CompletedPhase 2Other

Study of Wafermine™ for Post-bunionectomy or Abdominoplasty Pain

Sponsored by iX Biopharma Ltd.

NCT ID
NCT03246971
Target Enrollment
125 participants
Start Date
2017-08-24
Est. Completion
2018-07-17

About This Study

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.

Conditions Studied

Acute PainBunionAbdominoplasty

Interventions

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

Eligibility

Age:18 Years - 75 Years
Healthy Volunteers:Yes
View full 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

Study Locations (1)

Lotus Clinical Research
Pasadena, California, United States

This trial is not recruiting

This study has completed enrollment. Check back for results or find similar trials.

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Data Source
ClinicalTrials.gov

Last updated from source