Study of Wafermine™ for Post-bunionectomy or Abdominoplasty Pain

NCT ID: NCT03246971

Last Updated: 2018-07-23

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-24

Study Completion Date

2018-07-17

Brief Summary

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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

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Conditions

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Acute Pain Bunion Abdominoplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Wafermine™

Group Type EXPERIMENTAL

Wafermine™ 50 mg

Intervention Type DRUG

Administered as needed for 12 hours

Wafermine™ 75 mg

Intervention Type DRUG

Administered as needed for 12 hours

Wafermine™ 25 mg

Intervention Type DRUG

Administered as needed for 12 hours

Placebo

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

Administered as needed for 12 hours

Interventions

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Wafermine™ 50 mg

Administered as needed for 12 hours

Intervention Type DRUG

Wafermine™ 75 mg

Administered as needed for 12 hours

Intervention Type DRUG

Placebos

Administered as needed for 12 hours

Intervention Type DRUG

Wafermine™ 25 mg

Administered as needed for 12 hours

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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iX Biopharma Ltd.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Lotus Clinical Research

Pasadena, California, United States

Site Status

Countries

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United States

Other Identifiers

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KET010

Identifier Type: -

Identifier Source: org_study_id

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