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Study of Wafermine™ for Post-bunionectomy or Abdominoplasty Pain

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03246971
Enrollment
125
Registered
2017-08-11
Start date
2017-08-24
Completion date
2018-07-17
Last updated
2018-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominoplasty, Acute Pain, Bunion

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.

Interventions

DRUGWafermine™ 50 mg

Administered as needed for 12 hours

DRUGWafermine™ 75 mg

Administered as needed for 12 hours

DRUGPlacebos

Administered as needed for 12 hours

DRUGWafermine™ 25 mg

Administered as needed for 12 hours

Sponsors

iX Biopharma Ltd.
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
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

Design outcomes

Primary

MeasureTime frame
Summed Pain Intensity Differences (SPID) using a Numerical Rating Scale12 hours

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026