Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by L.A.L Clinica Pesquisa e Desenvolvimento Ltda..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier:
NCT01293305
First received: February 8, 2011
Last updated: February 9, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention Phase
Osteoarthritis
Drug: Chondroitin sulfate + Glucosamine sulfate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:

Primary Outcome Measures:
  • Promotion of pain relief in patients with osteoarthritis. [ Time Frame: 4 months. ] [ Designated as safety issue: No ]
    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:
  • Functional capacity, overall assessment of clinical improvement, assessment of adverse events [ Time Frame: 4 months. ] [ Designated as safety issue: Yes ]

    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).


Estimated Enrollment: 320
Study Start Date: November 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Chondroitin Sulfate + Glucosamine sulfate
Pharmaceutical form capsule.
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.
Experimental: Chondroitin Sulfate + Glucosamine Sulfate
Oral powder.
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.
Active Comparator: Condroflex®
Pharmaceutical form capsule.
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.
Active Comparator: CONDROFLEX®
Oral powder
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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01293305

Contacts
Contact: Rosa Marcolino Sergio, Doctor +551938293822 sergiomarcolino@uol.com.br

Sponsors and Collaborators
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
  More Information

No publications provided

Responsible Party: Dr. Sergio Marcolino Rosa, LAL Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier: NCT01293305     History of Changes
Other Study ID Numbers: CGSGEO1010
Study First Received: February 8, 2011
Last Updated: February 9, 2011
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:
osteoarthritis

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 27, 2014