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

iX Biopharma

Status and phase

Completed

Phase 2

Conditions

Acute Pain

Treatments

Drug: Oxycodone

Drug: Placebo

Drug: Wafermine

Study type

Interventional

Funder types

Other

Identifiers

NCT02541396

KET009

Details and patient eligibility

About

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

Full description

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.

Enrollment

72 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

72 participants in 7 patient groups, including a placebo group

Group A

Placebo Comparator group

Description:

Placebo wafers given every 2 hours Placebo capsule given every 4 hours Placebo wafers "top-up" dose given at hour 1

Treatment:

Drug: Placebo

Group B

Active Comparator group

Description:

Placebo wafers given every 2 hours Oxycodone given every 4 hours Placebo wafers "top-up" dose given at hour 1

Treatment:

Drug: Oxycodone

Group C

Experimental group

Description:

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

Treatment:

Drug: Wafermine

Group D

Experimental group

Description:

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

Treatment:

Drug: Wafermine

Drug: Oxycodone

Group E

Experimental group

Description:

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

Treatment:

Drug: Wafermine

Group F

Experimental group

Description:

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

Treatment:

Drug: Wafermine

Drug: Oxycodone

Group G

Experimental group

Description:

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

Treatment:

Drug: Wafermine