A Study Of The Effectiveness Of Wafermine Alone And In Combination With Opioids In Subjects Undergoing Bunionectomy
Acute Pain
About this trial
This is an interventional treatment trial for Acute Pain focused on measuring Bunion, Bunionectomy
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.
Sites / Locations
- Jean Brown Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Placebo Comparator
Active Comparator
Experimental
Experimental
Experimental
Experimental
Experimental
Group A
Group B
Group C
Group D
Group E
Group F
Group G
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