Clinical trial NCT02541396: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Pain
Keywords: Bunion
Bunionectomy
Lead sponsor: iX Biopharma Ltd.
Sponsor class: OTHER
Collaborators: name: Jean Brown Research
First posted: 2015-09-04
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Total Pain Relief (TOTPAR)
timeFrame: 24 hours
Secondary outcomes:
measure: Percent with maximum Pain Relief
timeFrame: 24 hours
measure: Proportion of Subjects requiring "Rescue Medication"
timeFrame: 24 hours
measure: Time to onset of perceptible and meaningful pain relief
timeFrame: 24 hours
measure: Time to onset of complete pain relief (Peak Relief)
timeFrame: 24 hours
measure: Time to maximum reduction in pain intensity
timeFrame: 24 hours
measure: Time for pain intensity to return to baseline
timeFrame: 24 hours
measure: Time to rescue medication
timeFrame: 24 hours
measure: Percentage of Maximum Total Pain Relief (TOTPAR)
timeFrame: 24 hours
measure: Sum of Pain Intensity Differences (SPID)
timeFrame: 24 hours
measure: Responder Rates (30% and 50%)
timeFrame: 24 hours
measure: Safety (treatment emergent adverse events, significant changes in physical examination findings as well as vital sign measurements)
timeFrame: 24 hours
measure: Tolerability (judged by subject answers on oral symptoms questionnaire)
timeFrame: 24 hours
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Jean Brown Research
state: Utah
Study officials:
References: