Skip to main content
OpenTrials
Completed

NCT Number: NCT03246971

Study of Wafermine™ for Post-bunionectomy or Abdominoplasty Pain

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Pain Abdominoplasty Bunion Foot Deformities Foot Deformities, Acquired Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Lotus Clinical Research

Pasadena, California, 91105, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Wafermine™ 50 mg

Drug

Administered as needed for 12 hours

Wafermine™ 75 mg

Drug

Administered as needed for 12 hours

Placebos

Drug

Administered as needed for 12 hours

Wafermine™ 25 mg

Drug

Administered as needed for 12 hours

Primary outcomes

  1. Summed Pain Intensity Differences (SPID) using a Numerical Rating Scale

    Time frame: 12 hours

Sponsors and collaborators

Lead sponsor

iX Biopharma Ltd.

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 11, 2017
Registry last updated
Jul 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.