A Study Of The Effectiveness Of Wafermine Alone And In Combination With Opioids In Subjects Undergoing Bunionectomy
NCT ID: NCT02541396
Last Updated: 2016-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
72 participants
INTERVENTIONAL
2015-10-31
2015-12-31
Brief Summary
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Detailed Description
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Study subjects will receive multiple doses of study medication over a 14 hour period and will be asked to complete pain and relief assessments as well as tolerability questionnaires over a 24 hour period.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Group A
Placebo wafers given every 2 hours Placebo capsule given every 4 hours Placebo wafers "top-up" dose given at hour 1
Placebo
Placebo capsule or placebo wafer
Group B
Placebo wafers given every 2 hours Oxycodone given every 4 hours Placebo wafers "top-up" dose given at hour 1
Oxycodone
5 mg oxycodone capsule
Group C
Wafermine™ 35 mg wafer + placebo wafer given every 2 hours Placebo capsule given every 4 hours Wafermine™ 35 mg wafer + placebo wafer "top-up" dose at hour 1
Wafermine
35 or 70 mg ketamine in a sublingual wafer
Group D
Wafermine™ 35 mg wafer + placebo wafer given every 2 hours Oxycodone 5 mg capsule every 4 hours Wafermine™ 35 mg "wafer + placebo wafer top-up" dose at hour 1
Wafermine
35 or 70 mg ketamine in a sublingual wafer
Oxycodone
5 mg oxycodone capsule
Group E
Wafermine™ 35 mg + placebo wafer given every 4 hours Placebo wafers given every 2 hours Placebo capsule given every 4 hours Wafermine™ 35 mg wafer + placebo wafer "top-up" dose at hour 1
Wafermine
35 or 70 mg ketamine in a sublingual wafer
Group F
Wafermine™ 35 mg + placebo wafer given every 4 hours Placebo wafers given every 2 hours Oxycodone 5 mg given every 4 hours Wafermine™ 35 mg wafer + placebo wafer "top-up" dose at hour 1
Wafermine
35 or 70 mg ketamine in a sublingual wafer
Oxycodone
5 mg oxycodone capsule
Group G
Wafermine™ 70 mg given every 4 hours Placebo wafer given every 2 hours Placebo capsule given every 4 hours 2 Placebo wafers "top-up" dose at hour 1
Wafermine
35 or 70 mg ketamine in a sublingual wafer
Interventions
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Wafermine
35 or 70 mg ketamine in a sublingual wafer
Oxycodone
5 mg oxycodone capsule
Placebo
Placebo capsule or placebo wafer
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Healthy, ambulatory subjects able to understand and willing to comply with study procedures, study restrictions and requirements.
* Body mass index (BMI) ≥19 to ≤33 kg/m2.
* Females: Not pregnant, not lactating, and not planning to become pregnant during the study.
* Females: Be abstinent, surgically sterile, at least two years post-menopausal; or medically acceptable contraception.
* Able to read and understand English.
* Able to swallow oral capsules whole.
Exclusion Criteria
* Clinically significant medical condition.
* History of illicit drug use or alcohol abuse and not in full remission.
* Positive test for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) at the screening visit.
* Clinically significant 12 lead ECG abnormalities at screening.
* Smokers who are unwilling to abstain during the inpatient stay.
18 Years
ALL
No
Sponsors
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Jean Brown Research
OTHER
iX Biopharma Ltd.
OTHER
Responsible Party
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Locations
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Jean Brown Research
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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KET009
Identifier Type: -
Identifier Source: org_study_id
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