Trial · NCT01543685
Study of Indomethacin Capsules to Treat Pain Following Bunionectomy
NCT01543685, Phase 3, Completed, Iroko Pharmaceuticals, LLC; results first posted 2013-12-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Indomethacin Capsules to Treat Pain Following Bunionectomy. Trials, record NCT01543685. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01543685
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Indomethacin Capsules to Treat Pain Following Bunionectomy
- NCT number
- NCT01543685
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 462 participants, actual
- Lead sponsor
- Iroko Pharmaceuticals, LLC
- Conditions
- Other Acute Postoperative Pain
- Interventions
- Indomethacin, Indomethacin, Indomethacin, Celecoxib, Placebo
- First posted
- 2012-03-05
- Last updated
- 2014-02-04
- Results first posted
- 2013-12-19
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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) | 0 - 48 hours | 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. |
| 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. | 0 - 4 hours | 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. |
| 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. | 0 - 8 hours | 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. |
| 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 | 0 - 24 hours | 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. |
| Secondary | Total Pain Relief (TOTPAR) Over 0 to 4 Hours (TOTPAR-4). | 0 - 4 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 16 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0. |
| Secondary | TOTPAR-8. Total Pain Relief (TOTPAR) Over 0 to 8 Hours | 0 - 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. |
| Secondary | TOTPAR-24. Total Pain Relief (TOTPAR) Over 0 to 24 Hours | 0 - 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. |
| Secondary | TOTPAR-48. Total Pain Relief (TOTPAR) Over 0 to 48 Hours | 0 - 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. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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) | 0 - 48 hours | Intent to Treat Population | mm*hour | MEAN |
| 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. | 0 - 4 hours | Intent to Treat Population | mm*hour | MEAN |
| 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. | 0 - 8 hours | Intent to Treat Population | mm*hour | MEAN |
| 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 | 0 - 24 hours | Intent to Treat Population | mm*hour | MEAN |
| SECONDARY | Total Pain Relief (TOTPAR) Over 0 to 4 Hours (TOTPAR-4). | 0 - 4 hours | Intent to Treat Population | units on a scale*hour | MEAN |
| SECONDARY | TOTPAR-8. Total Pain Relief (TOTPAR) Over 0 to 8 Hours | 0 - 8 hours | Intent to Treat Population | units on a scale*hour | MEAN |
| SECONDARY | TOTPAR-24. Total Pain Relief (TOTPAR) Over 0 to 24 Hours | 0 - 24 hours | Intent to Treat Population | units on a scale*hour | MEAN |
| SECONDARY | TOTPAR-48. Total Pain Relief (TOTPAR) Over 0 to 48 Hours | 0 - 48 hours | Intent to Treat Population | units on a scale*hour | MEAN |
Source ClinicalTrials.gov
Results by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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) | Indomethacin 40 mg TID | 508.2 | Standard Deviation 1125.6 | mm*hour | |
| 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) | Indomethacin 40 mg BID | 329.8 | Standard Deviation 903.3 | mm*hour | |
| 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) | Indomethacin 20 mg TID | 377.3 | Standard Deviation 1045.1 | mm*hour | |
| 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) | Celecoxib 200 mg | 280.5 | Standard Deviation 799.8 | mm*hour | |
| 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) | Placebo | 69.4 | Standard Deviation 364.3 | mm*hour | |
| 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. | Indomethacin 40 mg TID | 30.7 | Standard Deviation 74.9 | mm*hour | |
| 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. | Indomethacin 40 mg BID | 29.8 | Standard Deviation 70.8 | mm*hour | |
| 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. | Indomethacin 20 mg TID | 17.9 | Standard Deviation 57.1 | mm*hour | |
| 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. | Celecoxib 200 mg | 20.4 | Standard Deviation 54.6 | mm*hour | |
| 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. | Placebo | 8.9 | Standard Deviation 38.3 | mm*hour |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Indomethacin 40 mg TID | 93 | |
| Overall Study | STARTED | Indomethacin 40 mg BID | 91 | |
| Overall Study | STARTED | Indomethacin 20 mg TID | 91 | |
| Overall Study | STARTED | Celecoxib 200 mg | 93 | |
| Overall Study | STARTED | Placebo | 94 | |
| Overall Study | COMPLETED | Indomethacin 40 mg TID | 90 | |
| Overall Study | COMPLETED | Indomethacin 40 mg BID | 88 | |
| Overall Study | COMPLETED | Indomethacin 20 mg TID | 89 | |
| Overall Study | COMPLETED | Celecoxib 200 mg | 93 | |
| Overall Study | COMPLETED | Placebo | 90 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events50
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Celecoxib 200 mg | 30 | 93 | |
| other | Nausea | Gastrointestinal disorders | Indomethacin 20 mg TID | 29 | 91 | |
| other | Nausea | Gastrointestinal disorders | Indomethacin 40 mg BID | 24 | 91 | |
| other | Nausea | Gastrointestinal disorders | Indomethacin 40 mg TID | 30 | 93 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 34 | 94 | |
| other | Dizziness | Nervous system disorders | Celecoxib 200 mg | 7 | 93 | |
| other | Dizziness | Nervous system disorders | Indomethacin 20 mg TID | 6 | 91 | |
| other | Dizziness | Nervous system disorders | Indomethacin 40 mg BID | 14 | 91 | |
| other | Dizziness | Nervous system disorders | Indomethacin 40 mg TID | 12 | 93 | |
| other | Dizziness | Nervous system disorders | Placebo | 16 | 94 |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Celecoxib 200 mg | ||
| Total, all-cause mortality | Indomethacin 20 mg TID | ||
| Total, all-cause mortality | Indomethacin 40 mg BID | ||
| Total, all-cause mortality | Indomethacin 40 mg TID | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Celecoxib 200 mg | 68 | 93 |
| Total, other adverse events | Indomethacin 20 mg TID | 69 | 91 |
| Total, other adverse events | Indomethacin 40 mg BID | 74 | 91 |
| Total, other adverse events | Indomethacin 40 mg TID | 66 | 93 |
| Total, other adverse events | Placebo | 71 | 94 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01543685
GET https://conductscience.org/api/trials/v1/NCT01543685/results?page=2