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| Study Type: | Interventional |
|---|---|
| Study Design: | Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment |
| Conditions: |
Bunionectomy Pain Postoperative Pain Acute Pain |
| Interventions: |
Drug: CG5503 IR Drug: Morphine Drug: Placebo |
Participant Flow
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| The recruitment period for this in-patient, multicenter study occurred between 04 September 2007 and 11 December 2007. |
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| The trial consisted of a Screening Period (Day -28 up to the first surgical incision on Day -1), a Surgical Period (Day -1 to Day 1 at approximately 03:00 h.), a Qualification Period (Day 1), a Double-Blind Treatment Period (Day 1 up to Day 4), and a Follow-up Period (Day 8 up to Day 18). |
| Description | |
|---|---|
| CG5503 | CG5503 IR 75mg 4-6 hourly |
| Morphine | Morphine IR 30mg 4 to 6 hourly |
| Placebo | Matching Placebo 4 to 6 hourly |
| CG5503 | Morphine | Placebo | |
|---|---|---|---|
| STARTED | 96 | 96 | 99 |
| COMPLETED | 94 | 90 | 95 |
| NOT COMPLETED | 2 | 6 | 4 |
| Withdrawal by Subject | 0 | 1 | 1 |
| Adverse Event | 2 | 3 | 1 |
| Lack of Efficacy | 0 | 2 | 2 |
Baseline Characteristics
| Description | |
|---|---|
| CG5503 | CG5503 IR 75mg 4-6 hourly |
| Morphine | Morphine IR 30mg 4 to 6 hourly |
| Placebo | Matching Placebo 4 to 6 hourly |
| CG5503 | Morphine | Placebo | Total | |
|---|---|---|---|---|
|
Number of Participants [units: participants] |
96 | 96 | 99 | 291 |
|
Age [units: participants] |
||||
| <=18 years | 0 | 1 | 1 | 2 |
| Between 18 and 65 years | 94 | 88 | 90 | 272 |
| >=65 years | 2 | 7 | 8 | 17 |
|
Age [units: years] Mean ± Standard Deviation |
44.6 ± 12.58 | 43.7 ± 14.19 | 43.8 ± 13.93 | 44.0 ± 13.55 |
|
Gender [units: participants] |
||||
| Female | 83 | 73 | 88 | 244 |
| Male | 13 | 23 | 11 | 47 |
|
Region of Enrollment [units: participants] |
||||
| United States | 96 | 96 | 99 | 291 |
Outcome Measures
| 1. Primary: | Sum of Pain Intensity Differences Relative to the Baseline Pain Intensity. [ Baseline value to 48 hours after first study drug intake. ] |
| 2. Secondary: | Number of Participants Using Rescue Medication [ Baseline up to 72 hours after first study drug intake ] |
| 3. Secondary: | Total Pain Relief (TOTPAR) [ Baseline to 48 hours after first study drug intake ] |
| 4. Secondary: | Sum of Pain Intensity Differences Over 6 Hours (SPID6) Relative to the Baseline Pain Intensity [ Baseline to 6 hours after intake of first study drug ] |
| 5. Secondary: | Sum of Pain Intensity Differences Over 12 Hours (SPID12) Relative to the Baseline Pain Intensity [ Baseline to 12 hours after first study drug intake ] |
| 6. Secondary: | Sum of Pain Intensity Differences Over 24 Hours (SPID24) Relative to the Baseline Pain Intensity [ Baseline to 24 hours after first study drug intake ] |
| 7. Secondary: | Sum of Pain Intensity Differences Over 72 Hours (SPID72) Relative to the Baseline Pain Intensity [ Baseline to 72 hours after first intake of study drug ] |
More Information
| Principal Investigators are NOT employed by the organization sponsoring the study. | ||||||
| There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. | ||||||
The agreement is:
|
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| Lortab (hydrocodone/acetaminophen) was allowed as rescue medication. |
| Responsible Party: | Grünenthal GmbH ( Grünenthal GmbH ) |
| Study ID Numbers: | 574139 |
| Study First Received: | January 24, 2008 |
| Results First Received: | September 16, 2009 |
| Last Updated: | October 22, 2009 |
| ClinicalTrials.gov Identifier: | NCT00609466 History of Changes |
| Health Authority: | United States: Food and Drug Administration |