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

Completed · Phase 2 · Has a placebo group

Conditions studied: Acute Pain

In brief

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

Key facts

Study ID

NCT02541396

Run by

iX Biopharma Ltd.

People needed

72

Starts

2015-10-01

Expected to finish

2015-12-01

Last updated by the study team

2016-02-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Jean Brown Research — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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