CompletedPhase 2Other
Study of Wafermine™ for Post-bunionectomy or Abdominoplasty Pain
Sponsored by iX Biopharma Ltd.
NCT ID
NCT03246971
Target Enrollment
125 participants
Start Date
2017-08-24
Est. Completion
2018-07-17
About This Study
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.
Conditions Studied
Interventions
- •Wafermine™ 50 mg
- •Wafermine™ 75 mg
- •Placebos
- •Wafermine™ 25 mg
Eligibility
Age:18 Years - 75 Years
Healthy Volunteers:Yes
View full 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
Study Locations (1)
Lotus Clinical Research
Pasadena, California, United States