A Phase 2, Multicenter, Randomized, Double-Blind, Dose-Escalating/De-Escalating Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of a Single Dose of Sustained-Release Encapsulated Bupivacaine (SKY0402) in the Management of Post-Operative Pain in Subjects Undergoing Inguinal Hernia Repair - N/A

Phase 1

• Conditions: Pain following inguinal hernia repair; MedDRA version: 6.0Level: LLTClassification code 10022020

• Registration Number: EUCTR2004-002342-35-GB
• Lead Sponsor: SkyePharma, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-02-23
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 88

Inclusion Criteria

1. Males greater than or equal to 18 years of age
2. Scheduled to undergo a unilateral inguinal hernia repair under general anesthesia, using an open, tension free procedure (e.g. Lichenstein technique with or without mesh
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

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 kg
8. History of hypersensitivity or idiosyncratic reaction to amide-type local anaesthetic agents
9. History of hypersensitivity reaction 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 3 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): Efficacy: Time to first use of supplemental pain medication (opioid or non-opioid) post-operatively for wound healing.<br><br>Safety: Vital signs, 12-lead ECG, physical examination, routine laboratory tests, AEs and SAEs, wound healing evaluation.;Main Objective: To determine the appropriate dose of SKY0402 for the management of post-operative pain following inguinal hernia repair.;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 100 mg dose of unencapsulated bupivacaine.