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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02541396
Recruitment Status : Completed
First Posted : September 4, 2015
Last Update Posted : February 23, 2016
Sponsor:
Collaborator:
Jean Brown Research
Information provided by (Responsible Party):
iX Biopharma Ltd.

Tracking Information
First Submitted Date  ICMJE August 26, 2015
First Posted Date  ICMJE September 4, 2015
Last Update Posted Date February 23, 2016
Study Start Date  ICMJE October 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 3, 2015)
Total Pain Relief (TOTPAR) [ Time Frame: 24 hours ]
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]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 3, 2015)
  • Percent with maximum Pain Relief [ Time Frame: 24 hours ]
    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" [ Time Frame: 24 hours ]
    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 [ Time Frame: 24 hours ]
    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) [ Time Frame: 24 hours ]
    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 [ Time Frame: 24 hours ]
    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 [ Time Frame: 24 hours ]
    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 [ Time Frame: 24 hours ]
    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) [ Time Frame: 24 hours ]
    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) [ Time Frame: 24 hours ]
    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%) [ Time Frame: 24 hours ]
    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) [ Time Frame: 24 hours ]
    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) [ Time Frame: 24 hours ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Of The Effectiveness Of Wafermine Alone And In Combination With Opioids In Subjects Undergoing Bunionectomy
Official Title  ICMJE A Pilot Study Of The Efficacy Of WafermineTM Alone And In Combination With Opioids In Subjects Undergoing Bunionectomy
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acute Pain
Intervention  ICMJE
  • Drug: Wafermine
    35 or 70 mg ketamine in a sublingual wafer
    Other Name: Sublingual ketamine
  • Drug: Oxycodone
    5 mg oxycodone capsule
  • Drug: Placebo
    Placebo capsule or placebo wafer
Study Arms  ICMJE
  • Placebo Comparator: Group A
    Placebo wafers given every 2 hours Placebo capsule given every 4 hours Placebo wafers "top-up" dose given at hour 1
    Intervention: Drug: Placebo
  • Active Comparator: Group B
    Placebo wafers given every 2 hours Oxycodone given every 4 hours Placebo wafers "top-up" dose given at hour 1
    Intervention: Drug: Oxycodone
  • Experimental: Group C
    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
    Intervention: Drug: Wafermine
  • Experimental: Group D
    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
    Interventions:
    • Drug: Wafermine
    • Drug: Oxycodone
  • Experimental: Group E
    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
    Intervention: Drug: Wafermine
  • Experimental: Group F
    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
    Interventions:
    • Drug: Wafermine
    • Drug: Oxycodone
  • Experimental: Group G
    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: Drug: Wafermine
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: September 3, 2015)
72
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 NCT02541396
Other Study ID Numbers  ICMJE KET009
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party iX Biopharma Ltd.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE iX Biopharma Ltd.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Jean Brown Research
Investigators  ICMJE Not Provided
PRS Account iX Biopharma Ltd.
Verification Date February 2016

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