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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified January 2011 by Azidus Brasil.
Recruitment status was: Not yet recruiting

Sponsor:

Information provided by:

Azidus Brasil

ClinicalTrials.gov Identifier:

NCT01293305

First received: February 8, 2011

Last updated: February 9, 2011

Last verified: January 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

February 8, 2011

Last Updated Date

February 9, 2011

Start Date ^ICMJE

November 2011

Estimated Primary Completion Date

August 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Promotion of pain relief in patients with osteoarthritis. [ Time Frame: 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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Functional capacity, overall assessment of clinical improvement, assessment of adverse events [ Time Frame: 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).

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Randomized Evaluation Of Not Less Medical Association Chondroitin Sulfate Plus Glucosamine Sulfate (In Powder Dosage Forms And Oral Capsule), Manufactured By The Geolab Pharmaceutical Industry Ltd, Compared To The Drug Condroflex® (Powder And Oral Capsule), Manufactured In The Laboratory Zodiac, The Treatment Of Osteoarthritis.

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Osteoarthritis

Intervention ^ICMJE

Drug: Chondroitin sulfate + Glucosamine sulfate
1 capsule three times daily, preferably in the same period
Drug: Chondroitin sulfate + Glucosamine sulfate
1 sachet per day of the drug dissolved in a beaker with 200 mL water.

Study Arms

Experimental: Chondroitin Sulfate + Glucosamine sulfate
Pharmaceutical form capsule.
Interventions:
- Drug: Chondroitin sulfate + Glucosamine sulfate
- Drug: Chondroitin sulfate + Glucosamine sulfate
Experimental: Chondroitin Sulfate + Glucosamine Sulfate
Oral powder.
Interventions:
- Drug: Chondroitin sulfate + Glucosamine sulfate
- Drug: Chondroitin sulfate + Glucosamine sulfate
Active Comparator: Condroflex®
Pharmaceutical form capsule.
Interventions:
- Drug: Chondroitin sulfate + Glucosamine sulfate
- Drug: Chondroitin sulfate + Glucosamine sulfate
Active Comparator: CONDROFLEX®
Oral powder
Interventions:
- Drug: Chondroitin sulfate + Glucosamine sulfate
- Drug: Chondroitin sulfate + Glucosamine sulfate

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Unknown status

Estimated Enrollment ^ICMJE

320

Estimated Completion Date

December 2012

Estimated Primary Completion Date

August 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Constitute the criteria for inclusion in the study:

Patients who agree with all aspects of the study and sign the Informed Consent
Patients older than 40 years, regardless of sex
Patients with clinical and radiological osteoarthritis in at least one knee, grade 1, 2 or 3 (based on clinical and radiological criteria of Kellgren & Lawrence). In the case of involvement of both knees the knee will be evaluated with greater impairment due to illness
Patients with symptoms of pain when moving the knee examined in the study on most days of the last month, also in view of randomization of study drugs (V0)
Symptoms of osteoarthritis, expressed continuously or intermittently over the last 6 months preceding the study

Constitute the criteria for exclusion from the study:

History of clinically significant trauma to less than 3 months and to keep the clinical signs of trauma
Patients who have performed surgery (including arthroscopy) in the affected joints less than 3 months and, at the discretion of the investigators, might interfere with study evaluations
clinical history compatible with arthropathy that may confuse or interfere with pain assessment and effectiveness, including an inflammatory arthropathy (rheumatoid arthritis, lupus erythematosus, espondialoartropatia, psoriatic arthritis, polymyalgia rheumatica) gout, episodes of acute monoarthritis consistent with pseudogout, Paget's disease with involvement of the joint study, a history of septic arthritis, and Wilson disease, hemochromatosis, alkaptonuria, primary osteochondromatosis, history of avascular necrosis or intra-articular fracture of the joint study
Patients with isolated patellofemoral arthrosis
Patients who are pregnant or of childbearing potential without contraception
Patients who are breastfeeding
Patients with a history of PKU
Patients with clinical diagnosis of severe renal insufficiency
Patients with clinical diagnosis of severe liver diseases
Patients with clinical diagnosis of bleeding disorders
Patients who are being treated with oral anticoagulants or systemic
Treatment with corticosteroids:

Use of corticosteroids orally or intramuscularly, fast action, for up to two weeks before V-1 or 14 days before the scheduled visits Use of oral corticosteroids or intramuscular depot for up to 4 weeks before V-1 or 14 days before the scheduled visits the administration of intra-articular corticosteroids in the study joint in the 3 months prior to randomization visit (V0) or during the study the administration of intra-articular corticosteroid into any other joint for up to 4 weeks prior to randomization visit (V0) or during the study

Patients who have received intra-articular injection of hyaluronic acid or counterparts in the joint study in the past 12 months and during the study period
Topical use of analgesics and irregular in the joint under study (eg, capsaicin) due to the possibility of causing a worsening of pain
Use oral and / or systemic analgesics high power (opioids, tramadol) often or last week before the inclusion visit (V0)
Implementation of any other medical treatment for osteoarthritis in the month prior to entry in the trial or a change of medical treatment already available, such as aerobics or physical therapy
Clinical diagnosis established uncontrolled diabetes mellitus, with fasting glucose greater than 126 mg / dL
Patients with a history of daily consumption of alcohol or, at the discretion of the investigator, be considered abusive
Patients with hypersensitivity or a history of clinical or laboratory adverse event to acetaminophen, chondroitin sulfate and glucosamine sulfate
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

Sex/Gender

Sexes Eligible for Study:

All

Ages

40 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Not Provided

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01293305

Other Study ID Numbers ^ICMJE

CGSGEO1010

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Dr. Sergio Marcolino Rosa, LAL Clinica Pesquisa e Desenvolvimento Ltda.

Study Sponsor ^ICMJE

Azidus Brasil

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

PRS Account

Azidus Brasil

Verification Date

January 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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