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

Acute Pain Clinical Trial

Official title:

A Pilot Study Of The Efficacy Of WafermineTM Alone And In Combination With Opioids In Subjects Undergoing Bunionectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02541396
• Other study ID #: KET009
• Status: Completed
• Phase: Phase 2
• First received: August 26, 2015
• Last updated: February 22, 2016
• Start date: October 2015
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: iX Biopharma Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Pain

Intervention

Drug:
• Wafermine
35 or 70 mg ketamine in a sublingual wafer
• Oxycodone
5 mg oxycodone capsule
• Placebo
Placebo capsule or placebo wafer

Locations

Country	Name	City	State
United States	Jean Brown Research	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
iX Biopharma Ltd.	Jean Brown Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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]	24 hours	No
Secondary	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.	24 hours	No
Secondary	Proportion of Subjects requiring "Rescue Medication"	Calculation of the proportion of subjects requiring "Rescue Medication" at each time point over the sampling interval.	24 hours	No
Secondary	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.	24 hours	No
Secondary	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)	24 hours	No
Secondary	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.	24 hours	No
Secondary	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.	24 hours	No
Secondary	Time to rescue medication	Measurement of the time elapsed from initial dose of study medication to time of first dose of rescue medication.	24 hours	No
Secondary	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	24 hours	No
Secondary	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.	24 hours	No
Secondary	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.	24 hours	Yes
Secondary	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).	24 hours	Yes
Secondary	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.	24 hours	No