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The purpose of this study is to determine whether Indomethacin [Test] Capsules are safe and effective for the treatment of postoperative bunionectomy pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Indomethacin 40 mg TID | Experimental |
| |
| Indomethacin 40 mg BID | Experimental |
| |
| Indomethacin 20 mg TID | Experimental |
| |
| Celecoxib 200 mg | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indomethacin | Drug | 40 mg TID capsules |
| |
| Indomethacin |
| Measure | Description | Time Frame |
|---|---|---|
| The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale From 0 to 48 Hours After Trial Entry (VASSPID-48) | The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing "No Pain" and 100 mm representing "Worst Possible Pain". The VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment. | 0 - 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| VASSPID-4. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 4 Hours After Trial Entry. | The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing "No Pain" and 100 mm representing "Worst Possible Pain". The VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francis Clark, DPM | Premier Research Group Limited | Principal Investigator |
| Michael Golf, DPM | Premier Research Group Limited | Principal Investigator |
| Ira Gottlieb, DPM | Chesapeake Research Group, LLC | Principal Investigator |
| Kyle Patrick, DO | Premier Research Group Limited | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Premier Research Group Limited | Phoenix | Arizona | 85027 | United States | ||
| Chesapeake Research Group, LLC |
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| ID | Title | Description |
|---|---|---|
| FG000 | Indomethacin 40 mg TID | Indomethacin : 40 mg TID capsules |
| FG001 | Indomethacin 40 mg BID | Indomethacin : 40 mg BID capsules |
| FG002 | Indomethacin 20 mg TID | Indomethacin : 20 mg TID capsules |
| FG003 | Celecoxib 200 mg | Celecoxib : 200 mg capsules |
| FG004 | Placebo | Placebo : Capsules |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Celecoxib 200 mg | Celecoxib : 200 mg capsules |
| BG001 | Indomethacin 20 mg TID | Indomethacin : 20 mg TID capsules |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale From 0 to 48 Hours After Trial Entry (VASSPID-48) | The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing "No Pain" and 100 mm representing "Worst Possible Pain". The VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment. | Intent to Treat Population | Posted | Mean | Standard Deviation | mm*hour | 0 - 48 hours |
|
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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 | Celecoxib 200 mg | Celecoxib : 200 mg capsules |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deep vein thrombosis | Vascular disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Solorio | Iroko Pharmaceuticals, LLC | 267-546-3150 | dsolorio@iroko.com |
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| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D000068579 | Celecoxib |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
40 mg BID capsules |
|
| Indomethacin | Drug | 20 mg TID capsules |
|
| Celecoxib | Drug | 200 mg capsules |
|
| Placebo | Drug | Capsules |
|
| 0 - 4 hours |
| VASSPID-8. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 8 Hours After Trial Entry. | The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing "No Pain" and 100 mm representing "Worst Possible Pain". The VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment. | 0 - 8 hours |
| VASSPID-24. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 24 Hours After Trial Entry | The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing "No Pain" and 100 mm representing "Worst Possible Pain". The VAS summed pain intensity difference (VASSPID) is calculated as a time-weighted sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment. | 0 - 24 hours |
| Total Pain Relief (TOTPAR) Over 0 to 4 Hours (TOTPAR-4). | Pain relief was assessed using a 5-point categorical scale at all assessment time points after time 0. Subjects were asked "How much relief have you had since your starting pain?" with response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4. The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. In this way individual scores covering a longer time period were given more weight. The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 16 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0. | 0 - 4 hours |
| TOTPAR-8. Total Pain Relief (TOTPAR) Over 0 to 8 Hours | Pain relief was assessed using a 5-point categorical scale at all assessment time points after time 0. Subjects were asked "How much relief have you had since your starting pain?" with response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4. The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. In this way individual scores covering a longer time period were given more weight. The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 32 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0. | 0 - 8 hours |
| TOTPAR-24. Total Pain Relief (TOTPAR) Over 0 to 24 Hours | Pain relief was assessed using a 5-point categorical scale at all assessment time points after time 0. Subjects were asked "How much relief have you had since your starting pain?" with response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4. The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. In this way individual scores covering a longer time period were given more weight. The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 96 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0. | 0 - 24 hours |
| TOTPAR-48. Total Pain Relief (TOTPAR) Over 0 to 48 Hours | Pain relief was assessed using a 5-point categorical scale at all assessment time points after time 0. Subjects were asked "How much relief have you had since your starting pain?" with response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4. The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. In this way individual scores covering a longer time period were given more weight. The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 192 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0. | 0 - 48 hours |
| Pasadena |
| Maryland |
| 21122 |
| United States |
| Premier Research Group Limited | Austin | Texas | 78705 | United States |
| Premier Research Group Limited | Salt Lake City | Utah | 84107 | United States |
| Adverse Event |
|
| BG002 |
| Indomethacin 40 mg BID |
Indomethacin : 40 mg BID capsules |
| BG003 | Indomethacin 40 mg TID | Indomethacin : 40 mg TID capsules |
| BG004 | Placebo | Placebo : Capsules |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Indomethacin 40 mg BID | Indomethacin : 40 mg BID capsules |
| OG002 | Indomethacin 20 mg TID | Indomethacin : 20 mg TID capsules |
| OG003 | Celecoxib 200 mg | Celecoxib : 200 mg capsules |
| OG004 | Placebo | Placebo : Capsules |
|
|
|
| Secondary | VASSPID-4. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 4 Hours After Trial Entry. | The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing "No Pain" and 100 mm representing "Worst Possible Pain". The VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment. | Intent to Treat Population | Posted | Mean | Standard Deviation | mm*hour | 0 - 4 hours |
|
|
|
|
| Secondary | VASSPID-8. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 8 Hours After Trial Entry. | The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing "No Pain" and 100 mm representing "Worst Possible Pain". The VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment. | Intent to Treat Population | Posted | Mean | Standard Deviation | mm*hour | 0 - 8 hours |
|
|
|
|
| Secondary | VASSPID-24. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 24 Hours After Trial Entry | The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing "No Pain" and 100 mm representing "Worst Possible Pain". The VAS summed pain intensity difference (VASSPID) is calculated as a time-weighted sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment. | Intent to Treat Population | Posted | Mean | Standard Deviation | mm*hour | 0 - 24 hours |
|
|
|
|
| Secondary | Total Pain Relief (TOTPAR) Over 0 to 4 Hours (TOTPAR-4). | Pain relief was assessed using a 5-point categorical scale at all assessment time points after time 0. Subjects were asked "How much relief have you had since your starting pain?" with response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4. The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. In this way individual scores covering a longer time period were given more weight. The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 16 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0. | Intent to Treat Population | Posted | Mean | Standard Deviation | units on a scale*hour | 0 - 4 hours |
|
|
|
|
| Secondary | TOTPAR-8. Total Pain Relief (TOTPAR) Over 0 to 8 Hours | Pain relief was assessed using a 5-point categorical scale at all assessment time points after time 0. Subjects were asked "How much relief have you had since your starting pain?" with response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4. The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. In this way individual scores covering a longer time period were given more weight. The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 32 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0. | Intent to Treat Population | Posted | Mean | Standard Deviation | units on a scale*hour | 0 - 8 hours |
|
|
|
|
| Secondary | TOTPAR-24. Total Pain Relief (TOTPAR) Over 0 to 24 Hours | Pain relief was assessed using a 5-point categorical scale at all assessment time points after time 0. Subjects were asked "How much relief have you had since your starting pain?" with response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4. The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. In this way individual scores covering a longer time period were given more weight. The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 96 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0. | Intent to Treat Population | Posted | Mean | Standard Deviation | units on a scale*hour | 0 - 24 hours |
|
|
|
|
| Secondary | TOTPAR-48. Total Pain Relief (TOTPAR) Over 0 to 48 Hours | Pain relief was assessed using a 5-point categorical scale at all assessment time points after time 0. Subjects were asked "How much relief have you had since your starting pain?" with response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4. The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. In this way individual scores covering a longer time period were given more weight. The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 192 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0. | Intent to Treat Population | Posted | Mean | Standard Deviation | units on a scale*hour | 0 - 48 hours |
|
|
|
|
| 0 |
| 93 |
| 68 |
| 93 |
| EG001 | Indomethacin 20 mg TID | Indomethacin : 20 mg TID capsules | 0 | 91 | 69 | 91 |
| EG002 | Indomethacin 40 mg BID | Indomethacin : 40 mg BID capsules | 1 | 91 | 74 | 91 |
| EG003 | Indomethacin 40 mg TID | Indomethacin : 40 mg TID capsules | 0 | 93 | 66 | 93 |
| EG004 | Placebo | Placebo : Capsules | 0 | 94 | 71 | 94 |
| Dizziness | Nervous system disorders |
|
| Vomiting | Gastrointestinal disorders |
|
| Post procedural edema | Injury, poisoning and procedural complications |
|
| Headache | Nervous system disorders |
|
| Post procedural hemorrhage | Injury, poisoning and procedural complications |
|
| Erythema | Skin and subcutaneous tissue disorders |
|
| Pruritus | Skin and subcutaneous tissue disorders |
|
| Presyncope | Nervous system disorders |
|
Not provided
Not provided
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| 95 |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.211 | 95 | No | Superiority or Other |
| t-test, 2 sided | 0.098 | 95 | No | Superiority or Other |
| 95 |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.017 | 95 | No | Superiority or Other |
| t-test, 2 sided | 0.028 | 95 | No | Superiority or Other |
| 95 |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.004 | 95 | No | Superiority or Other |
| t-test, 2 sided | 0.015 | 95 | No | Superiority or Other |
| 95 |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.146 | 95 | No | Superiority or Other |
| t-test, 2 sided | 0.071 | 95 | No | Superiority or Other |
| 95 |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.010 | 95 | No | Superiority or Other |
| t-test, 2 sided | 0.016 | 95 | No | Superiority or Other |
| 95 |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.005 | 95 | No | Superiority or Other |
| t-test, 2 sided | 0.017 | 95 | No | Superiority or Other |
| 95 |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.012 | 95 | No | Superiority or Other |
| t-test, 2 sided | 0.029 | 95 | No | Superiority or Other |