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TreatMent Of Knee osTeoarthritis wIth chONdroitin Sulfate - the OA MOTION Study

NCT05632783 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2023-10-05

No results posted yet for this study

Summary

The goal of this phase III study is to evaluate the efficacy, safety, and tolerability of chondroitin sulfate 800 mg oral tablets versus placebo in the treatment of subjects with pain due to knee OA (osteoarthritis). The further aims of the study are to evaluate the durability of the treatment effect (up to week 36) and to gain further long-term safety and efficacy data (up to 48 weeks).

The primary outcome of interest will be the effect of chondroitin sulfate on pain in the index knee at week 24 compared to placebo.

The effect of chondroitin sulfate in the index knee functionality and the patient global impression of changes at 24 weeks compared to placebo are included as key-secondary endpoints. An additional key secondary endpoint will assess the durability of the effect on pain compared to placebo at week 36. Several additional secondary endpoints are included to further support the beneficial effect of the treatment and the improvements in patient's quality of life (i.e., Western Ontario and McMaster Universities Arthritis Index -WOMAC- subscales and total scores at each study visits, changes in patient's quality of life, use of rescue medication etc.) other than the safety of the product.

Conditions

Interventions

DRUG

Chondroitin Sulfate Sodium

Chondroitin sulfate 800 mg tablets

OTHER

Placebo

Placebo tablets

Sponsors & Collaborators

  • IBSA Institut Biochimique SA

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-31
Primary Completion
2025-12-31
Completion
2026-07-31
FDA Drug
Yes

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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 NCT05632783 on ClinicalTrials.gov