NCT03246971

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: iX Biopharma Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Acute Pain
• Bunion
• Abdominoplasty

Interventions

Type	Name	Description
DRUG	Wafermine™ 50 mg	Administered as needed for 12 hours
DRUG	Wafermine™ 75 mg	Administered as needed for 12 hours
DRUG	Placebos	Administered as needed for 12 hours
DRUG	Wafermine™ 25 mg	Administered as needed for 12 hours

Timeline

• Start date: 2017-08-24
• Primary completion: 2018-07-12
• Completion: 2018-07-17
• First posted: 2017-08-11
• Last updated: 2018-07-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study