Study of Wafermine™ for Post-bunionectomy or Abdominoplasty Pain

Ketamine

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.

Intervention / Treatment

  • Wafermine™ 50 mg (DRUG)
    Administered as needed for 12 hours
  • Wafermine™ 75 mg (DRUG)
    Administered as needed for 12 hours
  • Placebos (DRUG)
    Administered as needed for 12 hours
  • Wafermine™ 25 mg (DRUG)
    Administered as needed for 12 hours

Condition or Disease

  • Acute Pain
  • Bunion
  • Abdominoplasty

Phase

  • Phase 2

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 75 Years
    Enrollment: 125 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Aug 24, 2017 ACTUAL
    Primary Completion: Jul 12, 2018 ACTUAL
    Completion Date: Jul 17, 2018 ACTUAL
    Study First Posted: Aug 11, 2017 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Jul 19, 2018

    Sponsors / Collaborators

    Lead Sponsor: iX Biopharma Ltd.
    Lead sponsor is responsible party
    Responsible Party: N/A

    Location

    Pasadena, California, USA

    Participant Groups

    • No description provided

    • No description provided

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 75
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes
    • Summed Pain Intensity Differences (SPID) using a Numerical Rating Scale 12 hours

    More Details

    NCT Number: NCT03246971
    Other IDs: KET010
    Study URL: https://clinicaltrials.gov/study/NCT03246971
    Last updated: Sep 29, 2023