Phase 3
Completed N=291
A Trial to Evaluate CG5503 Efficacy and Safety in Acute Pain After Bunionectomy
Bunionectomy · Postoperative Pain
Source: ClinicalTrials.gov NCT00609466 ↗
Enrolled (actual)
291
Serious AEs
—
Results posted
Nov 2009
Primary outcomePrimary: Sum of Pain Intensity Differences Relative to the Baseline Pain Intensity. — 46.2; 102.5; -17.5 units — p=<0.0001
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 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sum of Pain Intensity Differences Relative to the Baseline Pain Intensity. |
46.2; 102.5; -17.5 | <0.0001 sig |
| SECONDARY Number of Participants Using Rescue Medication |
62; 46; 82 | <0.0001 sig |
| SECONDARY Total Pain Relief (TOTPAR) |
79.2; 81.6; 41.8 | <0.0001 sig |
| SECONDARY Sum of Pain Intensity Differences Over 6 Hours (SPID6) Relative to the Baseline Pain Intensity |
8.0; 8.0; -1.2 | <0.0001 sig |
| SECONDARY Sum of Pain Intensity Differences Over 12 Hours (SPID12) Relative to the Baseline Pain Intensity |
14.4; 17.9; -4.7 | <0.0001 sig |
| SECONDARY Sum of Pain Intensity Differences Over 24 Hours (SPID24) Relative to the Baseline Pain Intensity |
22.3; 41.3; -10.7 | <0.0001 sig |
| SECONDARY Sum of Pain Intensity Differences Over 72 Hours (SPID72) Relative to the Baseline Pain Intensity |
78.4; 174.1; -19.1 | 0.0002 sig |
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;
Data sourced from ClinicalTrials.gov (NCT00609466). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.