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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.

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

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Study Type : Interventional  (Clinical Trial)
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 : August 24, 2017
Actual Primary Completion Date : July 12, 2018
Actual Study Completion Date : July 17, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Summed Pain Intensity Differences (SPID) using a Numerical Rating Scale [ Time Frame: 12 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03246971


Locations
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United States, California
Lotus Clinical Research
Pasadena, California, United States, 91105
Sponsors and Collaborators
iX Biopharma Ltd.

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Responsible Party: iX Biopharma Ltd.
ClinicalTrials.gov Identifier: NCT03246971     History of Changes
Other Study ID Numbers: KET010
First Posted: August 11, 2017    Key Record Dates
Last Update Posted: July 23, 2018
Last Verified: July 2018

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

Additional relevant MeSH terms:
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Acute Pain
Pain
Neurologic Manifestations
Signs and Symptoms