Study of Wafermine™ for Post-bunionectomy or Abdominoplasty Pain

July 19, 2018 updated by: iX Biopharma Ltd.

A Phase 2, Multiple-Dose Study of The Efficacy and Safety of Wafermine™ (Sublingual Ketamine) in Participants Experiencing Acute Post-Operative Bunionectomy or Abdominoplasty Pain

This study evaluates the safety and effectiveness of Wafermine™ for post-bunionectomy or post-abdominoplasty pain over a 24 hours period. For subjects undergoing bunionectomy, 2 out of 3 subjects will receive Wafermine™ and 1 out of 3 subjects will receive placebo. For subjects undergoing abdominoplasty, 3 out of 4 subjects will receive Wafermine™ and 1 out of 4 subjects will receive placebo.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

125

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Pasadena, California, United States, 91105
        • Lotus Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Scheduled for a bunionectomy or mini abdominoplasty with no additional planned procedures.
  • Good general health without clinically significant renal, hepatic, cardiac or respiratory disease, as determined by the Investigator.

Exclusion Criteria:

  • For those undergoing bunionectomy, other painful conditions involving the surgical foot.
  • Positive lab values for Hepatitis B or C or HIV

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebos
Administered as needed for 12 hours
Experimental: Wafermine™
Drug: Wafermine™ 50 mg
Administered as needed for 12 hours
Drug: Wafermine™ 75 mg
Administered as needed for 12 hours
Drug: Wafermine™ 25 mg
Administered as needed for 12 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Summed Pain Intensity Differences (SPID) using a Numerical Rating Scale
Time Frame: 12 hours
12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

iX Biopharma Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 24, 2017

Primary Completion (Actual)

July 12, 2018

Study Completion (Actual)

July 17, 2018

Study Registration Dates

First Submitted

August 8, 2017

First Submitted That Met QC Criteria

August 10, 2017

First Posted (Actual)

August 11, 2017

Study Record Updates

Last Update Posted (Actual)

July 23, 2018

Last Update Submitted That Met QC Criteria

July 19, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KET010

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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