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NCT03246971 Clinical Trial

Study of Wafermine™ for Post-bunionectomy or Abdominoplasty Pain

Acute Pain Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03246971
Other study ID # KET010
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date August 24, 2017
Est. completion date July 17, 2018

Study information
Verified date July 2018
Source iX Biopharma Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 125
Est. completion date July 17, 2018
Est. primary completion date July 12, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Wafermine™ 50 mg
Administered as needed for 12 hours
• Wafermine™ 75 mg
Administered as needed for 12 hours
• Placebos
Administered as needed for 12 hours
• Wafermine™ 25 mg
Administered as needed for 12 hours

Locations
Country Name City State
United States Lotus Clinical Research Pasadena California

Sponsors (1)
Lead Sponsor Collaborator
iX Biopharma Ltd.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Summed Pain Intensity Differences (SPID) using a Numerical Rating Scale 12 hours
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