- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00609466
A Trial to Evaluate CG5503 Efficacy and Safety in Acute Pain After Bunionectomy
A Randomized, Double-blind, Parallel-group, Multi-center, Active- and Placebo-controlled Trial to Evaluate the Analgesic Efficacy and Safety of Multiple Doses of CG5503 IR for Postoperative Pain Following Bunionectomy
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Maryland
-
Pasadena, Maryland, United States, 21122
- Site 104
-
-
Texas
-
Austin, Texas, United States, 78705
- Site 101
-
Houston, Texas, United States, 77081
- Site 102
-
San Antonio, Texas, United States, 78229
- Site 105
-
San Marcos, Texas, United States, 78666
- Site 103
-
-
Utah
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Salt Lake City, Utah, United States, 84117
- Site 106
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
CG5503 IR 75mg 4 to 6 hourly for 72 hours
|
75mg IR 4 - 6 hourly Total: 72 hours
|
Active Comparator: 2
Morphine IR 30 mg 4 to 6 hourly for 72 hours
|
Morphine 30 mg IR 4 - 6 hourly Total: 72 hours
|
Placebo Comparator: 3
Matching placebo 4 to 6 hourly for 72 hours
|
Placebo; 4 - 6 hourly; Total: 72 hours
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sum of Pain Intensity Differences Relative to the Baseline Pain Intensity.
Time Frame: Baseline value to 48 hours after first study drug intake.
|
Pain Intensity assessed at predefined time points over a 48 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates "no pain" and a score of ten indicates "pain as bad as you can imagine".
Differences calculated as [baseline-post baseline] at each predefined time point.
The theoretical maximum range of Sum of pain intensity differences (SPID48) is from -480 (indicative of an increase in pain) to 480 (indicative of a decrease in pain).
|
Baseline value to 48 hours after first study drug intake.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Using Rescue Medication
Time Frame: Baseline up to 72 hours after first study drug intake
|
Number of participants who used at least one dose of rescue medication during the 72 hour double blind period.
|
Baseline up to 72 hours after first study drug intake
|
Total Pain Relief (TOTPAR)
Time Frame: Baseline to 48 hours after first study drug intake
|
Total pain relief (TOTPAR) in the 48 hour period from the first dose of study drug.
The subject was to indicate pain relief at rest in response to the following question: How much relief have you had from your starting pain?
None = 0, A little = 1, Some = 2, A lot = 3 and Complete = 4.
The theoretical maximum range of Total pain relief (TOTPAR)48 is from 0 (indicative of no pain relief) to 192.
The higher the value the better the pain relief.
|
Baseline to 48 hours after first study drug intake
|
Sum of Pain Intensity Differences Over 6 Hours (SPID6) Relative to the Baseline Pain Intensity
Time Frame: Baseline to 6 hours after intake of first study drug
|
Pain Intensity assessed at predefined time points over a 6 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates "no pain" and a score of ten indicates "pain as bad as you can imagine".
Differences calculated as [baseline-post baseline] at each predefined time point.
The theoretical maximum range of Sum of pain intensity differences (SPID6) is from -60 (indicative of an increase in pain) to 60 (indicative of a decrease in pain).
|
Baseline to 6 hours after intake of first study drug
|
Sum of Pain Intensity Differences Over 12 Hours (SPID12) Relative to the Baseline Pain Intensity
Time Frame: Baseline to 12 hours after first study drug intake
|
Pain Intensity assessed at predefined time points over a 12 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates "no pain" and a score of ten indicates "pain as bad as you can imagine".
Differences calculated as [baseline-post baseline] at each predefined time point.
The theoretical maximum range of Sum of pain intensity differences (SPID12) is from -120 (indicative of an increase in pain) to 120 (indicative of a decrease in pain).
|
Baseline to 12 hours after first study drug intake
|
Sum of Pain Intensity Differences Over 24 Hours (SPID24) Relative to the Baseline Pain Intensity
Time Frame: Baseline to 24 hours after first study drug intake
|
Pain Intensity assessed at predefined time points over a 24 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates "no pain" and a score of ten indicates "pain as bad as you can imagine".
Differences calculated as [baseline-post baseline] at each predefined time point.
The theoretical maximum range of Sum of pain intensity differences (SPID24) is from -240 (indicative of an increase in pain) to 240 (indicative of a decrease in pain).
|
Baseline to 24 hours after first study drug intake
|
Sum of Pain Intensity Differences Over 72 Hours (SPID72) Relative to the Baseline Pain Intensity
Time Frame: Baseline to 72 hours after first intake of study drug
|
Pain Intensity assessed at predefined time points over a 72 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates "no pain" and a score of ten indicates "pain as bad as you can imagine".
Differences calculated as [baseline-post baseline] at each predefined time point.
The theoretical maximum range of Sum of pain intensity differences (SPID72) is from -720 (indicative of an increase in pain) to 720 (indicative of a decrease in pain).
|
Baseline to 72 hours after first intake of study drug
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Stephen E Daniels, DO, Premier Research Group (formerly SCIREX Corporation)
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 574139
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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