Study of Wafermine™ for Post-bunionectomy or Abdominoplasty Pain

NCT03246971 — Phase 2, Completed, 125 participants, iX Biopharma Ltd.

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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

Registry	NCT03246971
Status	Completed
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	125 (Actual)
Sponsor	iX Biopharma Ltd. (Other)
Conditions	Acute Pain, Bunion, Abdominoplasty
Interventions	Wafermine™ 50 mg, Wafermine™ 75 mg, Placebos, Wafermine™ 25 mg (Drug)
Dates	start 2017-08-24, primary completion 2018-07-12, completion 2018-07-17, first posted 2017-08-11, last updated 2018-07-23
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Wafermine™	Experimental	Drug: Wafermine™ 50 mg; Drug: Wafermine™ 75 mg; Drug: Wafermine™ 25 mg
Placebo	Placebo comparator	Drug: Placebos

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

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to 75 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Lotus Clinical Research	Pasadena, California	United States

My Notes

Public

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