Title

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
  • Phase

    Phase 3
  • Study Type

    Interventional
  • Intervention/Treatment

    diclofenac celecoxib ...
  • Study Participants

    428
The purpose of this study is to determine whether Diclofenac [Test] Capsules are safe and effective for the treatment of bunionectomy pain.
Study Started
Oct 31
2011
Primary Completion
Feb 29
2012
Study Completion
Aug 31
2012
Results Posted
Dec 19
2013
Estimate
Last Update
Feb 04
2014
Estimate

Drug Placebo

Capsules

Drug Diclofenac Test (lower dose)

Capsules

Drug Diclofenac Test (upper dose)

Capsules

Drug Celecoxib

200 mg Capsules

Diclofenac Test (lower dose) Experimental

Diclofenac Test (upper dose) Experimental

Celecoxib Active Comparator

Placebo Placebo Comparator

Criteria

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

Summary

Celecoxib

Diclofenac Test (Lower Dose)

Diclofenac Test (Upper Dose)

Placebo

All Events

Event Type Organ System Event Term Celecoxib Diclofenac Test (Lower Dose) Diclofenac Test (Upper Dose) 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.

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.

Celecoxib

390.468
mm*hour (Mean)
Standard Deviation: 925.1

Diclofenac Test (Lower Dose)

392.954
mm*hour (Mean)
Standard Deviation: 937.0

Diclofenac Test (Upper Dose)

524.315
mm*hour (Mean)
Standard Deviation: 1146.1

Placebo

76.887
mm*hour (Mean)
Standard Deviation: 340.6

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.

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.

Celecoxib

25.109
mm*hour (Mean)
Standard Deviation: 62.9

Diclofenac Test (Lower Dose)

27.45
mm*hour (Mean)
Standard Deviation: 64.9

Diclofenac Test (Upper Dose)

31.568
mm*hour (Mean)
Standard Deviation: 68.6

Placebo

14.406
mm*hour (Mean)
Standard Deviation: 53.5

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.

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.

Celecoxib

51.675
mm*hour (Mean)
Standard Deviation: 122.4

Diclofenac Test (Lower Dose)

56.404
mm*hour (Mean)
Standard Deviation: 132.6

Diclofenac Test (Upper Dose)

64.689
mm*hour (Mean)
Standard Deviation: 138.5

Placebo

23.151
mm*hour (Mean)
Standard Deviation: 84.9

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.

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.

Celecoxib

170.845
mm*hour (Mean)
Standard Deviation: 393.0

Diclofenac Test (Lower Dose)

177.101
mm*hour (Mean)
Standard Deviation: 418.3

Diclofenac Test (Upper Dose)

230.708
mm*hour (Mean)
Standard Deviation: 499.9

Placebo

48.811
mm*hour (Mean)
Standard Deviation: 186.5

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.

Celecoxib

2.226
units on a scale*hour (Mean)
Standard Deviation: 3.5

Diclofenac Test (Lower Dose)

2.112
units on a scale*hour (Mean)
Standard Deviation: 3.5

Diclofenac Test (Upper Dose)

2.53
units on a scale*hour (Mean)
Standard Deviation: 3.6

Placebo

1.387
units on a scale*hour (Mean)
Standard Deviation: 2.7

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.

Celecoxib

3.84
units on a scale*hour (Mean)
Standard Deviation: 6.8

Diclofenac Test (Lower Dose)

3.69
units on a scale*hour (Mean)
Standard Deviation: 6.8

Diclofenac Test (Upper Dose)

4.652
units on a scale*hour (Mean)
Standard Deviation: 7.5

Placebo

1.943
units on a scale*hour (Mean)
Standard Deviation: 4.4

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.

Celecoxib

10.67
units on a scale*hour (Mean)
Standard Deviation: 22.2595

Diclofenac Test (Lower Dose)

10.186
units on a scale*hour (Mean)
Standard Deviation: 21.3384

Diclofenac Test (Upper Dose)

13.325
units on a scale*hour (Mean)
Standard Deviation: 25.9326

Placebo

3.566
units on a scale*hour (Mean)
Standard Deviation: 10.8804

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.

Diclofenac Test (Lower Dose)

21.635
units on a scale*hour (Mean)
Standard Deviation: 48.

Diclofenac Test (Upper Dose)

28.054
units on a scale*hour (Mean)
Standard Deviation: 58.1

Placebo

4.925
units on a scale*hour (Mean)
Standard Deviation: 19.4

Celecoxib

22.972
units on a scale*hour (Mean)
Standard Deviation: 51.1

Total

428
Participants

Age, Continuous

39.7
years (Mean)
Standard Deviation: 12.0

Region of Enrollment

Sex: Female, Male

Overall Study

Celecoxib

Diclofenac Test (Lower Dose)

Diclofenac Test (Upper Dose)

Placebo

Drop/Withdrawal Reasons

Celecoxib

Diclofenac Test (Upper Dose)

Placebo