Study of Wafermine™ for Post-bunionectomy or Abdominoplasty Pain
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ClinicalTrials.gov Identifier: NCT03246971 |
Recruitment Status :
Completed
First Posted : August 11, 2017
Last Update Posted : July 23, 2018
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Sponsor:
iX Biopharma Ltd.
Information provided by (Responsible Party):
iX Biopharma Ltd.
Tracking Information | |||||
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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 |
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 |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
125 | ||||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |