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Treatment of Topical Ketorolac Gel in Acute Gouty Flare

NCT06273813 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-02-23

No results posted yet for this study

Summary

This study will be a phase 1, open-label, bioavailability, safety and PK study of topically applied transcutaneous ketorolac tromethamine gel 12.5% (/w) (NOV-1776) versus intravenous administration of approved ketorolac tromethamine injection, USP (15mg/mL) comparator in healthy volunteers, including an evaluation of safety, tolerability, and efficacy in gout participants with flare-up.

Conditions

  • Acute Gouty Arthritis
  • Acute Pain
  • Gout Flare

Interventions

DRUG

Ketorolac Tromethamine 15 MG/ML

Single intravenous administration of Ketorolac Tromethamine injection in Cohort 1 on day 1

DRUG

Ketorolac Tromethamine

Three doses of topical ketorolac tromethamine over the course of 1 day, 6 hours apart for each of 3 subsequent treatment periods in cohort 1 Three doses of Ketorolac Tromethamine, 6 hours apart, over the course of 5 days in cohorts 2 and 3

Sponsors & Collaborators

  • Novilla Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Novotech CRO · Novotech

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-29
Primary Completion
2024-12-31
Completion
2024-12-31
FDA Drug
Yes

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06273813 on ClinicalTrials.gov