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COMPLETED Phase 2

Study of Wafermine™ for Post-bunionectomy or Abdominoplasty Pain

NCT03246971 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

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

Study Locations (1)

California

  • Lotus Clinical Research — Pasadena

Trial Details

FieldValue
Enrollment Target 125 participants
Start Date 2017-08-24
Est. Completion 2018-07-17
Phase Phase 2

Sponsor

iX Biopharma

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03246971

The ClinicalTrials.gov registry entry for NCT03246971 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 125 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is iX Biopharma, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Acute Pain appearing as the primary indexed condition, and to 4 interventions — of which Placebos is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03246971 reports 1 study location spanning 1 distinct geographic area — top geographies include California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03246971 about?

NCT03246971 is a clinical study titled "Study of Wafermine™ for Post-bunionectomy or Abdominoplasty Pain". 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 abdominopl...

What is the current status of trial NCT03246971?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 125 participants. The study started on 2017-08-24. Estimated completion is 2018-07-17.

What conditions does trial NCT03246971 study?

This clinical trial studies the following conditions: Acute Pain, Bunion, Abdominoplasty. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03246971?

The interventions under investigation include: Placebos (DRUG), Wafermine™ 50 mg (DRUG), Wafermine™ 75 mg (DRUG), Wafermine™ 25 mg (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03246971?

This trial is sponsored by iX Biopharma, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03246971 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial