Study of Indomethacin Capsules to Treat Pain Following Bunionectomy
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Purpose
The purpose of this study is to determine whether Indomethacin [Test] Capsules are safe and effective for the treatment of postoperative bunionectomy pain.
| Condition | Intervention | Phase |
|---|---|---|
|
Other Acute Postoperative Pain |
Drug: Indomethacin Drug: Celecoxib Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase 3, Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Active- and Placebo-Controlled Study of Indomethacin [Test] Capsules for the Treatment of Acute Postoperative Pain After Bunionectomy |
- 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) [ Time Frame: 0 - 48 hours ] [ Designated as safety issue: No ]
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.
- 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. [ Time Frame: 0 - 4 hours ] [ Designated as safety issue: No ]
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.
- 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. [ Time Frame: 0 - 8 hours ] [ Designated as safety issue: No ]
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.
- 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 [ Time Frame: 0 - 24 hours ] [ Designated as safety issue: No ]
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.
- Total Pain Relief (TOTPAR) Over 0 to 4 Hours (TOTPAR-4). [ Time Frame: 0 - 4 hours ] [ Designated as safety issue: No ]
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.
- TOTPAR-8. Total Pain Relief (TOTPAR) Over 0 to 8 Hours [ Time Frame: 0 - 8 hours ] [ Designated as safety issue: No ]
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.
- TOTPAR-24. Total Pain Relief (TOTPAR) Over 0 to 24 Hours [ Time Frame: 0 - 24 hours ] [ Designated as safety issue: No ]
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.
- TOTPAR-48. Total Pain Relief (TOTPAR) Over 0 to 48 Hours [ Time Frame: 0 - 48 hours ] [ Designated as safety issue: No ]
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.
| Enrollment: | 462 |
| Study Start Date: | February 2012 |
| Study Completion Date: | July 2012 |
| Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Indomethacin 40 mg TID |
Drug: Indomethacin
40 mg TID capsules
|
| Experimental: Indomethacin 40 mg BID |
Drug: Indomethacin
40 mg BID capsules
|
| Experimental: Indomethacin 20 mg TID |
Drug: Indomethacin
20 mg TID capsules
|
| Active Comparator: Celecoxib 200 mg |
Drug: Celecoxib
200 mg capsules
|
| Placebo Comparator: Placebo |
Drug: Placebo
Capsules
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient is male or female between 18 and 65 years of age
- For women of child-bearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control
- Has undergone primary, unilateral, first metatarsal bunionectomy with no additional collateral procedures
- Patient must be willing to stay at the study site ≥ 72 hours
Exclusion Criteria:
- Patient has hypersensitivity, allergy, or clinically significant intolerance to any medications to be used in the study, or related drugs
- Patient has a current disease or history of a disease that will impact the study or the patient's well-being
- Patient has used or intends to use any of the medications that are prohibited by the protocol
- Patient has a history of drug or alcohol abuse or dependence, or patient has a positive urine drug screen or alcohol breathalyzer test
- Patient has taken another investigational drug within 30 days prior to screening
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01543685
| United States, Arizona | |
| Premier Research Group Limited | |
| Phoenix, Arizona, United States, 85027 | |
| United States, Maryland | |
| Chesapeake Research Group, LLC | |
| Pasadena, Maryland, United States, 21122 | |
| United States, Texas | |
| Premier Research Group Limited | |
| Austin, Texas, United States, 78705 | |
| United States, Utah | |
| Premier Research Group Limited | |
| Salt Lake City, Utah, United States, 84107 | |
| Principal Investigator: | 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 |
More Information
No publications provided
| Responsible Party: | Iroko Pharmaceuticals, LLC |
| ClinicalTrials.gov Identifier: | NCT01543685 History of Changes |
| Other Study ID Numbers: | IND3-08-04b |
| Study First Received: | February 28, 2012 |
| Results First Received: | February 27, 2013 |
| Last Updated: | January 2, 2014 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Pain, Postoperative Pain Pathologic Processes Postoperative Complications Signs and Symptoms Indomethacin Analgesics Analgesics, Non-Narcotic Anti-Inflammatory Agents Anti-Inflammatory Agents, Non-Steroidal Antirheumatic Agents Cardiovascular Agents |
Central Nervous System Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Gout Suppressants Molecular Mechanisms of Pharmacological Action Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Reproductive Control Agents Sensory System Agents Therapeutic Uses Tocolytic Agents |
ClinicalTrials.gov processed this record on February 27, 2015