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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 |
| |
| Placebo | Placebo Comparator |
| |
| Indomethacin 20 mg TID | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indomethacin | Drug | capsules, 40 mg, TID |
| |
| 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". Pain intensity is assessed at baseline (time "0") and at the following time points after time 0: 15, 30, and 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 32, 40, and 48 hours. 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". Pain intensity is assessed at baseline (time "0") and at the following time points after time 0: 15, 30, and 45 minutes and 1, 1.5, 2, 3, and 4 hours. 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 |
|---|---|---|
| Jason Dickerson, 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 Nanoformulation Capsules 40 mg TID |
| FG001 | Indomethacin 40 mg BID | Indomethacin Nanoformulation Capsules 40 mg BID |
| FG002 | Indomethacin 20 mg TID | Indomethacin Nanoformulation Capsules 20 mg TID |
| FG003 | Placebo | Placebo Group |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Indomethacin 40 mg TID | Indomethacin Nanoformulation Capsules 40 mg TID |
| BG001 | Indomethacin 40 mg BID | Indomethacin Nanoformulation Capsules 40 mg BID |
| 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". Pain intensity is assessed at baseline (time "0") and at the following time points after time 0: 15, 30, and 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 32, 40, and 48 hours. 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. All subjects who received at least 1 dose of trial drug. | 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 | Indomethacin 40 mg TID | Indomethacin Nanoformulation Capsules 40 mg TID |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 14.0 |
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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 |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
capsules, 40 mg, BID |
|
| Indomethacin | Drug | capsules, 20 mg, TID |
|
| 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". Pain intensity is assessed at baseline (time "0") and at the following time points after time 0: 15, 30, and 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 hours. 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". Pain intensity is assessed at baseline (time "0") and at the following time points after time 0: 15, 30, and 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, and 24 hours. 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 with a 5-point categorical scale at all assessment timepoints 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. Pain relief is assessed at the following points after time 0: 15, 30 & 45 minutes and 1, 1.5, 2, 3 & 4 hours. 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. Thus, individual scores covering a longer period were given more weight. The minimum theoretical score is 0 units, which represents no pain relief (0 on scale) at all points after time 0. The maximum theoretical score is 16 units, which represents complete pain relief (4 on scale) at all points after 0. | 0-4 hours |
| TOTPAR-8. Total Pain Relief (TOTPAR) Over 0 to 8 Hours | Pain relief was assessed with a 5-point categorical scale at all assessment timepoints 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. Pain relief is assessed at the following points after time 0: 15, 30 & 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7 & 8 hours. 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. Thus, individual scores covering a longer period were given more weight. The minimum theoretical score is 0 units, which represents no pain relief (0 on scale) at all points after time 0. The maximum theoretical score is 32 units, which represents complete pain relief (4 on scale) at all points after 0. | 0-8 hours |
| TOTPAR-24. Total Pain Relief (TOTPAR) Over 0 to 24 Hours | Pain relief was assessed with a 5-point categorical scale at all assessment timepoints 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. Pain relief is assessed at the following points after time 0: 15, 30 & 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, & 24 hours. 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. Thus, individual scores covering a longer period were given more weight. The minimum theoretical score is 0 units, which represents no pain relief (0 on scale) at all points after time 0. The maximum theoretical score is 96 units, which represents complete pain relief (4 on scale) at all points after 0. | 0-24 hours |
| TOTPAR-48. Total Pain Relief (TOTPAR) Over 0 to 48 Hours | Pain relief was assessed with a 5-point categorical scale at all assessment timepoints 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. Pain relief is assessed at the following points after time 0: 15, 30 & 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 32, 40 & 48 hours. 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. Thus, individual scores covering a longer period were given more weight. The minimum theoretical score is 0 units, which represents no pain relief (0 on scale) at all points after time 0. The maximum theoretical score is 192 units, which represents complete pain relief (4 on scale) at all points after 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 |
| Lost to Follow-up |
|
| Adverse Event |
|
| Investigator Decision |
|
| BG002 | Indomethacin 20 mg TID | Indomethacin Nanoformulation Capsules 20 mg TID |
| BG003 | Placebo | Placebo Group |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Subjects were allowed to select more than one race; therefore, some subjects are counted multiple times. | Number | participants |
|
| Weight (kg) | Weight measured in kilogram | Mean | Standard Deviation | KG |
|
| Height (cm) | Height measured in centimeters | Mean | Standard Deviation | CM |
|
| BMI (kg/m^2) | Body mass index measured in kilograms per meter squared. | Mean | Standard Deviation | KG/M^2 |
|
| Baseline pain intensity, mm | 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". | Mean | Standard Deviation | mm |
|
| Surgery duration, min | Surgery duration, minutes | Mean | Standard Deviation | minutes |
|
| OG000 | Indomethacin 40 mg TID | Indomethacin Nanoformulation Capsules 40 mg TID |
| OG001 | Indomethacin 40 mg BID | Indomethacin Nanoformulation Capsules 40 mg BID |
| OG002 | Indomethacin 20 mg TID | Indomethacin Nanoformulation Capsules 20 mg TID |
| OG003 | Placebo | Placebo Group |
|
|
|
| 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". Pain intensity is assessed at baseline (time "0") and at the following time points after time 0: 15, 30, and 45 minutes and 1, 1.5, 2, 3, and 4 hours. 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. All subjects who received at least 1 dose of trial drug. | 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". Pain intensity is assessed at baseline (time "0") and at the following time points after time 0: 15, 30, and 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 hours. 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. All subjects who received at least 1 dose of trial drug. | 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". Pain intensity is assessed at baseline (time "0") and at the following time points after time 0: 15, 30, and 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, and 24 hours. 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. All subjects who received at least 1 dose of trial drug. | 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 with a 5-point categorical scale at all assessment timepoints 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. Pain relief is assessed at the following points after time 0: 15, 30 & 45 minutes and 1, 1.5, 2, 3 & 4 hours. 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. Thus, individual scores covering a longer period were given more weight. The minimum theoretical score is 0 units, which represents no pain relief (0 on scale) at all points after time 0. The maximum theoretical score is 16 units, which represents complete pain relief (4 on scale) at all points after 0. | 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 with a 5-point categorical scale at all assessment timepoints 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. Pain relief is assessed at the following points after time 0: 15, 30 & 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7 & 8 hours. 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. Thus, individual scores covering a longer period were given more weight. The minimum theoretical score is 0 units, which represents no pain relief (0 on scale) at all points after time 0. The maximum theoretical score is 32 units, which represents complete pain relief (4 on scale) at all points after 0. | Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug. | 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 with a 5-point categorical scale at all assessment timepoints 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. Pain relief is assessed at the following points after time 0: 15, 30 & 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, & 24 hours. 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. Thus, individual scores covering a longer period were given more weight. The minimum theoretical score is 0 units, which represents no pain relief (0 on scale) at all points after time 0. The maximum theoretical score is 96 units, which represents complete pain relief (4 on scale) at all points after 0. | Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug. | 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 with a 5-point categorical scale at all assessment timepoints 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. Pain relief is assessed at the following points after time 0: 15, 30 & 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 32, 40 & 48 hours. 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. Thus, individual scores covering a longer period were given more weight. The minimum theoretical score is 0 units, which represents no pain relief (0 on scale) at all points after time 0. The maximum theoretical score is 192 units, which represents complete pain relief (4 on scale) at all points after 0. | Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug. | Posted | Mean | Standard Deviation | units on a scale*hour | 0-48 hours |
|
|
|
|
| 0 |
| 94 |
| 65 |
| 94 |
| EG001 | Indomethacin 40 mg BID | Indomethacin Nanoformulation Capsules 40 mg BID | 0 | 93 | 74 | 93 |
| EG002 | Indomethacin 20 mg TID | Indomethacin Nanoformulation Capsules 20 mg TID | 0 | 92 | 68 | 92 |
| EG003 | Placebo | Placebo Group | 0 | 94 | 71 | 94 |
| Postprocedural edema | Injury, poisoning and procedural complications |
|
| Dizziness | Nervous system disorders |
|
| Headache | Nervous system disorders |
|
| Vomiting | Gastrointestinal disorders |
|
| Constipation | Gastrointestinal disorders |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications |
|
Not provided
Not provided
| No |
| Superiority or Other |
| t-test, 2 sided | 0.461 | No | Superiority or Other |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.458 | No | Superiority or Other |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.441 | No | Superiority or Other |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.716 | No | Superiority or Other |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.593 | No | Superiority or Other |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.447 | No | Superiority or Other |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.577 | No | Superiority or Other |