Trial Outcomes & Findings for Study of Indomethacin Capsules to Treat Pain Following Bunionectomy (NCT NCT01626118)
NCT ID: NCT01626118
Last Updated: 2014-03-17
Results Overview
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.
COMPLETED
PHASE3
373 participants
0-48 hours
2014-03-17
Participant Flow
Participant milestones
| Measure |
Indomethacin 40 mg TID
Indomethacin Nanoformulation Capsules 40 mg TID
|
Indomethacin 40 mg BID
Indomethacin Nanoformulation Capsules 40 mg BID
|
Indomethacin 20 mg TID
Indomethacin Nanoformulation Capsules 20 mg TID
|
Placebo
Placebo Group
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
94
|
93
|
92
|
94
|
|
Overall Study
COMPLETED
|
92
|
91
|
90
|
91
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
2
|
3
|
Reasons for withdrawal
| Measure |
Indomethacin 40 mg TID
Indomethacin Nanoformulation Capsules 40 mg TID
|
Indomethacin 40 mg BID
Indomethacin Nanoformulation Capsules 40 mg BID
|
Indomethacin 20 mg TID
Indomethacin Nanoformulation Capsules 20 mg TID
|
Placebo
Placebo Group
|
|---|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
1
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
1
|
0
|
|
Overall Study
Investigator Decision
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Study of Indomethacin Capsules to Treat Pain Following Bunionectomy
Baseline characteristics by cohort
| Measure |
Indomethacin 40 mg TID
n=94 Participants
Indomethacin Nanoformulation Capsules 40 mg TID
|
Indomethacin 40 mg BID
n=93 Participants
Indomethacin Nanoformulation Capsules 40 mg BID
|
Indomethacin 20 mg TID
n=92 Participants
Indomethacin Nanoformulation Capsules 20 mg TID
|
Placebo
n=94 Participants
Placebo Group
|
Total
n=373 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
40.2 years
STANDARD_DEVIATION 12.27 • n=5 Participants
|
38.9 years
STANDARD_DEVIATION 12.5 • n=7 Participants
|
41.3 years
STANDARD_DEVIATION 12.57 • n=5 Participants
|
40.7 years
STANDARD_DEVIATION 11.32 • n=4 Participants
|
40.3 years
STANDARD_DEVIATION 12.16 • n=21 Participants
|
|
Sex: Female, Male
Female
|
80 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
83 Participants
n=4 Participants
|
317 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
56 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
73 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
79 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
74 Participants
n=4 Participants
|
300 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
5 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
8 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
0 participants
n=4 Participants
|
3 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
15 participants
n=5 Participants
|
25 participants
n=7 Participants
|
21 participants
n=5 Participants
|
19 participants
n=4 Participants
|
80 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White or Caucasian
|
77 participants
n=5 Participants
|
66 participants
n=7 Participants
|
69 participants
n=5 Participants
|
70 participants
n=4 Participants
|
282 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
3 participants
n=21 Participants
|
|
Weight (kg)
|
73.81 KG
STANDARD_DEVIATION 14.686 • n=5 Participants
|
72.77 KG
STANDARD_DEVIATION 15.761 • n=7 Participants
|
74.99 KG
STANDARD_DEVIATION 17.821 • n=5 Participants
|
71.22 KG
STANDARD_DEVIATION 14.607 • n=4 Participants
|
73.19 KG
STANDARD_DEVIATION 15.758 • n=21 Participants
|
|
Height (cm)
|
166.28 CM
STANDARD_DEVIATION 8.059 • n=5 Participants
|
165.65 CM
STANDARD_DEVIATION 8.994 • n=7 Participants
|
166.52 CM
STANDARD_DEVIATION 9.761 • n=5 Participants
|
165.61 CM
STANDARD_DEVIATION 7.646 • n=4 Participants
|
166.01 CM
STANDARD_DEVIATION 8.621 • n=21 Participants
|
|
BMI (kg/m^2)
|
26.5 KG/M^2
STANDARD_DEVIATION 4.49 • n=5 Participants
|
26.3 KG/M^2
STANDARD_DEVIATION 4.34 • n=7 Participants
|
26.7 KG/M^2
STANDARD_DEVIATION 4.73 • n=5 Participants
|
25.8 KG/M^2
STANDARD_DEVIATION 4.57 • n=4 Participants
|
26.3 KG/M^2
STANDARD_DEVIATION 4.52 • n=21 Participants
|
|
Baseline pain intensity, mm
|
71.0 mm
STANDARD_DEVIATION 16.33 • n=5 Participants
|
71.2 mm
STANDARD_DEVIATION 16.11 • n=7 Participants
|
72.3 mm
STANDARD_DEVIATION 15.90 • n=5 Participants
|
73.9 mm
STANDARD_DEVIATION 16.6 • n=4 Participants
|
72.1 mm
STANDARD_DEVIATION 16.21 • n=21 Participants
|
|
Surgery duration, min
|
27.7 minutes
STANDARD_DEVIATION 7.45 • n=5 Participants
|
27.6 minutes
STANDARD_DEVIATION 7.95 • n=7 Participants
|
28.5 minutes
STANDARD_DEVIATION 8.63 • n=5 Participants
|
27.2 minutes
STANDARD_DEVIATION 6.59 • n=4 Participants
|
27.7 minutes
STANDARD_DEVIATION 7.67 • n=21 Participants
|
PRIMARY outcome
Timeframe: 0-48 hoursPopulation: Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug.
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.
Outcome measures
| Measure |
Indomethacin 40 mg TID
n=94 Participants
Indomethacin Nanoformulation Capsules 40 mg TID
|
Indomethacin 40 mg BID
n=93 Participants
Indomethacin Nanoformulation Capsules 40 mg BID
|
Indomethacin 20 mg TID
n=92 Participants
Indomethacin Nanoformulation Capsules 20 mg TID
|
Placebo
n=94 Participants
Placebo Group
|
|---|---|---|---|---|
|
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)
|
598.670 mm*hour
Standard Deviation 1173.7863
|
623.162 mm*hour
Standard Deviation 1182.0912
|
342.779 mm*hour
Standard Deviation 858.6326
|
280.517 mm*hour
Standard Deviation 817.6026
|
SECONDARY outcome
Timeframe: 0-4 hoursPopulation: Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug.
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.
Outcome measures
| Measure |
Indomethacin 40 mg TID
n=94 Participants
Indomethacin Nanoformulation Capsules 40 mg TID
|
Indomethacin 40 mg BID
n=93 Participants
Indomethacin Nanoformulation Capsules 40 mg BID
|
Indomethacin 20 mg TID
n=92 Participants
Indomethacin Nanoformulation Capsules 20 mg TID
|
Placebo
n=94 Participants
Placebo Group
|
|---|---|---|---|---|
|
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.
|
31.5 mm*hour
Standard Deviation 74.4
|
35.3 mm*hour
Standard Deviation 79.6
|
24.8 mm*hour
Standard Deviation 54.6
|
18.4 mm*hour
Standard Deviation 62.1
|
SECONDARY outcome
Timeframe: 0-8 hoursPopulation: Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug.
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.
Outcome measures
| Measure |
Indomethacin 40 mg TID
n=94 Participants
Indomethacin Nanoformulation Capsules 40 mg TID
|
Indomethacin 40 mg BID
n=93 Participants
Indomethacin Nanoformulation Capsules 40 mg BID
|
Indomethacin 20 mg TID
n=92 Participants
Indomethacin Nanoformulation Capsules 20 mg TID
|
Placebo
n=94 Participants
Placebo Group
|
|---|---|---|---|---|
|
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.
|
69.7 mm*hour
Standard Deviation 151.7
|
75.5 mm*hour
Standard Deviation 152.5
|
47.6 mm*hour
Standard Deviation 109.9
|
35.8 mm*hour
Standard Deviation 107.9
|
SECONDARY outcome
Timeframe: 0-24 hoursPopulation: Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug.
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.
Outcome measures
| Measure |
Indomethacin 40 mg TID
n=94 Participants
Indomethacin Nanoformulation Capsules 40 mg TID
|
Indomethacin 40 mg BID
n=93 Participants
Indomethacin Nanoformulation Capsules 40 mg BID
|
Indomethacin 20 mg TID
n=92 Participants
Indomethacin Nanoformulation Capsules 20 mg TID
|
Placebo
n=94 Participants
Placebo Group
|
|---|---|---|---|---|
|
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.
|
268.4 mm*hour
Standard Deviation 526.9
|
265.2 mm*hour
Standard Deviation 516.2
|
156.8 mm*hour
Standard Deviation 384.0
|
115.5 mm*hour
Standard Deviation 346.5
|
SECONDARY outcome
Timeframe: 0-4 hoursPain 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.
Outcome measures
| Measure |
Indomethacin 40 mg TID
n=94 Participants
Indomethacin Nanoformulation Capsules 40 mg TID
|
Indomethacin 40 mg BID
n=93 Participants
Indomethacin Nanoformulation Capsules 40 mg BID
|
Indomethacin 20 mg TID
n=92 Participants
Indomethacin Nanoformulation Capsules 20 mg TID
|
Placebo
n=94 Participants
Placebo Group
|
|---|---|---|---|---|
|
Total Pain Relief (TOTPAR) Over 0 to 4 Hours (TOTPAR-4).
|
2.6 units on a scale*hour
Standard Deviation 3.8
|
2.8 units on a scale*hour
Standard Deviation 3.8
|
2.0 units on a scale*hour
Standard Deviation 2.9
|
1.9 units on a scale*hour
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: 0-8 hoursPopulation: Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug.
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.
Outcome measures
| Measure |
Indomethacin 40 mg TID
n=94 Participants
Indomethacin Nanoformulation Capsules 40 mg TID
|
Indomethacin 40 mg BID
n=93 Participants
Indomethacin Nanoformulation Capsules 40 mg BID
|
Indomethacin 20 mg TID
n=92 Participants
Indomethacin Nanoformulation Capsules 20 mg TID
|
Placebo
n=94 Participants
Placebo Group
|
|---|---|---|---|---|
|
TOTPAR-8. Total Pain Relief (TOTPAR) Over 0 to 8 Hours
|
5.0 units on a scale*hour
Standard Deviation 8.0
|
5.4 units on a scale*hour
Standard Deviation 8.1
|
3.5 units on a scale*hour
Standard Deviation 5.9
|
3.0 units on a scale*hour
Standard Deviation 5.8
|
SECONDARY outcome
Timeframe: 0-24 hoursPopulation: Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug.
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.
Outcome measures
| Measure |
Indomethacin 40 mg TID
n=94 Participants
Indomethacin Nanoformulation Capsules 40 mg TID
|
Indomethacin 40 mg BID
n=93 Participants
Indomethacin Nanoformulation Capsules 40 mg BID
|
Indomethacin 20 mg TID
n=92 Participants
Indomethacin Nanoformulation Capsules 20 mg TID
|
Placebo
n=94 Participants
Placebo Group
|
|---|---|---|---|---|
|
TOTPAR-24. Total Pain Relief (TOTPAR) Over 0 to 24 Hours
|
16.2 units on a scale*hour
Standard Deviation 29.1
|
16.8 units on a scale*hour
Standard Deviation 28.0
|
10.1 units on a scale*hour
Standard Deviation 21.8
|
7.8 units on a scale*hour
Standard Deviation 19.1
|
SECONDARY outcome
Timeframe: 0-48 hoursPopulation: Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug.
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.
Outcome measures
| Measure |
Indomethacin 40 mg TID
n=94 Participants
Indomethacin Nanoformulation Capsules 40 mg TID
|
Indomethacin 40 mg BID
n=93 Participants
Indomethacin Nanoformulation Capsules 40 mg BID
|
Indomethacin 20 mg TID
n=92 Participants
Indomethacin Nanoformulation Capsules 20 mg TID
|
Placebo
n=94 Participants
Placebo Group
|
|---|---|---|---|---|
|
TOTPAR-48. Total Pain Relief (TOTPAR) Over 0 to 48 Hours
|
34.7 units on a scale*hour
Standard Deviation 65.1
|
37.0 units on a scale*hour
Standard Deviation 64.5
|
21.2 units on a scale*hour
Standard Deviation 49.3
|
17.3 units on a scale*hour
Standard Deviation 45.6
|
Adverse Events
Indomethacin 40 mg TID
Indomethacin 40 mg BID
Indomethacin 20 mg TID
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Indomethacin 40 mg TID
n=94 participants at risk
Indomethacin Nanoformulation Capsules 40 mg TID
|
Indomethacin 40 mg BID
n=93 participants at risk
Indomethacin Nanoformulation Capsules 40 mg BID
|
Indomethacin 20 mg TID
n=92 participants at risk
Indomethacin Nanoformulation Capsules 20 mg TID
|
Placebo
n=94 participants at risk
Placebo Group
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
34.0%
32/94
|
38.7%
36/93
|
37.0%
34/92
|
35.1%
33/94
|
|
Injury, poisoning and procedural complications
Postprocedural edema
|
21.3%
20/94
|
19.4%
18/93
|
27.2%
25/92
|
30.9%
29/94
|
|
Nervous system disorders
Dizziness
|
17.0%
16/94
|
12.9%
12/93
|
13.0%
12/92
|
17.0%
16/94
|
|
Nervous system disorders
Headache
|
18.1%
17/94
|
12.9%
12/93
|
9.8%
9/92
|
14.9%
14/94
|
|
Gastrointestinal disorders
Vomiting
|
9.6%
9/94
|
12.9%
12/93
|
12.0%
11/92
|
8.5%
8/94
|
|
Gastrointestinal disorders
Constipation
|
3.2%
3/94
|
7.5%
7/93
|
8.7%
8/92
|
5.3%
5/94
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
4.3%
4/94
|
7.5%
7/93
|
3.3%
3/92
|
5.3%
5/94
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place