Study of Wafermine™ for Post-bunionectomy or Abdominoplasty Pain

iX Biopharma

Status and phase: Completed; Phase 2

Conditions: Bunion; Acute Pain; Abdominoplasty

Treatments: Drug: Placebos; Drug: Wafermine™ 50 mg; Drug: Wafermine™ 25 mg; Drug: Wafermine™ 75 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT03246971

KET010

Details and patient eligibility

About

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.

Enrollment: 125 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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125 participants in 2 patient groups, including a placebo group

Wafermine™

Experimental group

Treatment:

Drug: Wafermine™ 75 mg

Drug: Wafermine™ 50 mg

Drug: Wafermine™ 25 mg

Placebo

Placebo Comparator group

Treatment:

Drug: Placebos