Study of Diclofenac Capsules to Treat Pain Following Bunionectomy

• Sponsor: Iroko Pharmaceuticals, LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01462435
• Collaborator: (none)
• Enrollment: 428
• Locations: 4
• Arms: 4
• Duration (Months): 10
• Patients Per Site: 107
• Patients Per Site Per Month: 10.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Other Acute Postoperative Pain	Drug: Diclofenac Test (lower dose); Drug: Diclofenac Test (upper dose); Drug: Celecoxib; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 428 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: Oct 1, 2011
• Actual Primary Completion Date: Feb 1, 2012
• Actual Study Completion Date: Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Diclofenac Test (lower dose)	Drug: Diclofenac Test (lower dose); Capsules
Experimental: Diclofenac Test (upper dose)	Drug: Diclofenac Test (upper dose); Capsules
Active Comparator: Celecoxib	Drug: Celecoxib; 200 mg Capsules
Placebo Comparator: Placebo	Drug: Placebo; Capsules

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• 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 Locations

Locations

	Site	City	State	Country	Postal Code
1	Premier Research Group Limited	Phoenix	Arizona	United States	85027
2	Chesapeake Research Group, LLC	Pasadena	Maryland	United States	21122
3	Premier Research Group Limited	Austin	Texas	United States	78705
4	Premier Research Group Limited	Salt Lake City	Utah	United States	84107

Sponsors and Collaborators

• Iroko Pharmaceuticals, LLC

Investigators

• 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
• Principal Investigator: S. Thomas Schiffgen, DPM, Premier Research Group Limited

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Iroko Pharmaceuticals, LLC
• ClinicalTrials.gov Identifier: NCT01462435
• Other Study ID Numbers: DIC3-08-04
• First Posted: Oct 31, 2011
• Last Update Posted: Feb 4, 2014
• Last Verified: Jan 1, 2014

• Additional relevant MeSH terms: Pain, Postoperative; Celecoxib; Diclofenac

Study Results

Participant Flow

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

Baseline Characteristics

Arm/Group Title	Celecoxib	Diclofenac Test (Lower Dose)	Diclofenac Test (Upper Dose)	Placebo	Total
Arm/Group Description	Celecoxib : 200 mg Capsules	Diclofenac Test (lower dose) : Capsules	Diclofenac Test (upper dose) : Capsules	Placebo : Capsules	Total of all reporting groups
Overall Participants	106	109	107	106	428
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	40.3 (11.9)	39.4 (11.7)	39.3 (11.8)	39.9 (12.6)	39.7 (12.0)
Sex: Female, Male (Count of Participants)
Female	96 90.6%	94 86.2%	89 83.2%	92 86.8%	371 86.7%
Male	10 9.4%	15 13.8%	18 16.8%	14 13.2%	57 13.3%
Region of Enrollment (participants) [Number]
United States	106 100%	109 100%	107 100%	106 100%	428 100%

Outcome Measures

1. Primary Outcome

Title	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.
Description	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

Outcome Measure Data

Analysis Population Description

Intent-to-Treat Population

Arm/Group Title	Celecoxib	Diclofenac Test (Lower Dose)	Diclofenac Test (Upper Dose)	Placebo
Arm/Group Description	Celecoxib : 200 mg Capsules	Diclofenac Test (lower dose) : Capsules	Diclofenac Test (upper dose) : Capsules	Placebo : Capsules
Measure Participants	106	109	107	106
Mean (Standard Deviation) [mm*hour]	390.468 (925.1)	392.954 (937.0)	524.315 (1146.1)	76.887 (340.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Diclofenac Test (Upper Dose), Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference in Least Squares Mean
	Estimated Value	446.946
	Confidence Interval	(2-Sided) 95%; 206.567 to 687.324
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 122.2935
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Diclofenac Test (Lower Dose), Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.010
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference in Least Squares Mean
	Estimated Value	316.145
	Confidence Interval	(2-Sided) 95%; 77.136 to 555.155
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 121.5971
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.011
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference in Least Squares Mean
	Estimated Value	313.119
	Confidence Interval	(2-Sided) 95%; 72.202 to 554.037
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 122.5676
	Estimation Comments

2. Secondary Outcome

Title	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.
Description	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 - 4 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Celecoxib	Diclofenac Test (Lower Dose)	Diclofenac Test (Upper Dose)	Placebo
Arm/Group Description	Celecoxib : 200 mg Capsules	Diclofenac Test (lower dose) : Capsules	Diclofenac Test (upper dose) : Capsules	Placebo : Capsules
Measure Participants	106	109	107	106
Mean (Standard Deviation) [mm*hour]	25.109 (62.9)	27.450 (64.9)	31.568 (68.6)	14.406 (53.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Diclofenac Test (Upper Dose), Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.043
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Diclofenac Test (Lower Dose), Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.109
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.183
	Comments
	Method	t-test, 2 sided
	Comments

3. Secondary Outcome

Title	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.
Description	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 - 8 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Celecoxib	Diclofenac Test (Lower Dose)	Diclofenac Test (Upper Dose)	Placebo
Arm/Group Description	Celecoxib : 200 mg Capsules	Diclofenac Test (lower dose) : Capsules	Diclofenac Test (upper dose) : Capsules	Placebo : Capsules
Measure Participants	106	109	107	106
Mean (Standard Deviation) [mm*hour]	51.675 (122.4)	56.404 (132.6)	64.689 (138.5)	23.151 (84.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Diclofenac Test (Upper Dose), Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.009
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Diclofenac Test (Lower Dose), Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.029
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.050
	Comments
	Method	t-test, 2 sided
	Comments

4. Secondary Outcome

Title	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.
Description	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 - 24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Celecoxib	Diclofenac Test (Lower Dose)	Diclofenac Test (Upper Dose)	Placebo
Arm/Group Description	Celecoxib : 200 mg Capsules	Diclofenac Test (lower dose) : Capsules	Diclofenac Test (upper dose) : Capsules	Placebo : Capsules
Measure Participants	106	109	107	106
Mean (Standard Deviation) [mm*hour]	170.845 (393.0)	177.101 (418.3)	230.708 (499.9)	48.811 (186.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Diclofenac Test (Upper Dose), Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Diclofenac Test (Lower Dose), Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.004
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.004
	Comments
	Method	t-test, 2 sided
	Comments

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Celecoxib	Diclofenac Test (Lower Dose)	Diclofenac Test (Upper Dose)	Placebo
Arm/Group Description	Celecoxib : 200 mg Capsules	Diclofenac Test (lower dose) : Capsules	Diclofenac Test (upper dose) : Capsules	Placebo : Capsules
Measure Participants	106	109	107	106
Mean (Standard Deviation) [units on a scale*hour]	2.226 (3.5)	2.112 (3.5)	2.530 (3.6)	1.387 (2.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Diclofenac Test (Upper Dose), Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.009
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Diclofenac Test (Lower Dose), Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.091
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.053
	Comments
	Method	t-test, 2 sided
	Comments

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Celecoxib	Diclofenac Test (Lower Dose)	Diclofenac Test (Upper Dose)	Placebo
Arm/Group Description	Celecoxib : 200 mg Capsules	Diclofenac Test (lower dose) : Capsules	Diclofenac Test (upper dose) : Capsules	Placebo : Capsules
Measure Participants	106	109	107	106
Mean (Standard Deviation) [units on a scale*hour]	3.840 (6.8)	3.690 (6.8)	4.652 (7.5)	1.943 (4.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Diclofenac Test (Upper Dose), Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Diclofenac Test (Lower Dose), Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.026
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.017
	Comments
	Method	t-test, 2 sided
	Comments

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Celecoxib	Diclofenac Test (Lower Dose)	Diclofenac Test (Upper Dose)	Placebo
Arm/Group Description	Celecoxib : 200 mg Capsules	Diclofenac Test (lower dose) : Capsules	Diclofenac Test (upper dose) : Capsules	Placebo : Capsules
Measure Participants	106	109	107	106
Mean (Standard Deviation) [units on a scale*hour]	10.670 (22.2595)	10.186 (21.3384)	13.325 (25.9326)	3.566 (10.8804)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Diclofenac Test (Upper Dose), Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Diclofenac Test (Lower Dose), Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.005
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.004
	Comments
	Method	t-test, 2 sided
	Comments

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Celecoxib	Diclofenac Test (Lower Dose)	Diclofenac Test (Upper Dose)	Placebo
Arm/Group Description	Celecoxib : 200 mg Capsules	Diclofenac Test (lower dose) : Capsules	Diclofenac Test (upper dose) : Capsules	Placebo : Capsules
Measure Participants	106	109	107	106
Mean (Standard Deviation) [units on a scale*hour]	22.972 (51.1)	21.635 (48.)	28.054 (58.1)	4.925 (19.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Diclofenac Test (Upper Dose), Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Diclofenac Test (Lower Dose), Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Arm/Group Title	Celecoxib		Diclofenac Test (Lower Dose)		Diclofenac Test (Upper Dose)		Placebo
Arm/Group Description	Celecoxib : 200 mg Capsules		Diclofenac Test (lower dose) : Capsules		Diclofenac Test (upper dose) : Capsules		Placebo : Capsules
All Cause Mortality
	Celecoxib		Diclofenac Test (Lower Dose)		Diclofenac Test (Upper Dose)		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Celecoxib		Diclofenac Test (Lower Dose)		Diclofenac Test (Upper Dose)		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/106 (0.9%)		0/109 (0%)		0/107 (0%)		0/106 (0%)
Vascular disorders
Deep vein thrombosis	1/106 (0.9%)	1	0/109 (0%)	0	0/107 (0%)	0	0/106 (0%)	0
Other (Not Including Serious) Adverse Events
	Celecoxib		Diclofenac Test (Lower Dose)		Diclofenac Test (Upper Dose)		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	86/106 (81.1%)		84/109 (77.1%)		77/107 (72%)		63/106 (59.4%)
Gastrointestinal disorders
Nausea	29/106 (27.4%)		34/109 (31.2%)		25/107 (23.4%)		39/106 (36.8%)
Vomiting	15/106 (14.2%)		13/109 (11.9%)		7/107 (6.5%)		13/106 (12.3%)
Constipation	9/106 (8.5%)		12/109 (11%)		6/107 (5.6%)		4/106 (3.8%)
Injury, poisoning and procedural complications
Postprocedural edema	35/106 (33%)		36/109 (33%)		35/107 (32.7%)		34/106 (32.1%)
Postprocedural hematoma	8/106 (7.5%)		12/109 (11%)		4/107 (3.7%)		11/106 (10.4%)
Nervous system disorders
Headache	11/106 (10.4%)		17/109 (15.6%)		11/107 (10.3%)		16/106 (15.1%)
Dizziness	11/106 (10.4%)		17/109 (15.6%)		5/107 (4.7%)		17/106 (16%)
Paraesthesia	8/106 (7.5%)		2/109 (1.8%)		2/107 (1.9%)		3/106 (2.8%)
Skin and subcutaneous tissue disorders
Pruritus	4/106 (3.8%)		4/109 (3.7%)		6/107 (5.6%)		4/106 (3.8%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.