Study of Wafermine™ for Post-bunionectomy or Abdominoplasty Pain

• ClinicalTrials.gov Identifier: NCT03246971
• Recruitment Status: Completed
• First Posted: August 11, 2017
• Last Update Posted: July 23, 2018
• Sponsor: iX Biopharma Ltd.
• Information provided by (Responsible Party): iX Biopharma Ltd.

Tracking Information

• First Submitted Date: August 8, 2017
• First Posted Date: August 11, 2017
• Last Update Posted Date: July 23, 2018
• Actual Study Start Date: August 24, 2017
• Actual Primary Completion Date: July 12, 2018 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: August 10, 2017): Summed Pain Intensity Differences (SPID) using a Numerical Rating Scale [ Time Frame: 12 hours ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study of Wafermine™ for Post-bunionectomy or Abdominoplasty Pain
• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Acute Pain
• Bunion
• Abdominoplasty

Intervention

• 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

Study Arms

• Experimental: Wafermine™
  Interventions:

  • Drug: Wafermine™ 50 mg
  • Drug: Wafermine™ 75 mg
  • Drug: Wafermine™ 25 mg
• Placebo Comparator: Placebo
  Intervention: Drug: Placebos

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 16, 2018): 125
• Original Estimated Enrollment (submitted: August 10, 2017): 135
• Actual Study Completion Date: July 17, 2018
• Actual Primary Completion Date: July 12, 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03246971
• Other Study ID Numbers: KET010
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: iX Biopharma Ltd.
• Study Sponsor: iX Biopharma Ltd.
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: iX Biopharma Ltd.
• Verification Date: July 2018