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Study of Indomethacin Capsules to Treat Pain Following Bunionectomy

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ClinicalTrials.gov Identifier: NCT01543685
Recruitment Status : Completed
First Posted : March 5, 2012
Results First Posted : December 19, 2013
Last Update Posted : February 4, 2014
Sponsor:
Information provided by (Responsible Party):
Iroko Pharmaceuticals, LLC

Tracking Information
First Submitted Date  ICMJE February 28, 2012
First Posted Date  ICMJE March 5, 2012
Results First Submitted Date  ICMJE February 27, 2013
Results First Posted Date  ICMJE December 19, 2013
Last Update Posted Date February 4, 2014
Study Start Date  ICMJE February 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 21, 2013)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 2, 2012)
VAS summed pain intensity difference (VAS SPID) over 0 to 48 hours (VAS SPID-48) after Time 0 [ Time Frame: 0 - 48 hours ]
Change History Complete list of historical versions of study NCT01543685 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 2, 2014)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2012)
  • VAS pain intensity difference (VAS PID) at each scheduled time point up to 48 hours [ Time Frame: 0 - 48 hours ]
  • VAS pain intensity score at each scheduled time point [ Time Frame: 0 - 48 hours ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Indomethacin Capsules to Treat Pain Following Bunionectomy
Official Title  ICMJE 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
Brief Summary The purpose of this study is to determine whether Indomethacin [Test] Capsules are safe and effective for the treatment of postoperative bunionectomy pain.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Other Acute Postoperative Pain
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 21, 2013)
462
Original Estimated Enrollment  ICMJE
 (submitted: March 2, 2012)
460
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01543685
Other Study ID Numbers  ICMJE IND3-08-04b
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Iroko Pharmaceuticals, LLC
Study Sponsor  ICMJE Iroko Pharmaceuticals, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Iroko Pharmaceuticals, LLC
Verification Date January 2014

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