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:
NCT01626118
First received: June 20, 2012
Last updated: February 17, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention Phase
Other Acute Postoperative Pain
Drug: Indomethacin
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Placebo-Controlled Study of Indomethacin Nanoformulation Capsules for the Treatment of Acute Postoperative Pain After Bunionectomy

Resource links provided by NLM:


Further study details as provided by Iroko Pharmaceuticals, LLC:

Primary Outcome 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 ] [ 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". Pain intensity is assessed at baseline (time "0") and at the following time points after time 0: 15, 30, and 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 32, 40, and 48 hours.

    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:
  • 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". Pain intensity is assessed at baseline (time "0") and at the following time points after time 0: 15, 30, and 45 minutes and 1, 1.5, 2, 3, and 4 hours.

    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". Pain intensity is assessed at baseline (time "0") and at the following time points after time 0: 15, 30, and 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 hours.

    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". Pain intensity is assessed at baseline (time "0") and at the following time points after time 0: 15, 30, and 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, and 24 hours.

    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 with a 5-point categorical scale at all assessment timepoints 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. Pain relief is assessed at the following points after time 0: 15, 30 & 45 minutes and 1, 1.5, 2, 3 & 4 hours.

    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. Thus, individual scores covering a longer period were given more weight. The minimum theoretical score is 0 units, which represents no pain relief (0 on scale) at all points after time 0. The maximum theoretical score is 16 units, which represents complete pain relief (4 on scale) at all points after 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 with a 5-point categorical scale at all assessment timepoints 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. Pain relief is assessed at the following points after time 0: 15, 30 & 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7 & 8 hours.

    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. Thus, individual scores covering a longer period were given more weight. The minimum theoretical score is 0 units, which represents no pain relief (0 on scale) at all points after time 0. The maximum theoretical score is 32 units, which represents complete pain relief (4 on scale) at all points after 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 with a 5-point categorical scale at all assessment timepoints 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. Pain relief is assessed at the following points after time 0: 15, 30 & 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, & 24 hours.

    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. Thus, individual scores covering a longer period were given more weight. The minimum theoretical score is 0 units, which represents no pain relief (0 on scale) at all points after time 0. The maximum theoretical score is 96 units, which represents complete pain relief (4 on scale) at all points after 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 with a 5-point categorical scale at all assessment timepoints 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. Pain relief is assessed at the following points after time 0: 15, 30 & 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 32, 40 & 48 hours.

    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. Thus, individual scores covering a longer period were given more weight. The minimum theoretical score is 0 units, which represents no pain relief (0 on scale) at all points after time 0. The maximum theoretical score is 192 units, which represents complete pain relief (4 on scale) at all points after 0.



Enrollment: 373
Study Start Date: May 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Indomethacin 40 mg TID Drug: Indomethacin
capsules, 40 mg, TID
Experimental: Indomethacin 40 mg BID Drug: Indomethacin
capsules, 40 mg, BID
Placebo Comparator: Placebo Drug: Placebo
capsules
Experimental: Indomethacin 20 mg TID Drug: Indomethacin
capsules, 20 mg, TID

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01626118

Locations
United States, Arizona
Premier Research Group Limited
Phoenix, Arizona, United States, 85027
United States, Maryland
Chesapeake Research Group, LLC
Pasadena, Maryland, United States, 21122
United States, Texas
Premier Research Group Limited
Austin, Texas, United States, 78705
United States, Utah
Premier Research Group Limited
Salt Lake City, Utah, United States, 84107
Sponsors and Collaborators
Iroko Pharmaceuticals, LLC
Investigators
Principal Investigator: Jason Dickerson, 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
  More Information

No publications provided

Responsible Party: Iroko Pharmaceuticals, LLC
ClinicalTrials.gov Identifier: NCT01626118     History of Changes
Other Study ID Numbers: IND3-10-06
Study First Received: June 20, 2012
Results First Received: December 11, 2013
Last Updated: February 17, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Indomethacin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cardiovascular Agents
Gout Suppressants
Tocolytic Agents
Reproductive Control Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 26, 2014