Efficacy an tolerability of a combinatzion of glucosamine sulphate and the tw omega-3 unsaturated fatty acids EPA and DHA in comparison to glucosamine sulphate in patients with ostearthritis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-003669-18-DE

Enrollment

182

Registered

2006-03-01

Start date

2006-11-15

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Interventions

Product Name: GlucOmega Pharmaceutical Form: Capsule* CAS Number: 8000051481 Other descriptive name: FISH OIL Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 444- I

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age: 40 - 75 years (contraception of women of childbearing age) - Currently untreated osteoarthritic complaints with moderate to severe pain (WOMAC pain score = 300 - 400 mm) - Functional disability of the hip or knee joint Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Severe organ and systemic diseases, particularly those which reduce liver and kidney function or gastrointestinal diseases - Treatment with steroidal or non-steroidal antirheumatics - Use of dietary supplements which contain omega-3 fatty acids (e. g. fish oil), gammalinolenic acid (e. g. evening primrose oil, borage seed oil), glucosamine (glucosamine sulphate or glucosamine hydrochloride) and/or chondroitin

Design outcomes

Primary

Measure	Time frame
Main Objective: Responders with regard to reduction of 20% in the WOMAC pain score and of the observation period as opposed to the baseline value;Secondary Objective: WOMAC pain score and WOMAC subscores "stiffness" and "function";Primary end point(s): Comparison of the percentage of responders with regard to the reduction in the WOMAC pain score at the end of the clinical trial by 20% as opposed to the baseline values between the two groups	—

Measure

Time frame

Main Objective: Responders with regard to reduction of 20% in the WOMAC pain score and of the observation period as opposed to the baseline value;Secondary Objective: WOMAC pain score and WOMAC subscores "stiffness" and "function";Primary end point(s): Comparison of the percentage of responders with regard to the reduction in the WOMAC pain score at the end of the clinical trial by 20% as opposed to the baseline values between the two groups

—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026