Efficacy and Safety Study of Glucosamine/Chondroitin Sulfate to Patients Treatment With Osteoarthrosis of the Knee

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-06-30

Brief Summary

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The purpose of this study is to assess the efficacy and safety of glucosamine and chondroitin sulfate association in the treatment of patients with osteoarthrosis of the knee.

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Detailed Description

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To assess the efficacy and safety of the association of glucosamine sulphate 500 mg/chondroitin sulphate 400 mg (Eurofarma) in the treatment of osteoarthritis, compared to Cosamin DS® (Nutramax) in same presentation and pharmaceutical form.

Some eligibility criteria:

Osteoarthritis of the knee confirmed by radiological examination; Visual analogue scale (VAS) \> 40 mm; Clinical diagnosis of pain and functional limitation

Conditions

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Osteoarthritis of the Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Cosamin DS®

glucosamine hydrochloride 500 mg and chondroitin sulfate 400 mg (Cosamin DS®, Nutramax Laboratories).

The medication was supplied as capsules, with the daily dose of 3 capsules.

Group Type ACTIVE_COMPARATOR

Cosamin DS® (Nutramax)

Intervention Type DRUG

oral capsule of glucosamine hydrochloride 500 mg + chondroitin sulphate 400 mg thrice daily before meals. Period: 127 days

Glucosamine/ chondroitin sulphate

Glucosamine hydrochloride 500 mg and chondroitin sulphate 400 mg association (Eurofarma) T.I.D. before each meal The medication was supplied as capsules, with the daily dose of 3 capsules.

Group Type EXPERIMENTAL

Glucosamine sulphate and chondroitin sulphate association

Intervention Type DRUG

glucosamine sulphate 500 mg and chondroitin sulphate 400 mg association T.I.D. before each meal

Interventions

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Glucosamine sulphate and chondroitin sulphate association

glucosamine sulphate 500 mg and chondroitin sulphate 400 mg association T.I.D. before each meal

Intervention Type DRUG

Cosamin DS® (Nutramax)

oral capsule of glucosamine hydrochloride 500 mg + chondroitin sulphate 400 mg thrice daily before meals. Period: 127 days

Intervention Type DRUG

Other Intervention Names

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Glucosamine sulphate and Chondroitin sulphate Cosamin DS® glucosamine hydrochloride and chondroitin sulphate

Eligibility Criteria

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Inclusion Criteria

* Subjects have to read and sign the approved the Informed Consent form prior to any participation in the study.
* Male or female Subjects, aged upper to 40 years.
* Osteoarthritis of the knee confirmed by radiological examination.
* Visual analogue scale (VAS) \> 40 mm.
* Kellgren and Lawrence grade 1 to 3.
* Clinical diagnosis of pain and functional limitation.

Exclusion Criteria

* History of significant trauma or surgery in the affected joint.
* Pregnant women, lactating or not using appropriate contraceptive method.
* History or presence of active rheumatic disease that may be responsible for secondary osteoarthritis.
* Severe inflammation of the joint confirmed by physical examination (excluding also erythrocyte sedimentation \<40mm/h and rheumatoid factor \<1:40).
* Body mass index \> 30.
* Hematologic abnormalities, liver, renal or metabolic functions which undermine the serious participation of the patient (at investigator's criteria).
* Systemic administration and/or intra-articular corticosteroids in the last 3 months.
* Have made use of glucosamine and/or chondroitin.
* Lequesne index of \> 12.
* Arthroplasty in the affected joint.
* Use of narcotic analgesics.
* Any condition that, in the opinion of the investigator, renders the patient unable to participate in the study.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No