Study of Wafermine™ for Post-bunionectomy or Abdominoplas... | NCT03246971

Studies
Study of Wafermine™ for Post-bunionectomy or Abdominoplasty Pain

NCT03246971

Sponsor

iX Biopharma Ltd.

Status

Completed

Last Update Posted

Jul 23, 2018Actual

Enrollment

125Actual

Phase

Phase 2

Conditions

Acute Pain
Bunion
Abdominoplasty

Interventions

Wafermine™ 50 mg
Wafermine™ 75 mg
Placebos
Wafermine™ 25 mg

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 24, 2017Actual

Primary Completion Date

Jul 12, 2018Actual

Completion Date

Jul 17, 2018Actual

First Submitted Date

Aug 8, 2017

First Submission Date that Met QC Criteria

Aug 10, 2017

First Posted Date

Aug 11, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 19, 2018

Last Update Posted Date

Jul 23, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

125Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Wafermine™	Experimental		Drug: Wafermine™ 50 mg Drug: Wafermine™ 75 mg Drug: Wafermine™ 25 mg
Placebo	Placebo Comparator		Drug: Placebos

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Wafermine™ 50 mg	Drug	Administered as needed for 12 hours	Wafermine™

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Summed Pain Intensity Differences (SPID) using a Numerical Rating Scale		12 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lotus Clinical Research		Pasadena	California	91105	United States

Condition Browse Module

MeSH Terms

ID	Term
D059787	Acute Pain
D000071378	Bunion

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided