Study of Diclofenac Capsules to Treat Pain Following Bunionectomy

A Phase 3, Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Active- and Placebo-Controlled Study of Diclofenac [Test] Capsules for the Treatment of Acute Postoperative Pain After Bunionectomy

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01462435

Enrollment

428

Registered

2011-10-31

Start date

2011-10-31

Completion date

2012-08-31

Last updated

2014-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brief summary

The purpose of this study is to determine whether Diclofenac \[Test\] Capsules are safe and effective for the treatment of bunionectomy pain.

Interventions

DRUGDiclofenac Test (lower dose)

Capsules

DRUGDiclofenac Test (upper dose)

Capsules

DRUGCelecoxib

200 mg Capsules

DRUGPlacebo

Capsules

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.	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

Measure	Time frame	Description
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.
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 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.
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.
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.
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.
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.
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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Celecoxib Celecoxib : 200 mg Capsules	106
Diclofenac Test (Lower Dose) Diclofenac Test (lower dose) : Capsules	109
Diclofenac Test (Upper Dose) Diclofenac Test (upper dose) : Capsules	107
Placebo Placebo : Capsules	106
Total	428

Withdrawals & dropouts

Period	Reason	FG000	FG002	FG003
Overall Study	Lack of Efficacy	1	0	3
Overall Study	Lost to Follow-up	0	0	1
Overall Study	Physician Decision	0	1	0
Overall Study	Withdrawal by Subject	0	0	1

Baseline characteristics

Characteristic	Celecoxib	Diclofenac Test (Lower Dose)	Diclofenac Test (Upper Dose)	Placebo	Total
Age, Continuous	40.3 years STANDARD_DEVIATION 11.9	39.4 years STANDARD_DEVIATION 11.7	39.3 years STANDARD_DEVIATION 11.8	39.9 years STANDARD_DEVIATION 12.6	39.7 years STANDARD_DEVIATION 12
Region of Enrollment United States	106 participants	109 participants	107 participants	106 participants	428 participants
Sex: Female, Male Female	96 Participants	94 Participants	89 Participants	92 Participants	371 Participants
Sex: Female, Male Male	10 Participants	15 Participants	18 Participants	14 Participants	57 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —
other Total, other adverse events	86 / 106	84 / 109	77 / 107	63 / 106
serious Total, serious adverse events	1 / 106	0 / 109	0 / 107	0 / 106

Outcome results

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), ANCOVA Model.

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.

Time frame: 0 - 48 hours

Population: Intent-to-Treat Population

Arm	Measure	Value (MEAN)	Dispersion
Celecoxib	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
Diclofenac Test (Lower Dose)	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.	392.954 mm*hour	Standard Deviation 937
Diclofenac Test (Upper Dose)	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.	524.315 mm*hour	Standard Deviation 1146.1
Placebo	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.	76.887 mm*hour	Standard Deviation 340.6

p-value: <0.00195% CI: [206.567, 687.324]ANCOVA

p-value: 0.0195% CI: [77.136, 555.155]ANCOVA

p-value: 0.01195% CI: [72.202, 554.037]ANCOVA

Secondary

Total Pain Relief (TOTPAR) Over 0 to 4 Hours. TOTPAR-4.

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.

Time frame: 0 - 4 hours

Arm	Measure	Value (MEAN)	Dispersion
Celecoxib	Total Pain Relief (TOTPAR) Over 0 to 4 Hours. TOTPAR-4.	2.226 units on a scale*hour	Standard Deviation 3.5
Diclofenac Test (Lower Dose)	Total Pain Relief (TOTPAR) Over 0 to 4 Hours. TOTPAR-4.	2.112 units on a scale*hour	Standard Deviation 3.5
Diclofenac Test (Upper Dose)	Total Pain Relief (TOTPAR) Over 0 to 4 Hours. TOTPAR-4.	2.530 units on a scale*hour	Standard Deviation 3.6
Placebo	Total Pain Relief (TOTPAR) Over 0 to 4 Hours. TOTPAR-4.	1.387 units on a scale*hour	Standard Deviation 2.7

p-value: 0.009t-test, 2 sided

p-value: 0.091t-test, 2 sided

p-value: 0.053t-test, 2 sided

Secondary

TOTPAR-24. Total Pain Relief (TOTPAR) Over 0 to 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.

Time frame: 0 - 24 hours

Arm	Measure	Value (MEAN)	Dispersion
Celecoxib	TOTPAR-24. Total Pain Relief (TOTPAR) Over 0 to 24 Hours	10.670 units on a scale*hour	Standard Deviation 22.2595
Diclofenac Test (Lower Dose)	TOTPAR-24. Total Pain Relief (TOTPAR) Over 0 to 24 Hours	10.186 units on a scale*hour	Standard Deviation 21.3384
Diclofenac Test (Upper Dose)	TOTPAR-24. Total Pain Relief (TOTPAR) Over 0 to 24 Hours	13.325 units on a scale*hour	Standard Deviation 25.9326
Placebo	TOTPAR-24. Total Pain Relief (TOTPAR) Over 0 to 24 Hours	3.566 units on a scale*hour	Standard Deviation 10.8804

p-value: <0.001t-test, 2 sided

p-value: 0.005t-test, 2 sided

p-value: 0.004t-test, 2 sided

Secondary

TOTPAR-48. Total Pain Relief (TOTPAR) Over 0 to 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.

Time frame: 0 - 48 hours

Arm	Measure	Value (MEAN)	Dispersion
Celecoxib	TOTPAR-48. Total Pain Relief (TOTPAR) Over 0 to 48 Hours	22.972 units on a scale*hour	Standard Deviation 51.1
Diclofenac Test (Lower Dose)	TOTPAR-48. Total Pain Relief (TOTPAR) Over 0 to 48 Hours	21.635 units on a scale*hour	—
Diclofenac Test (Upper Dose)	TOTPAR-48. Total Pain Relief (TOTPAR) Over 0 to 48 Hours	28.054 units on a scale*hour	Standard Deviation 58.1
Placebo	TOTPAR-48. Total Pain Relief (TOTPAR) Over 0 to 48 Hours	4.925 units on a scale*hour	Standard Deviation 19.4

p-value: <0.001t-test, 2 sided

Secondary

TOTPAR-8. Total Pain Relief (TOTPAR) Over 0 to 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.

Time frame: 0 - 8 hours

Arm	Measure	Value (MEAN)	Dispersion
Celecoxib	TOTPAR-8. Total Pain Relief (TOTPAR) Over 0 to 8 Hours	3.840 units on a scale*hour	Standard Deviation 6.8
Diclofenac Test (Lower Dose)	TOTPAR-8. Total Pain Relief (TOTPAR) Over 0 to 8 Hours	3.690 units on a scale*hour	Standard Deviation 6.8
Diclofenac Test (Upper Dose)	TOTPAR-8. Total Pain Relief (TOTPAR) Over 0 to 8 Hours	4.652 units on a scale*hour	Standard Deviation 7.5
Placebo	TOTPAR-8. Total Pain Relief (TOTPAR) Over 0 to 8 Hours	1.943 units on a scale*hour	Standard Deviation 4.4

p-value: 0.002t-test, 2 sided

p-value: 0.026t-test, 2 sided

p-value: 0.017t-test, 2 sided

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.

Time frame: 0 - 24 hours

Arm	Measure	Value (MEAN)	Dispersion
Celecoxib	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
Diclofenac Test (Lower Dose)	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.	177.101 mm*hour	Standard Deviation 418.3
Diclofenac Test (Upper Dose)	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.	230.708 mm*hour	Standard Deviation 499.9
Placebo	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.	48.811 mm*hour	Standard Deviation 186.5

p-value: <0.001t-test, 2 sided

p-value: 0.004t-test, 2 sided

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.

Time frame: 0 - 4 hours

Arm	Measure	Value (MEAN)	Dispersion
Celecoxib	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
Diclofenac Test (Lower Dose)	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.	27.450 mm*hour	Standard Deviation 64.9
Diclofenac Test (Upper Dose)	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.	31.568 mm*hour	Standard Deviation 68.6
Placebo	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.	14.406 mm*hour	Standard Deviation 53.5

p-value: 0.043t-test, 2 sided

p-value: 0.109t-test, 2 sided

p-value: 0.183t-test, 2 sided

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.

Time frame: 0 - 8 hours

Arm	Measure	Value (MEAN)	Dispersion
Celecoxib	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
Diclofenac Test (Lower Dose)	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.	56.404 mm*hour	Standard Deviation 132.6
Diclofenac Test (Upper Dose)	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.	64.689 mm*hour	Standard Deviation 138.5
Placebo	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.	23.151 mm*hour	Standard Deviation 84.9

p-value: 0.009t-test, 2 sided

p-value: 0.029t-test, 2 sided

p-value: 0.05t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026

Study of Diclofenac Capsules to Treat Pain Following Bunionectomy

Conditions

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

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.

Total Pain Relief (TOTPAR) Over 0 to 4 Hours. TOTPAR-4.

TOTPAR-24. Total Pain Relief (TOTPAR) Over 0 to 24 Hours

TOTPAR-48. Total Pain Relief (TOTPAR) Over 0 to 48 Hours

TOTPAR-8. Total Pain Relief (TOTPAR) Over 0 to 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.

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.

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.