Study of Indomethacin Capsules to Treat Pain Following Bunionectomy

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 2012

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: Indomethacin 40 mg TID
  • Experimental: Indomethacin 40 mg BID
  • Experimental: Indomethacin 20 mg TID
  • Active Comparator: Celecoxib 200 mg
  • Placebo Comparator: Placebo

Clinical Trial Outcome Measures

Primary Measures

  • 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
    • 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 Measures

  • 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
    • 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
    • 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
    • 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
    • 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
    • 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
    • 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
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Iroko Pharmaceuticals, LLC
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Francis Clark, DPM, Principal Investigator, Premier Research Group Limited
    • Michael Golf, DPM, Principal Investigator, Premier Research Group Limited
    • Ira Gottlieb, DPM, Principal Investigator, Chesapeake Research Group, LLC
    • Kyle Patrick, DO, Principal Investigator, Premier Research Group Limited

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