Pain following bunionectomy MedDRA version: 6.0 Level: LLT Classification code 10006586
Conditions
Sponsors
SkyePharma, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the appropriate dose of SKY0402 administered as a nerve block for the management of post-operative pain following a bunionectomy.;Secondary Objective: 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.;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. | — |
Countries
United Kingdom
Outcome results
None listed