A Trial to Evaluate CG5503 Efficacy and Safety in Acute Pain After Bunionectomy

Launched by GRÜNENTHAL GMBH · Jan 24, 2008

Keywords

ClinConnect Summary

Subjects undergoing bunionectomy often experience moderate to severe acute pain post-surgery. Normally such pain is controlled when subjects receive repeated doses of opioid analgesics. However, opioid therapy is commonly associated with side effects such as nausea, vomiting, sedation, constipation, addiction, tolerance, and respiratory depression. CG5503, a newly synthesized drug with an immediate release (IR) formulation, also acts as a centrally acting pain reliever but has a dual mode of action. The aim of this trial is to investigate the effectiveness (level of pain control) and safety...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male and female subjects between 18 and 80 years of age;
• • Scheduled to undergo primary unilateral first metatarsal bunionectomy;
• • Anesthesiological and surgical procedures performed according to protocol;
• • Moderate or severe baseline pain following bunionectomy on a VRS within 9 hours of termination of the continuous popliteal sciatic block or systemic analgesia;
• • Pain following bunionectomy of at least 4 on an 11-point NRS within 9 hours of termination of the continuous popliteal sciatic block or systemic analgesia; American Society of Anesthesiologists (ASA) classification I-III.
• Exclusion Criteria:
• • History of seizure disorder;
• • History of alcohol, medication or drug dependency, unstable psychological personality requiring intermittent or permanent treatment; severely impaired renal function, moderately or severely impaired hepatic function;
• • Contraindications to, or history of allergy or hypersensitivity to CG5503, oxycodone, morphine, fentanyl hydrocodone, acetaminophen, heparin, or any compound planned to be used during the anesthesia, or their excipients;
• • Pre-operative use within 12h prior to surgery or peri-operative use of non- steroidal anti-inflammatory drugs (NSAIDs);
• • Treated regularly with opioid analgesic or NSAIDs within 30 days prior to screening;