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



Status:Completed
Conditions:Chronic Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:October 2015
End Date:December 2015

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

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

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.

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.
We found this trial at
1
site
1045 East 3900 South
Salt Lake City, Utah 84124
801-261-2000
?
mi
from
Salt Lake City, UT
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