Study of Wafermine™ for Post-bunionectomy or Abdominoplasty Pain

Completed · Phase 2 · Has a placebo group

Conditions studied: Acute Pain, Bunion, Abdominoplasty

In brief

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.

Key facts

Study ID

NCT03246971

Run by

iX Biopharma Ltd.

People needed

125

Starts

2017-08-24

Expected to finish

2018-07-17

Last updated by the study team

2018-07-23

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• For those undergoing bunionectomy, other painful conditions involving the surgical foot.
• Positive lab values for Hepatitis B or C or HIV

Where it is running

• Lotus Clinical Research — Pasadena, California, United States

Full record on ClinicalTrials.gov

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