Trial Outcomes & Findings for Study of Diclofenac Capsules to Treat Pain Following Bunionectomy (NCT NCT01462435)

NCT ID: NCT01462435

Last Updated: 2014-02-04

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". 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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 428 participants
• Primary outcome timeframe: 0 - 48 hours
• Results posted on: 2014-02-04

Participant Flow

Participant milestones

Measure	Celecoxib Celecoxib : 200 mg Capsules	Diclofenac Test (Lower Dose) Diclofenac Test (lower dose) : Capsules	Diclofenac Test (Upper Dose) Diclofenac Test (upper dose) : Capsules	Placebo Placebo : Capsules
Overall Study STARTED	106	109	107	106
Overall Study COMPLETED	105	109	106	101
Overall Study NOT COMPLETED	1	0	1	5

Reasons for withdrawal

Measure	Celecoxib Celecoxib : 200 mg Capsules	Diclofenac Test (Lower Dose) Diclofenac Test (lower dose) : Capsules	Diclofenac Test (Upper Dose) Diclofenac Test (upper dose) : Capsules	Placebo Placebo : Capsules
Overall Study Lack of Efficacy	1	0	0	3
Overall Study Physician Decision	0	0	1	0
Overall Study Withdrawal by Subject	0	0	0	1
Overall Study Lost to Follow-up	0	0	0	1

Baseline Characteristics

Study of Diclofenac Capsules to Treat Pain Following Bunionectomy

Baseline characteristics by cohort

Measure	Celecoxib n=106 Participants Celecoxib : 200 mg Capsules	Diclofenac Test (Lower Dose) n=109 Participants Diclofenac Test (lower dose) : Capsules	Diclofenac Test (Upper Dose) n=107 Participants Diclofenac Test (upper dose) : Capsules	Placebo n=106 Participants Placebo : Capsules	Total n=428 Participants Total of all reporting groups
Age, Continuous	40.3 years STANDARD_DEVIATION 11.9 • n=93 Participants	39.4 years STANDARD_DEVIATION 11.7 • n=4 Participants	39.3 years STANDARD_DEVIATION 11.8 • n=27 Participants	39.9 years STANDARD_DEVIATION 12.6 • n=483 Participants	39.7 years STANDARD_DEVIATION 12.0 • n=36 Participants
Sex: Female, Male Female	96 Participants n=93 Participants	94 Participants n=4 Participants	89 Participants n=27 Participants	92 Participants n=483 Participants	371 Participants n=36 Participants
Sex: Female, Male Male	10 Participants n=93 Participants	15 Participants n=4 Participants	18 Participants n=27 Participants	14 Participants n=483 Participants	57 Participants n=36 Participants
Region of Enrollment United States	106 participants n=93 Participants	109 participants n=4 Participants	107 participants n=27 Participants	106 participants n=483 Participants	428 participants n=36 Participants

PRIMARY outcome

Timeframe: 0 - 48 hours

Population: Intent-to-Treat Population

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.

Outcome measures

Measure	Celecoxib n=106 Participants Celecoxib : 200 mg Capsules	Diclofenac Test (Lower Dose) n=109 Participants Diclofenac Test (lower dose) : Capsules	Diclofenac Test (Upper Dose) n=107 Participants Diclofenac Test (upper dose) : Capsules	Placebo n=106 Participants Placebo : Capsules
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), ANCOVA Model.	390.468 mm*hour Standard Deviation 925.1	392.954 mm*hour Standard Deviation 937.0	524.315 mm*hour Standard Deviation 1146.1	76.887 mm*hour Standard Deviation 340.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Celecoxib n=106 Participants Celecoxib : 200 mg Capsules	Diclofenac Test (Lower Dose) n=109 Participants Diclofenac Test (lower dose) : Capsules	Diclofenac Test (Upper Dose) n=107 Participants Diclofenac Test (upper dose) : Capsules	Placebo n=106 Participants Placebo : Capsules
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.	25.109 mm*hour Standard Deviation 62.9	27.450 mm*hour Standard Deviation 64.9	31.568 mm*hour Standard Deviation 68.6	14.406 mm*hour Standard Deviation 53.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Celecoxib n=106 Participants Celecoxib : 200 mg Capsules	Diclofenac Test (Lower Dose) n=109 Participants Diclofenac Test (lower dose) : Capsules	Diclofenac Test (Upper Dose) n=107 Participants Diclofenac Test (upper dose) : Capsules	Placebo n=106 Participants Placebo : Capsules
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.	51.675 mm*hour Standard Deviation 122.4	56.404 mm*hour Standard Deviation 132.6	64.689 mm*hour Standard Deviation 138.5	23.151 mm*hour Standard Deviation 84.9

SECONDARY outcome

Timeframe: 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 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	Celecoxib n=106 Participants Celecoxib : 200 mg Capsules	Diclofenac Test (Lower Dose) n=109 Participants Diclofenac Test (lower dose) : Capsules	Diclofenac Test (Upper Dose) n=107 Participants Diclofenac Test (upper dose) : Capsules	Placebo n=106 Participants Placebo : Capsules
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.	170.845 mm*hour Standard Deviation 393.0	177.101 mm*hour Standard Deviation 418.3	230.708 mm*hour Standard Deviation 499.9	48.811 mm*hour Standard Deviation 186.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Celecoxib n=106 Participants Celecoxib : 200 mg Capsules	Diclofenac Test (Lower Dose) n=109 Participants Diclofenac Test (lower dose) : Capsules	Diclofenac Test (Upper Dose) n=107 Participants Diclofenac Test (upper dose) : Capsules	Placebo n=106 Participants Placebo : Capsules
Total Pain Relief (TOTPAR) Over 0 to 4 Hours. TOTPAR-4.	2.226 units on a scale*hour Standard Deviation 3.5	2.112 units on a scale*hour Standard Deviation 3.5	2.530 units on a scale*hour Standard Deviation 3.6	1.387 units on a scale*hour Standard Deviation 2.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Celecoxib n=106 Participants Celecoxib : 200 mg Capsules	Diclofenac Test (Lower Dose) n=109 Participants Diclofenac Test (lower dose) : Capsules	Diclofenac Test (Upper Dose) n=107 Participants Diclofenac Test (upper dose) : Capsules	Placebo n=106 Participants Placebo : Capsules
TOTPAR-8. Total Pain Relief (TOTPAR) Over 0 to 8 Hours	3.840 units on a scale*hour Standard Deviation 6.8	3.690 units on a scale*hour Standard Deviation 6.8	4.652 units on a scale*hour Standard Deviation 7.5	1.943 units on a scale*hour Standard Deviation 4.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Celecoxib n=106 Participants Celecoxib : 200 mg Capsules	Diclofenac Test (Lower Dose) n=109 Participants Diclofenac Test (lower dose) : Capsules	Diclofenac Test (Upper Dose) n=107 Participants Diclofenac Test (upper dose) : Capsules	Placebo n=106 Participants Placebo : Capsules
TOTPAR-24. Total Pain Relief (TOTPAR) Over 0 to 24 Hours	10.670 units on a scale*hour Standard Deviation 22.2595	10.186 units on a scale*hour Standard Deviation 21.3384	13.325 units on a scale*hour Standard Deviation 25.9326	3.566 units on a scale*hour Standard Deviation 10.8804

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Celecoxib n=106 Participants Celecoxib : 200 mg Capsules	Diclofenac Test (Lower Dose) n=109 Participants Diclofenac Test (lower dose) : Capsules	Diclofenac Test (Upper Dose) n=107 Participants Diclofenac Test (upper dose) : Capsules	Placebo n=106 Participants Placebo : Capsules
TOTPAR-48. Total Pain Relief (TOTPAR) Over 0 to 48 Hours	22.972 units on a scale*hour Standard Deviation 51.1	21.635 units on a scale*hour Standard Deviation 48.	28.054 units on a scale*hour Standard Deviation 58.1	4.925 units on a scale*hour Standard Deviation 19.4

Adverse Events

Celecoxib

Serious events: 1 serious events

Other events: 86 other events

Deaths: 0 deaths

Diclofenac Test (Lower Dose)

Serious events: 0 serious events

Other events: 84 other events

Deaths: 0 deaths

Diclofenac Test (Upper Dose)

Serious events: 0 serious events

Other events: 77 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 63 other events

Deaths: 0 deaths

Serious adverse events

Measure	Celecoxib n=106 participants at risk Celecoxib : 200 mg Capsules	Diclofenac Test (Lower Dose) n=109 participants at risk Diclofenac Test (lower dose) : Capsules	Diclofenac Test (Upper Dose) n=107 participants at risk Diclofenac Test (upper dose) : Capsules	Placebo n=106 participants at risk Placebo : Capsules
Vascular disorders Deep vein thrombosis	0.94% 1/106 • Number of events 1	0.00% 0/109	0.00% 0/107	0.00% 0/106

Other adverse events

Measure	Celecoxib n=106 participants at risk Celecoxib : 200 mg Capsules	Diclofenac Test (Lower Dose) n=109 participants at risk Diclofenac Test (lower dose) : Capsules	Diclofenac Test (Upper Dose) n=107 participants at risk Diclofenac Test (upper dose) : Capsules	Placebo n=106 participants at risk Placebo : Capsules
Injury, poisoning and procedural complications Postprocedural edema	33.0% 35/106	33.0% 36/109	32.7% 35/107	32.1% 34/106
Gastrointestinal disorders Nausea	27.4% 29/106	31.2% 34/109	23.4% 25/107	36.8% 39/106
Nervous system disorders Headache	10.4% 11/106	15.6% 17/109	10.3% 11/107	15.1% 16/106
Nervous system disorders Dizziness	10.4% 11/106	15.6% 17/109	4.7% 5/107	16.0% 17/106
Gastrointestinal disorders Vomiting	14.2% 15/106	11.9% 13/109	6.5% 7/107	12.3% 13/106
Injury, poisoning and procedural complications Postprocedural hematoma	7.5% 8/106	11.0% 12/109	3.7% 4/107	10.4% 11/106
Gastrointestinal disorders Constipation	8.5% 9/106	11.0% 12/109	5.6% 6/107	3.8% 4/106
Skin and subcutaneous tissue disorders Pruritus	3.8% 4/106	3.7% 4/109	5.6% 6/107	3.8% 4/106
Nervous system disorders Paraesthesia	7.5% 8/106	1.8% 2/109	1.9% 2/107	2.8% 3/106

Additional Information

Daniel Solorio

Iroko Pharmaceuticals, LLC

Phone: 267-546-3150

Email: dsolorio@iroko.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place