Study of Indomethacin Capsules to Treat Pain Following Bunionectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Iroko Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:
NCT01543685
First received: February 28, 2012
Last updated: January 2, 2014
Last verified: January 2014

February 28, 2012
January 2, 2014
February 2012
June 2012   (final data collection date for primary outcome measure)
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) [ Time Frame: 0 - 48 hours ] [ Designated as safety issue: No ]

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.

VAS summed pain intensity difference (VAS SPID) over 0 to 48 hours (VAS SPID-48) after Time 0 [ Time Frame: 0 - 48 hours ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01543685 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]

    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-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 ] [ Designated as safety issue: No ]

    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 [ Time Frame: 0 - 24 hours ] [ Designated as safety issue: No ]

    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 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.

  • Total Pain Relief (TOTPAR) Over 0 to 4 Hours (TOTPAR-4). [ Time Frame: 0 - 4 hours ] [ Designated as safety issue: No ]

    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.

  • TOTPAR-8. Total Pain Relief (TOTPAR) Over 0 to 8 Hours [ Time Frame: 0 - 8 hours ] [ Designated as safety issue: No ]

    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.

  • TOTPAR-24. Total Pain Relief (TOTPAR) Over 0 to 24 Hours [ Time Frame: 0 - 24 hours ] [ Designated as safety issue: No ]

    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 [ Time Frame: 0 - 48 hours ] [ Designated as safety issue: No ]

    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.

  • VAS pain intensity difference (VAS PID) at each scheduled time point up to 48 hours [ Time Frame: 0 - 48 hours ] [ Designated as safety issue: No ]
  • VAS pain intensity score at each scheduled time point [ Time Frame: 0 - 48 hours ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study of Indomethacin Capsules to Treat Pain Following Bunionectomy
A Phase 3, Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Active- and Placebo-Controlled Study of Indomethacin [Test] Capsules for the Treatment of Acute Postoperative Pain After Bunionectomy

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Other Acute Postoperative Pain
  • Drug: Indomethacin
    40 mg TID capsules
  • Drug: Indomethacin
    40 mg BID capsules
  • Drug: Indomethacin
    20 mg TID capsules
  • Drug: Celecoxib
    200 mg capsules
  • Drug: Placebo
    Capsules
  • Experimental: Indomethacin 40 mg TID
    Intervention: Drug: Indomethacin
  • Experimental: Indomethacin 40 mg BID
    Intervention: Drug: Indomethacin
  • Experimental: Indomethacin 20 mg TID
    Intervention: Drug: Indomethacin
  • Active Comparator: Celecoxib 200 mg
    Intervention: Drug: Celecoxib
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
462
July 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01543685
IND3-08-04b
No
Iroko Pharmaceuticals, LLC
Iroko Pharmaceuticals, LLC
Not Provided
Principal Investigator: Francis Clark, DPM Premier Research Group Limited
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
Iroko Pharmaceuticals, LLC
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP