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

NCT02541396 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2016-02-23

No results posted yet for this study

Summary

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

Conditions

  • Acute Pain

Interventions

DRUG

Wafermine

35 or 70 mg ketamine in a sublingual wafer

DRUG

Oxycodone

5 mg oxycodone capsule

DRUG

Placebo

Placebo capsule or placebo wafer

Sponsors & Collaborators

  • Jean Brown Research

    collaborator OTHER

  • iX Biopharma Ltd.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02541396 on ClinicalTrials.gov