A Trial to Evaluate CG5503 Efficacy and Safety in Acute Pain After Bunionectomy
Completed · Phase 3 · Has a placebo group
Conditions studied: Bunionectomy, Pain, Postoperative Pain, Acute Pain
In brief
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 of CG5503 IR 75mg in subjects following bunionectomy. This trial was performed based on a previously performed double-blind, placebo-controlled, multiple-dose trial in the same indication investigating 3 dose strengths CG5503 IR (50, 75 and 100 mg) published under PMID: 18851776.
Key facts
- Study ID
- NCT00609466
- Run by
- Grünenthal GmbH
- People needed
- 291
- Starts
- 2007-09-01
- Expected to finish
- 2008-02-01
- Last updated by the study team
- 2011-11-16
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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;
Where it is running
- Site 104 — Pasadena, Maryland, United States
- Site 101 — Austin, Texas, United States
- Site 102 — Houston, Texas, United States
- Site 105 — San Antonio, Texas, United States
- Site 103 — San Marcos, Texas, United States
- Site 106 — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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