Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00860873
Other study ID # CGSEMS1108
Secondary ID
Status Completed
Phase Phase 3
First received November 26, 2008
Last updated February 22, 2013
Start date October 2009
Est. completion date November 2010

Study information

Verified date February 2013
Source L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Contact n/a
Is FDA regulated No
Health authority Brazil: National Health Surveillance Agency
Study type Interventional

Clinical Trial Summary

This study objective is to check the non-inferiority of the 2 formulations produced by EMS when compared with the same substances and pharmaceuticals forms of the product Condroflex (Zodiac), by promoting the relief of osteoarthrosis symptoms such as pain, stiffness and functional capacity that will be periodically measured by using the "Visual Analog Scale" of pain (VAS) and the questionnaire of Lequesne.


Recruitment information / eligibility

Status Completed
Enrollment 280
Est. completion date November 2010
Est. primary completion date November 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 30 Years to 80 Years
Eligibility Inclusion Criteria:

- Patients who agree with all aspects of the study and sign the Informed Consent;

- Patients of both sexes;

- Age above 30 years;

- Clinical and radiological diagnosis of osteoarthritis;

- Osteoarthritis in grades 1-2;

- Patients who are conducting medical treatment and that, for trial of Investigator, is eligible for the study.

Exclusion Criteria:

- Patients with a history of trauma clinically significant;

- Patients who underwent surgery on joints affected;

- Coexistence of diseases that might impede the successful conclusion of the trial (rheumatism and others);

- Pregnant patients and / or breastfeeding;

- Patients with phenylketonuria;

- Patients with clinical diagnosis of severe renal failure;

- Patients with clinical diagnosis of severe liver disease;

- Patients with clinical diagnosis of clotting disorders;

- Patients who are being treated with anti-aggregating and / or anticoagulants;

- Patients with sensitive components of the formula;

- Patients with emotional disorders that interfere with the capture of data;

- Patients who do not agree with the purposes of the study and did not sign the Informed Consent.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
EMS Chondroitin Sulfate + Glucosamine Sulfate (Oral powder)
Chondroitin Sulfate 1200mg Glucosamine Sulfate 1500mg
EMS Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (hard capsules)
Chondroitin Sulfate 1200mg Glucosamine Sulfate 1500mg
Zodiac: Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (Oral powder)
Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg
Zodiac Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (hard capsules)
Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg

Locations

Country Name City State
Brazil Lal Clinica Pesquisa E Desenvolvimento Ltda Valinhos Sao Paulo

Sponsors (1)

Lead Sponsor Collaborator
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Decrease in pain. V0 (Screening); V1 (Inclusion); V2 (2 weeks); V3 (4 weeks); V4 (8 weeks); V5 (12 weeks); V6 (24 weeks). No
See also
  Status Clinical Trial Phase
Completed NCT02445898 - Effect of Methylprednisolone on Orthostatic Intolerance and Heart Rate Variability in Hip-arthroplasty Patients Phase 2/Phase 3
Completed NCT02542592 - Effect of Methylprednisolone on Immune Signaling in Hip-arthroplasty Patients Phase 2/Phase 3
Completed NCT02910830 - Osteoarthritis Relationships and Tobacco " Ancillary Study Khoala " N/A
Completed NCT01443975 - Clinical Evaluation on the Use of the X-pander Device N/A
Completed NCT01603017 - Nuclear Magnetic Resonance Therapy in Knee Osteoarthrosis N/A
Completed NCT02222740 - A Safety, Tolerability and Pharmacokinetic Dose Escalation Study of HC-ER in Patients With Osteoarthritis Pain Phase 2
Recruiting NCT02923310 - Evaluation of Two Types of PRP in Knee Osteoarthritis Phase 1/Phase 2
Active, not recruiting NCT02518269 - A 3-Arm Study on G7 Acetabular Cup With Echo BiMetric Stem in Total Hip Arthroplasty N/A
Completed NCT03093038 - Early Stability of the Delta-TT Cup With Polyethylene Insert Versus a Ceramic Insert. A RSA Study. N/A
Completed NCT02967874 - Autologous Adipose-Derived Stromal Vascular Fraction Cells for Osteoarthritis Treatment Phase 1/Phase 2
Withdrawn NCT02341079 - Intraoperative Liposomal Bupivacaine Injection in Primary Total Knee Arthroplasty Phase 2/Phase 3
Completed NCT00291499 - Efficacy Study of Condrosulf in the Treatment of Symptomatic OA of the Hand Phase 3
Recruiting NCT05882227 - Nursing Intervention for the Reduction of Anxiety During the Process of Primary Total Hip Arthroplasty Within the Optimized Recovery Program. N/A
Completed NCT05697952 - E1K Intra Articular(IA) Treatment for Knee Osteoarthritis Phase 2
Completed NCT01940692 - Topical and Intravenous Administration of TXA Are Equally Effective in DAA THA Phase 2
Completed NCT02071745 - Navigated Total Knee Arthroplasty, the Correlation to CT Scans and Clinical Results N/A
Completed NCT02332616 - Effect of Methylprednisolone on Complement Activation in Patients Undergoing Total Knee-arthroplasty Phase 3
Completed NCT02319343 - Effect of Methylprednisolone on Quadriceps Muscle Function in Patients Undergoing Total Knee-arthroplasty Phase 3
Completed NCT02332629 - Effect of Methylprednisolone on Endothelial Function in Patients Undergoing Total Knee-arthroplasty Phase 3
Completed NCT02332603 - Effect of Methylprednisolone on Glucose Homeostasis in Patients Undergoing Total Hip- and Knee-arthroplasty Phase 3