E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Adjunct to anesthesia to facilitate tracheal intubation (non-depolarizing neuromuscular blocking agent) |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine the dose-response relationship of Gantacurium Chloride for Injection on tracheal intubation conditions at 60 seconds after administration of a singe rapid bolus i.v. dose as a component of a propofol/opioid induction-intubation sequence. |
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E.2.2 | Secondary objectives of the trial |
1. To describe the tracheal intubation conditions at 60 seconds after administration of study drug with those produced by succinylcholine and placebo; 2. To describe the cardiovascular and general safety profile of a range of single rapid bolus i.v. doses of study drug in surgical patients; 3. To compare the safety profile of study drug with those of succinylcholine and placebo; 4. To determine the minimum effective dose of study drug that provides acceptable intubating conditions in ≥85% of subjects; 5. To determine the dose-response relationship of study drug on tracheal intubation at 60 seconds after administration of a single rapid bolus i.v. dose.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
A patient will be eligible for inclusion in this study only if all of the following criteria are met: 1. Male or female between 18 and 65 years of age scheduled for low- or moderate-risk surgical procedure requiring tracheal intubation 2. 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 3. ASA Physical Status Classification 1 or 2 ( refer to Appendix C) 4. Weight within 30% of ideal body weight (refer to Appendix D) 5. 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 6. In good physical and mental health as determined by the following procedures/evaluations (completed within 14 days prior to the Induction Phase [scheduled surgical procedure]): • A complete medical history • A complete physical examination • A standard 12-lead ECG and rhythm strip • Measurement of vital signs, including BP (supine), HR/pulse (supine), respiration rate and temperature • Urinalysis and clinical laboratory tests (in accordance with local practice for preoperative assessment) [Note: The investigator may assess eligibility for the study based on the results of laboratory tests on blood and urine samples taken for routine pre-operative assessment up to 2 weeks prior to the Induction Phase of the study and analyzed at a local laboratory] |
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E.4 | Principal exclusion criteria |
A patient will not be eligible for inclusion in this study if any of the following criteria are met: 1. Evidence of clinically significant cardiovascular, neuromuscular, neurological, psychiatric, renal, hepatic or pulmonary disease (including asthma), or impairment of function (as judged by the investigator) 2. Personal or family history of unusual sensitivity to NMBs or other agents used in surgical anesthesia 3. Anatomical characteristics recognized as being associated with difficult intubation conditions, even in the presence of complete jaw and vocal cord relaxation 4. History or evidence of vocal cord polyps and/or paralysis 5. History or evidence of narrow angle glaucoma 6. Personal or family history of malignant hyperthermia 7. History of major thermal injury that required hospitalization 8. Presence of genetically determined disorders of plasma cholinesterase, as determined by medical history 9. History or current evidence of abuse of any drug substance, licit or illicit (including alcohol) 10. 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. 11. 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. 12. Exposure to monoamine oxidase inhibitors within 14 days prior to the Induction Phase of the study. 13. Exposure to anticholinesterase or cholinomimetic agents within 30 days prior to the Induction Phase 14. 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 15. Pregnant (positive pregnancy test during Screening) or breastfeeding/donating breast milk 16. 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
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) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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6-24 hours after discontinuation of anesthesia for the last subject |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 4 |