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Study of Wafermine™ for Post-bunionectomy or Abdominoplasty Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03246971
Recruitment Status : Completed
First Posted : August 11, 2017
Last Update Posted : July 23, 2018
Sponsor:
Information provided by (Responsible Party):
iX Biopharma Ltd.

Tracking Information
First Submitted Date  ICMJE August 8, 2017
First Posted Date  ICMJE August 11, 2017
Last Update Posted Date July 23, 2018
Actual Study Start Date  ICMJE August 24, 2017
Actual Primary Completion Date July 12, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2017)		 Summed Pain Intensity Differences (SPID) using a Numerical Rating Scale [ Time Frame: 12 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Wafermine™ for Post-bunionectomy or Abdominoplasty Pain
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Pain
  • Bunion
  • Abdominoplasty
Intervention  ICMJE
  • 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  ICMJE
  • Experimental: Wafermine™
    Interventions:
    • Drug: Wafermine™ 50 mg
    • Drug: Wafermine™ 75 mg
    • Drug: Wafermine™ 25 mg
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebos
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 16, 2018)		 125
Original Estimated Enrollment  ICMJE
 (submitted: August 10, 2017)		 135
Actual Study Completion Date  ICMJE July 17, 2018
Actual Primary Completion Date July 12, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03246971
Other Study ID Numbers  ICMJE 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  ICMJE Not Provided
Current Responsible Party iX Biopharma Ltd.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE iX Biopharma Ltd.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account iX Biopharma Ltd.
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP