E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated | Pain following bunionectomy | |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.0 | E.1.2 | Level | LLT | E.1.2 | Classification code | 10006586 | |
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 appropriate dose of SKY0402 administered as a nerve block for the management of post-operative pain following a bunionectomy. | |
E.2.2 | Secondary objectives of the trial | To evaluate the safety, efficacy, and pharmacokinetics of various doses of SKY0402 (starting at 175 mg and increasing/decreasing in an incremental fashion, with the dose not to exceed 350 mg) compared to a single 125 mg dose of unencapsulated bupivacaine. | |
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria | 1. Males and females* greater than or equal to 18 years of age. *Note: Eligible females must be post-menopausal or surgically sterile, or, if of childbearing potential, they must not be pregnant or nursing, and they must agree not to become pregnant during the study by using acceptable means of contraception for at least one month before and one month after dosing, including any of the following: hormonal contraceptives (oral, injectable, implantable), effective barrier methods (e.g. condoms with spermicide), intrauterine device (IUD), lifestyle with a personal choice of abstinence, non-hetrosexual lifestyle, or in a strictly monogamous relationship with a partner who has had a vasectomy. 2. Scheduled to undergo a primary unilateral first metatarsal bunionectomy repair** under general anesthesia with or without internal fixation. ** Note: For the purpose of this protocol, all surgical procedures involving osteotomy of the first metatarsal (significant bone resection, excision, surgical fracture, etc.) or fusion of the first metatarsal-phalangeal joints are considered qualified procedures, whether or not performed specifically to repair a bunion (hallus valgus deformity). Surgical techniques accompanied by minimal bone excision (e.g. Cheilectomy) or procedures limited to soft tissue repair are NOT eligible for this study. 3. ASA Physical Class 1 or 2 4. Able and willing to comply with all study visits and procedures 5. Capable of speaking and understanding the local language sufficiently to provide responses to pain assessment scales 6. Willing and capable of providing written informed consent | |
E.4 | Principal exclusion criteria | 1. Clinically significant ECG abnormalities at Screening or on Day 1 (pre-dose) 2. Albumin and/or alpha 1-acid glycoprotein below normal levels 3. Current or historical evidence of any clinically significant disease or condition that, in the opinion of the Investigator, might increase the risk of surgery or complicate the subject's post-operative course 4. Opioid medication usage during the 7-day period preceeding the administration of the study drug 5. Current medical conditions that could require treatment with analgesic medications in the post-operative period for pain that is not surgically related (e.g. rheumatoid arthritis) 6. Body mass index greater than 30 7. Body weight less than 60 kilograms 8. History of hypersensitivity or idiosyncratic reaction to amide-type local anaesthetic agents 9. History of hypersensitivity or idiosyncratic reactions to the pain control agents (opioid or non opioid) anticipated to be used post-operatively. These contraindications may include: angioedema and bronchospastic reactivity to NSAID, peptic ulcer (active within the last three months), hepatic or renal insufficiency. 10. Coagulation disorders or ongoing anticoagulation treatment 11 Administration of an investigational drug within 30 days or 5 half lives prior to the study 12. Suspected or known history of substance abuse and/or alcoholism | |
E.5 End points |
E.5.1 | Primary end point(s) | Efficacy: Time to first use of supplemental pain medication (opioid or non-opioid) post-operatively for surgical wound pain. Safety: Vital signs, ECG, routine laboratory tests, AEs, Injection site evaluation. | |
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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
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 | No |
E.8.1.4 | Double blind | Yes |
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 | No |
E.8.2.3 | Other | No |
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 | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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 | The last visit of the last subject undergoing the trial. | |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |