Expired Study
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Salt Lake City, Utah 84124


Purpose:

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


Study summary:

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.


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.


NCT ID:

NCT02541396


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Salt Lake City, Utah 84124
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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