Study of Wafermine™ for Post-bunionectomy or Abdominoplasty Pain

iX Biopharma Ltd.125 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

125

Conditions

Acute Pain Bunion Abdominoplasty

Interventions

Wafermine™ 50 mgDRUG

Administered as needed for 12 hours

Wafermine™ 75 mgDRUG

Administered as needed for 12 hours

PlacebosDRUG

Administered as needed for 12 hours

Wafermine™ 25 mg

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Lotus Clinical Research

Pasadena, California, United States

Outcomes

Primary Outcomes

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

Time frame: 12 hours

Data from ClinicalTrials.gov

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