Status:
COMPLETED
A Trial to Evaluate CG5503 Efficacy and Safety in Acute Pain After Bunionectomy
Lead Sponsor:
Grünenthal GmbH
Collaborating Sponsors:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Bunionectomy
Pain
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
The main objective of this trial is to demonstrate the efficacy and safety of multiple-dose application of oral application of CG5503 IR 75mg compared to placebo and to assess safety and tolerability ...
Detailed Description
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, opioi...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
291 Patients enrolled
Trial Details
Trial ID
NCT00609466
Start Date
September 1 2007
End Date
February 1 2008
Last Update
November 16 2011
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Site 104
Pasadena, Maryland, United States, 21122
2
Site 101
Austin, Texas, United States, 78705
3
Site 102
Houston, Texas, United States, 77081
4
Site 105
San Antonio, Texas, United States, 78229