilidine are not reasons for exclusion provided no changes in daily dosage have occurred within 3 days prior to the Induction Phase of the study.
- Exposure to monoamine oxidase inhibitors within 14 days prior to the Induction Phase of the study.
- Exposure to anticholinesterase or cholinomimetic agents within 30 days prior to the Induction Phase
- Previous entry into this or any other study of gantacurium chloride for injection, or participation in any other investigational drug, biologic, or medical device study within 30 days prior to the Induction Phase
- Pregnant (positive pregnancy test during Screening) or breastfeeding/donating breast milk
- Any other condition that, in the opinion of the investigator, would jeopardize the safety or rights of a subject participating in the trial or would render the subject unable to comply with the protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Controlled, Observer-Blinded, Dose-Response Study to Evaluate the Efficacy in Tracheal Intubation and Safety of Gantacurium Chloride for Injection in Healthy Adult Patients Undergoing Surgery With General Anesthesia
This is a multicenter, randomized, controlled, observer-blinded, dose-response study to evaluate the efficacy in tracheal intubation and safety of gantacurium chloride for injection in healthy adult patients undergoing surgery with general anesthesia.
Gantacurium chloride for injection (previously referred to as AV430A) is a new, investigational non-depolarizing ultra-short acting neuromuscular blocking agent (NMB). Preliminary results in animals and healthy human subjects (Phase 1 studies in adult volunteers) suggest that gantacurium chloride for injection may provide a useful adjunct to general anesthesia by permitting rapid intubation. This Phase 2 study will provide more definitive information on the ultra-short acting profile of the compound by determining the quality of intubation in patients, at 60 seconds, as assessed by a blinded intubator. In addition, the safety of the compound will be assessed. In this study, the efficacy and safety of gantacurium chloride for injection will also be compared to a reference drug, succinylcholine, and to placebo.
The primary objective of this study is to determine the dose-response relationship of gantacurium chloride for injection on tracheal intubation conditions after a single rapid bolus intravenous (i.v.) dose as a component of a propofol/opioid induction-intubation sequence and to assess the safety profile of this compound.
- Conditions
- Healthy
- Being tested
- Gantacurium Chloride for Injection (AV430A)
- Keywords
- Neuromuscular Blocking Agent, Anesthesia, Succinylcholine, Tracheal Intubation, Adjunct for tracheal intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gantacurium Chloride for Injection (AV430A)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint in this study is the graded intubation scores at 60 seconds after administration of single rapid i.v. bolus doses of study treatments (gantacurium chloride for injection, succinylcholine, or placebo)
Secondary outcomes (6)
Graded intubation scores at 120 seconds after administration of single rapid i.v. bolus doses of study treatments for those patients in whom the first intubation attempt at 60 seconds failed
Blood pressure (BP) and heart rate (HR) measurements beginning with a propofol/opioid induction-intubation sequence and ending 10 minutes after the initial intubation attempt
12-lead electrocardiograph (ECG) measurements
Number and frequency of adverse events (AEs)
Clinical laboratory data
Vital sign measurements
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study startMay 2005
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Avera Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Manfred Blobner, MD, Principal investigator, Technischen Universitat MunchenJorgen Viby-Mogensen, MD, Principal investigator, Academic Department of Anasthesia and Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00235976
- Sponsor's protocol ID
- MR/EUM202
- Status last verified
- Jul 2006
- First submitted
- 7 Oct 2005
- Last updated
- 21 Jul 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Controlled, Observer-Blinded, Dose-Response Study to Evaluate the Efficacy in Tracheal Intubation and Safety of Gantacurium Chloride for Injection in Healthy Adult Patients Undergoing Surgery With General Anesthesia
- ClinicalTrials.gov ID
- NCT00235976
- Acronym / sponsor ID
- MR/EUM202
- Conditions
- Healthy
- Keywords
- Neuromuscular Blocking Agent, Anesthesia, Succinylcholine, Tracheal Intubation, Adjunct for tracheal intubation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- Avera PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Study completion
- Mar 2006
- First posted
- 12 Oct 2005 (estimated)
- 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.
This is a multicenter, randomized, controlled, observer-blinded, dose-response study to evaluate the efficacy in tracheal intubation and safety of gantacurium chloride for injection in healthy adult patients undergoing surgery with general anesthesia.
Gantacurium chloride for injection (previously referred to as AV430A) is a new, investigational non-depolarizing ultra-short acting neuromuscular blocking agent (NMB). Preliminary results in animals and healthy human subjects (Phase 1 studies in adult volunteers) suggest that gantacurium chloride for injection may provide a useful adjunct to general anesthesia by permitting rapid intubation. This Phase 2 study will provide more definitive information on the ultra-short acting profile of the compound by determining the quality of intubation in patients, at 60 seconds, as assessed by a blinded intubator. In addition, the safety of the compound will be assessed. In this study, the efficacy and safety of gantacurium chloride for injection will also be compared to a reference drug, succinylcholine, and to placebo.
The primary objective of this study is to determine the dose-response relationship of gantacurium chloride for injection on tracheal intubation conditions after a single rapid bolus intravenous (i.v.) dose as a component of a propofol/opioid induction-intubation sequence and to assess the safety profile of this compound.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Males or females between 18 and 65 years of age scheduled for low- or moderate-risk surgical procedure requiring tracheal intubation
- Female patients must not be of child-bearing potential. Females must meet one of the following criteria:
- American Society of Anesthesiologists (ASA) Physical Status Classification 1 or 2
- Weight within 30% of ideal body weight
- Able to read and to comprehend information about the study design and procedure; willingness to participate in this study as evidenced by a signed and dated written Informed Consent form
Key exclusion criteria (17 listed)
- A patient will not be eligible for inclusion in this study if any of the following criteria are met:
- Evidence of clinically significant cardiovascular, neuromuscular, neurological, psychiatric, renal, hepatic or pulmonary disease (including asthma), or impairment of function (as judged by the investigator)
- Personal or family history of unusual sensitivity to NMBs or other agents used in surgical anesthesia
- Anatomical characteristics recognized as being associated with difficult intubation conditions, even in the presence of complete jaw and vocal cord relaxation
- History or evidence of vocal cord polyps and/or paralysis
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 |
|---|---|---|
| Gantacurium Chloride for Injection (AV430A) | Drug | – |
Primary outcome
The primary endpoint in this study is the graded intubation scores at 60 seconds after administration of single rapid i.v. bolus doses of study treatments (gantacurium chloride for injection, succinylcholine, or placebo)
6 secondary outcomes
Graded intubation scores at 120 seconds after administration of single rapid i.v. bolus doses of study treatments for those patients in whom the first intubation attempt at 60 seconds failed
Blood pressure (BP) and heart rate (HR) measurements beginning with a propofol/opioid induction-intubation sequence and ending 10 minutes after the initial intubation attempt
12-lead electrocardiograph (ECG) measurements
Number and frequency of adverse events (AEs)
Clinical laboratory data
Vital sign measurements
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 21 Jul 2006.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Manfred Blobner, MD principal investigator
Technischen Universitat Munchen
Jorgen Viby-Mogensen, MD principal investigator
Academic Department of Anasthesia and Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Gantacurium Chloride for Injection (AV430A) in people with Healthy, run by Avera Pharmaceuticals at 1 site in Germany.
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 9 inclusion and 17 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 21 Jul 2006. 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 Germany. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The primary endpoint in this study is the graded intubation scores at 60 seconds after administration of single rapid i.v. bolus doses of study treatments (gantacurium chloride for injection, succinylcholine, or placebo). 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 21 Jul 2006.