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A Study Of The Effectiveness Of Wafermine Alone And In Combination With Opioids In Subjects Undergoing Bunionectomy

Primary Purpose

Acute Pain

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Wafermine
Oxycodone
Placebo
Sponsored by
iX Biopharma Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pain focused on measuring Bunion, Bunionectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Scheduled for a bunionectomy (with no additional procedures).
  • Healthy, ambulatory subjects able to understand and willing to comply with study procedures, study restrictions and requirements.
  • Body mass index (BMI) ≥19 to ≤33 kg/m2.
  • Females: Not pregnant, not lactating, and not planning to become pregnant during the study.
  • Females: Be abstinent, surgically sterile, at least two years post-menopausal; or medically acceptable contraception.
  • Able to read and understand English.
  • Able to swallow oral capsules whole.

Exclusion Criteria:

  • Allergy, intolerance, or contraindication to ketamine, oxycodone, morphine, ibuprofen or surgical medications.
  • Clinically significant medical condition.
  • History of illicit drug use or alcohol abuse and not in full remission.
  • Positive test for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) at the screening visit.
  • Clinically significant 12 lead ECG abnormalities at screening.
  • Smokers who are unwilling to abstain during the inpatient stay.

Sites / Locations

  • Jean Brown Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Placebo Comparator

Active Comparator

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Group A

Group B

Group C

Group D

Group E

Group F

Group G

Arm Description

Placebo wafers given every 2 hours Placebo capsule given every 4 hours Placebo wafers "top-up" dose given at hour 1

Placebo wafers given every 2 hours Oxycodone given every 4 hours Placebo wafers "top-up" dose given at hour 1

Wafermine™ 35 mg wafer + placebo wafer given every 2 hours Placebo capsule given every 4 hours Wafermine™ 35 mg wafer + placebo wafer "top-up" dose at hour 1

Wafermine™ 35 mg wafer + placebo wafer given every 2 hours Oxycodone 5 mg capsule every 4 hours Wafermine™ 35 mg "wafer + placebo wafer top-up" dose at hour 1

Wafermine™ 35 mg + placebo wafer given every 4 hours Placebo wafers given every 2 hours Placebo capsule given every 4 hours Wafermine™ 35 mg wafer + placebo wafer "top-up" dose at hour 1

Wafermine™ 35 mg + placebo wafer given every 4 hours Placebo wafers given every 2 hours Oxycodone 5 mg given every 4 hours Wafermine™ 35 mg wafer + placebo wafer "top-up" dose at hour 1

Wafermine™ 70 mg given every 4 hours Placebo wafer given every 2 hours Placebo capsule given every 4 hours 2 Placebo wafers "top-up" dose at hour 1

Outcomes

Primary Outcome Measures

Total Pain Relief (TOTPAR)
Subjects will use an 11 point numerical pain rating scale (NPRS) where 0=No Pain and 10= Worst Possible pain to rate their pain at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.5, 13, 13.5, 14, 14.5, 15, 15.5, 16 and 24 hours. TOTPAR is computed as follows at the specified time points: TOTPAR-t = ∑ [T(i) - T(i-1) * [(PR(i-1) + PR(i))/2]

Secondary Outcome Measures

Percent with maximum Pain Relief
The percent of maximum pain relief is defined as the proportion of subjects reporting "Complete Relief" (score of 4) on a 4 point categorical scale (no relief, a little relief, some relief, a lot of relief and complete relief) at each time point over the sampling interval.
Proportion of Subjects requiring "Rescue Medication"
Calculation of the proportion of subjects requiring "Rescue Medication" at each time point over the sampling interval.
Time to onset of perceptible and meaningful pain relief
Calculated using the double stopwatch technique. Subjects stop the first stopwatch when they experience perceptible relief and the second stopwatch when they experience meaningful relief.
Time to onset of complete pain relief (Peak Relief)
Measurement of the time it takes subjects to report their maximum pain relief on a 5 point categorical relief scale (0=no relief, 1=a little relief, 2=some relief, 3=a lot of relief, 4=complete relief)
Time to maximum reduction in pain intensity
Measurement of the time it takes subjects to reach their maximum reduction in pain on the 11 point NPRS where 0=No pain and 10=Worst Possible pain.
Time for pain intensity to return to baseline
Measurement of the time for pain intensity to return to baseline using scores from the NPRS assessments where 0=No pain and 10=Worst possible pain.
Time to rescue medication
Measurement of the time elapsed from initial dose of study medication to time of first dose of rescue medication.
Percentage of Maximum Total Pain Relief (TOTPAR)
Subjects will use an 11 point numerical pain rating scale (NPRS) where 0=No Pain and 10= Worst Possible pain to rate their pain at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.5, 13, 13.5, 14, 14.5, 15, 15.5, 16 and 24 hours. Percentage of Maximum Total Pain Relief is computed at each time-point using: %maxTOTPAR= 〖TOTPAR〗_t/〖maxTOTPAR〗_t x100
Sum of Pain Intensity Differences (SPID)
Subjects will use an 11 point numerical pain rating scale (NPRS) where 0-No Pain and 10= Worst Possible pain to rate their pain at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.5, 13, 13.5, 14, 14.5, 15, 15.5, 16 and 24 hours. Sum of Pain Intensity Differences is computed at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.5, 13, 13.5, 14, 14.5, 15, 15.5, 16 and 24 hours. SPIDx is a time weighted sum of pain intensity difference score from baseline over the time interval in hours.
Responder Rates (30% and 50%)
The responder rate is defined as the proportion of subjects with a value of percentage change greater than or equal to 30% (and 50%) from baseline in pain intensity (using scores from the 11 point NPRS where 0=no pain and 10=worst possible pain) at each time point over the sampling interval.
Safety (treatment emergent adverse events, significant changes in physical examination findings as well as vital sign measurements)
Measurement of treatment emergent adverse events reported during the study. Measurement of significant changes in physical examination findings as well as vital sign measurements (heart rate, blood pressure, breathing rate and pulse oximetry readings).
Tolerability (judged by subject answers on oral symptoms questionnaire)
Measurement of tolerability as judged by subject answers on oral symptoms questionnaire measuring irritation, burning and bitterness, as well as physical examination of oral cavity. Also measuring the number of subjects who discontinue the study due to intolerable side effects.

Full Information

First Posted
August 26, 2015
Last Updated
February 22, 2016
Sponsor
iX Biopharma Ltd.
Collaborators
Jean Brown Research
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1. Study Identification

Unique Protocol Identification Number
NCT02541396
Brief Title
A Study Of The Effectiveness Of Wafermine Alone And In Combination With Opioids In Subjects Undergoing Bunionectomy
Official Title
A Pilot Study Of The Efficacy Of WafermineTM Alone And In Combination With Opioids In Subjects Undergoing Bunionectomy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
iX Biopharma Ltd.
Collaborators
Jean Brown Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To evaluate the safety and effectiveness of Wafermine administered with and without an opioid medication for acute pain following bunionectomy surgery.
Detailed Description
This is a Phase 2, randomised, double-blind, double-dummy, placebo-controlled evaluation of the analgesic efficacy and safety of WafermineTM alone and in combination with low-dose oxycodone in adult subjects who experience post-operative pain after undergoing primary unilateral bunionectomy. The study will randomise sufficient subjects to have 72 completed subjects at 1 site. Study subjects will receive multiple doses of study medication over a 14 hour period and will be asked to complete pain and relief assessments as well as tolerability questionnaires over a 24 hour period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain
Keywords
Bunion, Bunionectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Placebo Comparator
Arm Description
Placebo wafers given every 2 hours Placebo capsule given every 4 hours Placebo wafers "top-up" dose given at hour 1
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Placebo wafers given every 2 hours Oxycodone given every 4 hours Placebo wafers "top-up" dose given at hour 1
Arm Title
Group C
Arm Type
Experimental
Arm Description
Wafermine™ 35 mg wafer + placebo wafer given every 2 hours Placebo capsule given every 4 hours Wafermine™ 35 mg wafer + placebo wafer "top-up" dose at hour 1
Arm Title
Group D
Arm Type
Experimental
Arm Description
Wafermine™ 35 mg wafer + placebo wafer given every 2 hours Oxycodone 5 mg capsule every 4 hours Wafermine™ 35 mg "wafer + placebo wafer top-up" dose at hour 1
Arm Title
Group E
Arm Type
Experimental
Arm Description
Wafermine™ 35 mg + placebo wafer given every 4 hours Placebo wafers given every 2 hours Placebo capsule given every 4 hours Wafermine™ 35 mg wafer + placebo wafer "top-up" dose at hour 1
Arm Title
Group F
Arm Type
Experimental
Arm Description
Wafermine™ 35 mg + placebo wafer given every 4 hours Placebo wafers given every 2 hours Oxycodone 5 mg given every 4 hours Wafermine™ 35 mg wafer + placebo wafer "top-up" dose at hour 1
Arm Title
Group G
Arm Type
Experimental
Arm Description
Wafermine™ 70 mg given every 4 hours Placebo wafer given every 2 hours Placebo capsule given every 4 hours 2 Placebo wafers "top-up" dose at hour 1
Intervention Type
Drug
Intervention Name(s)
Wafermine
Other Intervention Name(s)
Sublingual ketamine
Intervention Description
35 or 70 mg ketamine in a sublingual wafer
Intervention Type
Drug
Intervention Name(s)
Oxycodone
Intervention Description
5 mg oxycodone capsule
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo capsule or placebo wafer
Primary Outcome Measure Information:
Title
Total Pain Relief (TOTPAR)
Description
Subjects will use an 11 point numerical pain rating scale (NPRS) where 0=No Pain and 10= Worst Possible pain to rate their pain at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.5, 13, 13.5, 14, 14.5, 15, 15.5, 16 and 24 hours. TOTPAR is computed as follows at the specified time points: TOTPAR-t = ∑ [T(i) - T(i-1) * [(PR(i-1) + PR(i))/2]
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Percent with maximum Pain Relief
Description
The percent of maximum pain relief is defined as the proportion of subjects reporting "Complete Relief" (score of 4) on a 4 point categorical scale (no relief, a little relief, some relief, a lot of relief and complete relief) at each time point over the sampling interval.
Time Frame
24 hours
Title
Proportion of Subjects requiring "Rescue Medication"
Description
Calculation of the proportion of subjects requiring "Rescue Medication" at each time point over the sampling interval.
Time Frame
24 hours
Title
Time to onset of perceptible and meaningful pain relief
Description
Calculated using the double stopwatch technique. Subjects stop the first stopwatch when they experience perceptible relief and the second stopwatch when they experience meaningful relief.
Time Frame
24 hours
Title
Time to onset of complete pain relief (Peak Relief)
Description
Measurement of the time it takes subjects to report their maximum pain relief on a 5 point categorical relief scale (0=no relief, 1=a little relief, 2=some relief, 3=a lot of relief, 4=complete relief)
Time Frame
24 hours
Title
Time to maximum reduction in pain intensity
Description
Measurement of the time it takes subjects to reach their maximum reduction in pain on the 11 point NPRS where 0=No pain and 10=Worst Possible pain.
Time Frame
24 hours
Title
Time for pain intensity to return to baseline
Description
Measurement of the time for pain intensity to return to baseline using scores from the NPRS assessments where 0=No pain and 10=Worst possible pain.
Time Frame
24 hours
Title
Time to rescue medication
Description
Measurement of the time elapsed from initial dose of study medication to time of first dose of rescue medication.
Time Frame
24 hours
Title
Percentage of Maximum Total Pain Relief (TOTPAR)
Description
Subjects will use an 11 point numerical pain rating scale (NPRS) where 0=No Pain and 10= Worst Possible pain to rate their pain at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.5, 13, 13.5, 14, 14.5, 15, 15.5, 16 and 24 hours. Percentage of Maximum Total Pain Relief is computed at each time-point using: %maxTOTPAR= 〖TOTPAR〗_t/〖maxTOTPAR〗_t x100
Time Frame
24 hours
Title
Sum of Pain Intensity Differences (SPID)
Description
Subjects will use an 11 point numerical pain rating scale (NPRS) where 0-No Pain and 10= Worst Possible pain to rate their pain at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.5, 13, 13.5, 14, 14.5, 15, 15.5, 16 and 24 hours. Sum of Pain Intensity Differences is computed at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.5, 13, 13.5, 14, 14.5, 15, 15.5, 16 and 24 hours. SPIDx is a time weighted sum of pain intensity difference score from baseline over the time interval in hours.
Time Frame
24 hours
Title
Responder Rates (30% and 50%)
Description
The responder rate is defined as the proportion of subjects with a value of percentage change greater than or equal to 30% (and 50%) from baseline in pain intensity (using scores from the 11 point NPRS where 0=no pain and 10=worst possible pain) at each time point over the sampling interval.
Time Frame
24 hours
Title
Safety (treatment emergent adverse events, significant changes in physical examination findings as well as vital sign measurements)
Description
Measurement of treatment emergent adverse events reported during the study. Measurement of significant changes in physical examination findings as well as vital sign measurements (heart rate, blood pressure, breathing rate and pulse oximetry readings).
Time Frame
24 hours
Title
Tolerability (judged by subject answers on oral symptoms questionnaire)
Description
Measurement of tolerability as judged by subject answers on oral symptoms questionnaire measuring irritation, burning and bitterness, as well as physical examination of oral cavity. Also measuring the number of subjects who discontinue the study due to intolerable side effects.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Scheduled for a bunionectomy (with no additional procedures). Healthy, ambulatory subjects able to understand and willing to comply with study procedures, study restrictions and requirements. Body mass index (BMI) ≥19 to ≤33 kg/m2. Females: Not pregnant, not lactating, and not planning to become pregnant during the study. Females: Be abstinent, surgically sterile, at least two years post-menopausal; or medically acceptable contraception. Able to read and understand English. Able to swallow oral capsules whole. Exclusion Criteria: Allergy, intolerance, or contraindication to ketamine, oxycodone, morphine, ibuprofen or surgical medications. Clinically significant medical condition. History of illicit drug use or alcohol abuse and not in full remission. Positive test for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) at the screening visit. Clinically significant 12 lead ECG abnormalities at screening. Smokers who are unwilling to abstain during the inpatient stay.
Facility Information:
Facility Name
Jean Brown Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Study Of The Effectiveness Of Wafermine Alone And In Combination With Opioids In Subjects Undergoing Bunionectomy

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