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Study of Wafermine™ for Post-bunionectomy or Abdominoplasty Pain

NCT03246971 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2018-07-23

No results posted yet for this study

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

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

Sponsors & Collaborators

  • iX Biopharma Ltd.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-24
Primary Completion
2018-07-12
Completion
2018-07-17
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03246971 on ClinicalTrials.gov