Study of Wafermine™ for Post-bunionectomy or Abdominoplasty Pain

Phase 2

Completed

• Conditions: Abdominoplasty; Acute Pain; Bunion
• Interventions: Drug: Placebos; Drug: Wafermine™ 50 mg; Drug: Wafermine™ 75 mg; Drug: Wafermine™ 25 mg

• Registration Number: NCT03246971
• Lead Sponsor: iX Biopharma Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-08
• Study First Submitted QC: 2017-08-10
• Study First Posted: 2017-08-11
• Study Start: 2017-08-24
• Status Verified: 2018-07
• Primary Completion: 2018-07-12
• Study Completion: 2018-07-17
• Last Update Submitted: 2018-07-19
• Last Update Posted: 2018-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wafermine™	Wafermine™ 25 mg	-
Placebo	Placebos	-
Wafermine™	Wafermine™ 50 mg	-
Wafermine™	Wafermine™ 75 mg	-

Primary Outcome Measures

Name	Time	Method
Summed Pain Intensity Differences (SPID) using a Numerical Rating Scale	12 hours

Trial Locations

Locations (1)

Lotus Clinical Research; 🇺🇸 Pasadena, California, United States