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Study of OLP-1002 Injections for Reducing Moderate to Severe Pain Due to Osteoarthritis in Hip and/or Knee Joint

NCT05216341 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2024-05-10

No results posted yet for this study

Summary

The study is designed to evaluate the efficacy, safety and tolerability of OLP-1002 Subcutaneous (SC) injections for reducing moderate to severe pain due to osteoarthritis in a hip and/or knee joint.

Conditions

Interventions

DRUG

OLP-1002

Stage 1: A total of 5 participants will be enrolled in each arm in Stage 1. Each participant will receive one single dose of OLP-1002 by subcutaneous injection. Stage 2: Up to 90 participants will be randomised on Day 1 to one of 3 treatment arms, in the ratio of 1:1:1 to receive one single dose of OLP-1002 (1 µg or 2 µg) or placebo. Each participant will receive one single dose of OLP-1002 or placebo by subcutaneous injection.

Sponsors & Collaborators

  • Novotech (Australia) Pty Limited

    collaborator INDUSTRY

  • OliPass Corporation

    lead INDUSTRY

Principal Investigators

  • Andrew Ostor · Emeritus Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-11
Primary Completion
2023-09-07
Completion
2023-09-07

Countries

  • Australia

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 NCT05216341 on ClinicalTrials.gov