NCT03246971

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2017

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 11, 2017

Completed
13 days until next milestone

Study Start

First participant enrolled

August 24, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2018

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 17, 2018

Completed
Last Updated

July 23, 2018

Status Verified

July 1, 2018

Enrollment Period

11 months

First QC Date

August 8, 2017

Last Update Submit

July 19, 2018

Conditions

Acute PainBunionAbdominoplasty

Outcome Measures

Primary Outcomes (1)

  • Summed Pain Intensity Differences (SPID) using a Numerical Rating Scale

    12 hours

Study Arms (2)

Wafermine™

EXPERIMENTAL
Drug: Wafermine™ 50 mgDrug: Wafermine™ 75 mgDrug: Wafermine™ 25 mg

Placebo

PLACEBO COMPARATOR
Drug: Placebos

Interventions

Wafermine™ 50 mgDRUG

Administered as needed for 12 hours

Wafermine™
Wafermine™ 75 mgDRUG

Administered as needed for 12 hours

Wafermine™
PlacebosDRUG

Administered as needed for 12 hours

Placebo
Wafermine™ 25 mgDRUG

Administered as needed for 12 hours

Wafermine™

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • For those undergoing bunionectomy, other painful conditions involving the surgical foot.
  • Positive lab values for Hepatitis B or C or HIV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lotus Clinical Research

Pasadena, California, 91105, United States

Location

MeSH Terms

Conditions

Acute PainBunion

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsFoot Deformities, AcquiredFoot DeformitiesMusculoskeletal Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2017

First Posted

August 11, 2017

Study Start

August 24, 2017

Primary Completion

July 12, 2018

Study Completion

July 17, 2018

Last Updated

July 23, 2018

Record last verified: 2018-07

Locations

US(1)