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

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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.

Brief Summary:
To evaluate the safety and effectiveness of Wafermine administered with and without an opioid medication for acute pain following bunionectomy surgery.

Condition or disease Intervention/treatment Phase
Acute Pain Drug: Wafermine Drug: Oxycodone Drug: Placebo Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Study Of The Efficacy Of WafermineTM Alone And In Combination With Opioids In Subjects Undergoing Bunionectomy
Study Start Date : October 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Drug: Placebo
Placebo capsule or placebo wafer

Active Comparator: Group B
Placebo wafers given every 2 hours Oxycodone given every 4 hours Placebo wafers "top-up" dose given at hour 1
Drug: Oxycodone
5 mg oxycodone capsule

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
Drug: Wafermine
35 or 70 mg ketamine in a sublingual wafer
Other Name: Sublingual ketamine

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
Drug: Wafermine
35 or 70 mg ketamine in a sublingual wafer
Other Name: Sublingual ketamine

Drug: Oxycodone
5 mg oxycodone capsule

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
Drug: Wafermine
35 or 70 mg ketamine in a sublingual wafer
Other Name: Sublingual ketamine

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
Drug: Wafermine
35 or 70 mg ketamine in a sublingual wafer
Other Name: Sublingual ketamine

Drug: Oxycodone
5 mg oxycodone capsule

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
Drug: Wafermine
35 or 70 mg ketamine in a sublingual wafer
Other Name: Sublingual ketamine




Primary Outcome Measures :
  1. 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]



Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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)

  5. 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.

  6. 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.

  7. 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.

  8. 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


  9. 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.


  10. 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.

  11. 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).

  12. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02541396


Locations
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United States, Utah
Jean Brown Research
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
iX Biopharma Ltd.
Jean Brown Research

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Responsible Party: iX Biopharma Ltd.
ClinicalTrials.gov Identifier: NCT02541396     History of Changes
Other Study ID Numbers: KET009
First Posted: September 4, 2015    Key Record Dates
Last Update Posted: February 23, 2016
Last Verified: February 2016

Keywords provided by iX Biopharma Ltd.:
Bunion
Bunionectomy

Additional relevant MeSH terms:
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Central Nervous System Depressants
Acute Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Ketamine
Oxycodone
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics