Mechanisms of Action of Glucosamine Hydrochloride / Chondroitin Sulphate (Cosamin￤) and Clinical Response in Osteoarthritis ⿿ a Pilot Study

Phase 1

Completed

• Conditions: Osteoarthritis; Musculoskeletal - Osteoarthritis

• Registration Number: ACTRN12605000529640
• Lead Sponsor: ature Vet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-26
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Subjects with a diagnosis of OA of the hip or knee, with or without other joint involvement, as defined by:i) hip or knee pain while standing, walking and/or in motion of at least 3 months duration, andii) evidence of one or more of the following features in an X-ray picture: osteophytes, osteosclerosis, cysts or joint space narrowing, andiii) a total WOMAC score of 10 or more at study commencementSubjects who have given their informed written consent.Subjects willing to discontinue their current OA treatment for the study duration, commencing at least 4 weeks prior to study commencement. This includes treatment with intra-articular injections, corticosteroids, NSAIDs, non-prescription therapies, chondroprotective agents, occlusive dressings, physiotherapy, or orthopaedic technical measures.Subjects of childbearing age who agree to continue using contraceptive measures for the duration of the study.Subjects with good venous access.

Exclusion Criteria

Severe false alignment of the axis of the knee or hip.Surgery on the knee or hip within the past 2 months or arthroscopy within the past 2 months.Administration of intra-articular injections (e.g. corticosteroids, chondroprotective agents) or treatment with any long acting osteoarthritic therapy in the previous 2 months.Infectious or inflammatory diseases.Female subjects who are pregnant or lactating.Subjects who are unwilling to comply with the study requirements including discontinuation of current osteoarthritis treatment.Subjects with any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objective.Subjects with contra-indications to the study medication or to paracetamol.Reliance on the use of lipolytic, fibrinolytic, anti-coagulant or anti-inflammatory agents or agents that influence platelet function (including but not restricted to - aspirin, aspirin containing compounds and other NSAIDs).A history of trauma associated with the affected joints.Subjects with significant gastrointestinal or renal disease.Subjects with any bleeding disorder.Subjects with a history of alcohol or substance abuse.

Study & Design

• Study Type: Interventional
• Study Design: Not specified