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| Name | Class |
|---|---|
| Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | INDUSTRY |
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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.
Subjects undergoing bunionectomy often experience moderate to severe acute pain post-surgery. Normally such pain is controlled when subjects receive repeated doses of opioid analgesics. However, opioid therapy is commonly associated with side effects such as nausea, vomiting, sedation, constipation, addiction, tolerance, and respiratory depression. CG5503, a newly synthesized drug with an immediate release (IR) formulation, also acts as a centrally acting pain reliever but has a dual mode of action. The aim of this trial is to investigate the effectiveness (level of pain control) and safety (side effects) of CG5503 IR 75mg compared with no drug (placebo) or one dose of morphine (an opioid commonly used to treat post-surgical pain). This trial is a randomized, double-blind (neither investigator nor patient will know which treatment was received), active- and placebo-controlled, parallel-group, multicenter trial to evaluate the treatment of acute pain after bunionectomy. The trial will include a blinded 72 hour inpatient phase immediately following bunionectomy, during which subjects will be treated with either 75-mg CG5503 IR, a placebo, or 30-mg morphine, and pain relief will be periodically assessed. Assessments of pain relief include the pain intensity numeric rating scale (PI), pain relief numeric rating scale (PAR), and patient global impression of change scale (PGIC). Safety evaluations include monitoring of adverse events, physical examinations, and clinical laboratory tests. Venous blood samples will be collected for the determination of serum concentrations of CG5503 and morphine. The alternative trial hypothesis is that at least 1 dose strength of CG5503 will be different from placebo in controlling pain at 48 hours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | CG5503 IR 75mg 4 to 6 hourly for 72 hours |
|
| 2 | Active Comparator | Morphine IR 30 mg 4 to 6 hourly for 72 hours |
|
| 3 | Placebo Comparator | Matching placebo 4 to 6 hourly for 72 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CG5503 IR | Drug | 75mg IR 4 - 6 hourly Total: 72 hours |
| |
| Morphine |
| Measure | Description | Time Frame |
|---|---|---|
| Sum of Pain Intensity Differences Relative to the Baseline Pain Intensity. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Using Rescue Medication | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen E Daniels, DO | Premier Research Group (formerly SCIREX Corporation) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 104 | Pasadena | Maryland | 21122 | United States | ||
| Site 101 |
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).
The recruitment period for this in-patient, multicenter study occurred between 04 September 2007 and 11 December 2007.
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| ID | Title | Description |
|---|---|---|
| FG000 | CG5503 | CG5503 IR 75mg 4-6 hourly |
| FG001 | Morphine | Morphine IR 30mg 4 to 6 hourly |
| FG002 | Placebo | Matching Placebo 4 to 6 hourly |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CG5503 | CG5503 IR 75mg 4-6 hourly |
| BG001 | Morphine | Morphine IR 30mg 4 to 6 hourly |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sum of Pain Intensity Differences Relative to the Baseline Pain Intensity. | 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). | Intention to Treat - randomized subjects who were dosed and had a baseline pain intensity assessment. Last observation carried forward was used. | Posted | Mean | Standard Deviation | units | Baseline value to 48 hours after first study drug intake. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CG5503 | CG5503 IR 75mg 4-6 hourly |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stevens Johnson Syndrome | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 10.1 | Non-systematic Assessment |
Lortab (hydrocodone/acetaminophen) was allowed as rescue medication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| René Allard | Grunenthal | 49 241 569 3223 | Clinical-Trials@grunenthal.com |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D010149 | Pain, Postoperative |
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
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| ID | Term |
|---|---|
| D009020 | Morphine |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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| Drug |
Morphine 30 mg IR 4 - 6 hourly Total: 72 hours |
|
| Placebo | Drug | Placebo; 4 - 6 hourly; Total: 72 hours |
|
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 | 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 | 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 | 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 | 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 |
| Austin |
| Texas |
| 78705 |
| United States |
| Site 102 | Houston | Texas | 77081 | United States |
| Site 105 | San Antonio | Texas | 78229 | United States |
| Site 103 | San Marcos | Texas | 78666 | United States |
| Site 106 | Salt Lake City | Utah | 84117 | United States |
| Lack of Efficacy |
|
| BG002 |
| Placebo |
Matching Placebo 4 to 6 hourly |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Morphine | Morphine IR 30mg 4 to 6 hourly |
| OG002 | Placebo | Matching Placebo 4 to 6 hourly |
|
|
|
| Secondary | Number of Participants Using Rescue Medication | Number of participants who used at least one dose of rescue medication during the 72 hour double blind period. | Intention to treat (ITT) and Last Observation Carried Forward (LOCF) | Posted | Number | participants | Baseline up to 72 hours after first study drug intake |
|
|
|
|
| Secondary | Total Pain Relief (TOTPAR) | 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. | Intention to treat(ITT)and Last Observation Carried Forward (LOCF) | Posted | Mean | Standard Deviation | units | Baseline to 48 hours after first study drug intake |
|
|
|
|
| Secondary | Sum of Pain Intensity Differences Over 6 Hours (SPID6) Relative to the Baseline Pain Intensity | 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). | Intention to treat(ITT) and Last Observation Carried Forward (LOCF). | Posted | Mean | Standard Deviation | units | Baseline to 6 hours after intake of first study drug |
|
|
|
|
| Secondary | Sum of Pain Intensity Differences Over 12 Hours (SPID12) Relative to the Baseline Pain Intensity | 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). | Intention to treat (ITT) and Last Observation Carried Forward (LOCF). | Posted | Mean | Standard Deviation | units | Baseline to 12 hours after first study drug intake |
|
|
|
|
| Secondary | Sum of Pain Intensity Differences Over 24 Hours (SPID24) Relative to the Baseline Pain Intensity | 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). | Intention to treat (ITT)and Last Observation Carried Forward (LOCF). | Posted | Mean | Standard Deviation | units | Baseline to 24 hours after first study drug intake |
|
|
|
|
| Secondary | Sum of Pain Intensity Differences Over 72 Hours (SPID72) Relative to the Baseline Pain Intensity | 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). | Intention to treat (ITT) and Last Observation Carried Forward (LOCF). | Posted | Mean | Standard Deviation | units | Baseline to 72 hours after first intake of study drug |
|
|
|
|
| 0 |
| 69 |
| EG001 | Morphine | Morphine IR 30mg 4 to 6 hourly | 1 | 85 |
| EG002 | Placebo | Matching Placebo 4 to 6 hourly | 0 | 47 |
| Vomiting | Gastrointestinal disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Gamma glutamyl transferase increased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 10.1 | Non-systematic Assessment |
|
Grünenthal GmbH reserves the right to review any publication pertaining to the trial before it is submitted for publication. Neither Grünenthal nor the investigator has the right to prohibit publication unless publication can be shown to affect possible patent rights.
| D010335 | Pathologic Processes |
| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |