A Trial to Evaluate CG5503 Efficacy and Safety in Acute Pain After Bunionectomy
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00609466 |
Recruitment Status :
Completed
First Posted : February 7, 2008
Results First Posted : November 25, 2009
Last Update Posted : November 16, 2011
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Bunionectomy Pain Postoperative Pain Acute Pain | Drug: CG5503 IR Drug: Morphine Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 291 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | September 2007 |
Actual Primary Completion Date : | February 2008 |
Actual Study Completion Date : | February 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
CG5503 IR 75mg 4 to 6 hourly for 72 hours
|
Drug: CG5503 IR
75mg IR 4 - 6 hourly Total: 72 hours |
Active Comparator: 2
Morphine IR 30 mg 4 to 6 hourly for 72 hours
|
Drug: Morphine
Morphine 30 mg IR 4 - 6 hourly Total: 72 hours |
Placebo Comparator: 3
Matching placebo 4 to 6 hourly for 72 hours
|
Drug: Placebo
Placebo; 4 - 6 hourly; Total: 72 hours |
- 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).
- 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.
- 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.
- 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).
- 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).
- 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).
- 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).

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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;

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00609466
United States, Maryland | |
Site 104 | |
Pasadena, Maryland, United States, 21122 | |
United States, Texas | |
Site 101 | |
Austin, Texas, United States, 78705 | |
Site 102 | |
Houston, Texas, United States, 77081 | |
Site 105 | |
San Antonio, Texas, United States, 78229 | |
Site 103 | |
San Marcos, Texas, United States, 78666 | |
United States, Utah | |
Site 106 | |
Salt Lake City, Utah, United States, 84117 |
Principal Investigator: | Stephen E Daniels, DO | Premier Research Group (formerly SCIREX Corporation) |
Responsible Party: | Grünenthal GmbH |
ClinicalTrials.gov Identifier: | NCT00609466 |
Other Study ID Numbers: |
574139 |
First Posted: | February 7, 2008 Key Record Dates |
Results First Posted: | November 25, 2009 |
Last Update Posted: | November 16, 2011 |
Last Verified: | November 2011 |
Opioid Central acting analgesic CG5503 IR Postoperative pain |
Bunionectomy Morphine Placebo |
Pain, Postoperative Acute Pain Postoperative Complications Pathologic Processes Pain Neurologic Manifestations Morphine |
Analgesics, Opioid Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents |