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Clinical Trial to Assess Efficacy, Tolerability of Rising Doses of Clodronate in Painful Knee Osteoarthritis Patients

NCT06263517 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 296

Last updated 2024-02-16

No results posted yet for this study

Summary

The goal of this clinical trial is to to clarify which is the best dose of administration, to select a dose and to confirm the therapeutic efficacy of clodronate in patients with painful knee osteoarthritis (OA). The clinical trial will be divided in two parts.

The main questions it aims to answer are:

* in Phase II, to assess the safety and tolerability of different escalating doses of intra articular (IA) clodronate
* in Phase II, to set a defined therapeutic dose (DTD) to be used in Phase III
* in Phase III, to assess the safety and tolerability of different escalating doses of IA clodronate to confirm and extensively evaluate the therapeutic efficacy and safety of the clodronate DTD in patients with knee OA

Conditions

  • Osteoarthritis of Knee

Interventions

DRUG

Clodronate

For Arm 1, patients will be treated with intra articular clodronate 2 mg/2 ml from Baseline to Week 3

DRUG

Clodronate

For Arm 2, patients will be treated with intra articular clodronate 5 mg/2 ml from Baseline to Week 3

DRUG

Clodronate

For Arm 3, patients will be treated with intra articular clodronate 10 mg/2 ml from Baseline to Week 3

DRUG

Placebo

For Arm 4, patients will be treated with Placebo 2 ml from Baseline to Week 3

Sponsors & Collaborators

  • Pharmaceutical Development and Services

    collaborator UNKNOWN

  • SPA Società Prodotti Antibiotici S.p.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-10-12
Primary Completion
2025-07-31
Completion
2025-10-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

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 NCT06263517 on ClinicalTrials.gov