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NCT03246971

Study of Wafermine™ for Post-bunionectomy or Abdominoplasty Pain

Completed Phase 2 Last updated 23 July 2018
What this trial tests

Phase 2 trial testing Wafermine™ 50 mg in Acute Pain in 125 participants. Completed in 17 July 2018.

Timeline
24 August 2017
Primary endpoint
12 July 2018
17 July 2018

Quick facts

Lead sponsoriX Biopharma Ltd.
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment125
Start date24 August 2017
Primary completion12 July 2018
Estimated completion17 July 2018
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

iX Biopharma Ltd. — full company profile →

Who can join

Adults 18 to 75, any sex, with Acute Pain or Bunion. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Abdominoplasty as an acute postoperative pain model: insights from 8 years of clinical trials.
    Singla N, Singla N, Rogier T. · · 2023 · cited 6× · PMID 35947083 · DOI 10.1097/j.pain.0000000000002736

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03246971.

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