Study With Chondroitin Sulfate and Glucosamine Sulfate (in Dosage Capsule and Sachet) in Treating Osteoarthritis

Phase 3

• Conditions: Osteoarthritis
• Interventions: Drug: Chondroitin sulfate + Glucosamine sulfate

• Registration Number: NCT01293305
• Lead Sponsor: Azidus Brasil

Brief Summary

The use of chondroitin sulfate and glucosamine sulfate has been recognized since the 70 decade in the treatment of osteoarthritis. Numerous clinical trials have demonstrated the therapeutic properties of this association in control of osteoarthritis, especially in reducing pain and improving movement. The combination of chondroitin sulfate with glucosamine sulfate offers a significantly higher tolerance than most drug treatments and, moreover, has long lasting effects even after stopping treatment.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-01
• Study First Submitted: 2011-02-08
• Study First Submitted QC: 2011-02-09
• Last Update Submitted: 2011-02-09
• Study First Posted: 2011-02-10
• Last Update Posted: 2011-02-10
• Study Start: 2011-11
• Primary Completion: 2012-08
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chondroitin Sulfate + Glucosamine sulfate	Chondroitin sulfate + Glucosamine sulfate	Pharmaceutical form capsule.
Chondroitin Sulfate + Glucosamine Sulfate	Chondroitin sulfate + Glucosamine sulfate	Oral powder.
Condroflex®	Chondroitin sulfate + Glucosamine sulfate	Pharmaceutical form capsule.
CONDROFLEX®	Chondroitin sulfate + Glucosamine sulfate	Oral powder

Primary Outcome Measures

Name	Time	Method
Promotion of pain relief in patients with osteoarthritis.	4 months.	Assessment of noninferiority clinical association Chondroitin + glucosamine in dosage forms and oral powder hard gelatin capsule, produced by Geolab Pharmaceutical Ltd., with the comparator drugs in the same dosage forms produced by the Laboratory Zodiac (Condroflex ®) through the promotion of pain relief in patients with osteoarthritis between grades 1 and 3, according to the classification of Kellgreen \& Lawrence (1957), measured by visual analogue scale (VAS). There will be five visits: V0, V1, V2, V3 and V4.

Secondary Outcome Measures

Name	Time	Method
Functional capacity, overall assessment of clinical improvement, assessment of adverse events	4 months.	Are the secondary objectives: * Functional capacity before and after treatment, using the Lequesne questionnaire, comparing the groups (T and Co).; * Overall evaluation of clinical improvement made by the principal investigator.; * Incidence of use of painkillers and anti-inflammatory drugs orally for the treatment through the patient's report, comparing the groups (T and Co).; * Evaluation of the incidence, type and intensity of adverse events during the study, comparing the groups (T and Co).