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Efficacy and Safety of ATB-346 Versus Placebo in Osteoarthritis Patients

NCT03978208 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 381

Last updated 2022-07-21

No results posted yet for this study

Summary

The primary objective of this study is to evaluate the efficacy of a 14-day dosing regimen of ATB-346 at doses of 150 mg, 200 mg and 250 mg compared to placebo in reducing osteoarthritis knee pain as measured by changes in the post-treatment WOMAC subscale pain score relative to each patient's pretreatment baseline WOMAC assessment.Safety will be assessed via measurements of vital signs and clinical laboratory tests at baseline and at various time points during the study, patient monitoring, and by the documentation of adverse events.

Conditions

Interventions

DRUG

ATB-346 low dose

Double blind comparison of orally administered ATB-346 versus placebo in osteoarthritis patients

OTHER

Placebo

Double blind comparison of orally administered ATB-346 versus placebo in osteoarthritis patients

DRUG

ATB-346 mid-dose

Double blind comparison of orally administered ATB-346 versus placebo in osteoarthritis patients

DRUG

ATB-346 standard dose

Double blind comparison of orally administered ATB-346 versus placebo in osteoarthritis patients

Sponsors & Collaborators

  • Veristat, Inc.

    collaborator OTHER

  • Antibe Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Deepen Patel, MD · Veristat

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-29
Primary Completion
2019-12-29
Completion
2019-12-29

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

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 NCT03978208 on ClinicalTrials.gov