Study of Wafermine™ for Post-bunionectomy or Abdominoplasty Pain

Sponsor

iX Biopharma Ltd. (Other)

Overall Status

Completed

CT.gov ID

NCT03246971

Collaborator

(none)

125

Enrollment

Location

Arms

10.7

Actual Duration (Months)

11.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Pain Bunion Abdominoplasty	Drug: Wafermine™ 50 mg Drug: Wafermine™ 75 mg Drug: Placebos Drug: Wafermine™ 25 mg	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

125 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Aug 24, 2017

Actual Primary Completion Date :

Jul 12, 2018

Actual Study Completion Date :

Jul 17, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Wafermine™	Drug: Wafermine™ 50 mg Administered as needed for 12 hours Drug: Wafermine™ 75 mg Administered as needed for 12 hours Drug: Wafermine™ 25 mg Administered as needed for 12 hours
Placebo Comparator: Placebo	Drug: Placebos Administered as needed for 12 hours

Arm

Intervention/Treatment

Experimental: Wafermine™

Drug: Wafermine™ 50 mg

Administered as needed for 12 hours

Drug: Wafermine™ 75 mg

Administered as needed for 12 hours

Drug: Wafermine™ 25 mg

Administered as needed for 12 hours

Placebo Comparator: Placebo

Drug: Placebos

Administered as needed for 12 hours

Outcome Measures

Primary Outcome Measures

Summed Pain Intensity Differences (SPID) using a Numerical Rating Scale [12 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lotus Clinical Research	Pasadena	California	United States	91105

Sponsors and Collaborators

iX Biopharma Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

iX Biopharma Ltd.

ClinicalTrials.gov Identifier:

NCT03246971

Other Study ID Numbers:

KET010

First Posted:

Aug 11, 2017

Last Update Posted:

Jul 23, 2018

Last Verified:

Jul 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Acute Pain

Study Results

No Results Posted as of Jul 23, 2018