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Study of Wafermine™ for Post-bunionectomy or Abdominoplasty Pain

Primary Purpose

Acute Pain, Bunion, Abdominoplasty

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Wafermine™ 50 mg
Wafermine™ 75 mg
Placebos
Wafermine™ 25 mg
Sponsored by
iX Biopharma Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Lotus Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Wafermine™

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Summed Pain Intensity Differences (SPID) using a Numerical Rating Scale

Secondary Outcome Measures

Full Information

First Posted
August 8, 2017
Last Updated
July 19, 2018
Sponsor
iX Biopharma Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03246971
Brief Title
Study of Wafermine™ for Post-bunionectomy or Abdominoplasty Pain
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
August 24, 2017 (Actual)
Primary Completion Date
July 12, 2018 (Actual)
Study Completion Date
July 17, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
iX Biopharma Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain, Bunion, Abdominoplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
125 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wafermine™
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Wafermine™ 50 mg
Intervention Description
Administered as needed for 12 hours
Intervention Type
Drug
Intervention Name(s)
Wafermine™ 75 mg
Intervention Description
Administered as needed for 12 hours
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
Administered as needed for 12 hours
Intervention Type
Drug
Intervention Name(s)
Wafermine™ 25 mg
Intervention Description
Administered as needed for 12 hours
Primary Outcome Measure Information:
Title
Summed Pain Intensity Differences (SPID) using a Numerical Rating Scale
Time Frame
12 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Lotus Clinical Research
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study of Wafermine™ for Post-bunionectomy or Abdominoplasty Pain

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