CompletedPhase 2Other

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

Sponsored by iX Biopharma Ltd.

NCT ID
NCT02541396
Target Enrollment
72 participants
Start Date
2015-10
Est. Completion
2015-12

About This Study

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

Conditions Studied

Acute Pain

Interventions

  • Wafermine
  • Oxycodone
  • Placebo

Eligibility

Age:18 Years - N/A
Healthy Volunteers:No
View full 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.

Study Locations (1)

Jean Brown Research
Salt Lake City, Utah, United States

This trial is not recruiting

This study has completed enrollment. Check back for results or find similar trials.

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Data Source
ClinicalTrials.gov

Last updated from source