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OsteoarthritisPhase 3NCT01293305

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

A Phase 3 study testing Chondroitin sulfate + Glucosamine sulfate in people with Osteoarthritis, run by Azidus Brasil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Osteoarthritis
What is being tested?
Chondroitin sulfate + Glucosamine sulfate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
320 participants
Where
No sites listed yet
Study dates
Nov 2011to Dec 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

No sites are listed yet.

Rosa Marcolino Sergio, Doctor contact

+551938293822

sergiomarcolino@uol.com.br

About this study

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.

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.

Conditions
Osteoarthritis
Being tested
Chondroitin sulfate + Glucosamine sulfate
Keywords
osteoarthritis
Medical subject headings
Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chondroitin sulfate + Glucosamine sulfateDrug

    1 capsule three times daily, preferably in the same period

  • Chondroitin sulfate + Glucosamine sulfateDrug

    1 sachet per day of the drug dissolved in a beaker with 200 mL water.

Study groups in NCT01293305
Study groupRoleWhat they receive
Chondroitin Sulfate + Glucosamine sulfateExperimentalPharmaceutical form capsule.
Receives: Drug: Chondroitin sulfate + Glucosamine sulfate
Chondroitin Sulfate + Glucosamine SulfateExperimentalOral powder.
Receives: Drug: Chondroitin sulfate + Glucosamine sulfate
Condroflex®Active comparatorPharmaceutical form capsule.
Receives: Drug: Chondroitin sulfate + Glucosamine sulfate
CONDROFLEX®Active comparatorOral powder
Receives: Drug: Chondroitin sulfate + Glucosamine sulfate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Promotion of pain relief in patients with osteoarthritis.

    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.

    Measured: 4 months.

Secondary outcomes (1)
  1. Functional capacity, overall assessment of clinical improvement, assessment of adverse events

    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).

    Measured: 4 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2011 (estimated)
  2. Study startNov 2011
  3. Primary completionAug 2012 (estimated)
  4. Study completionDec 2012 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
320 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01293305
Sponsor's protocol ID
CGSGEO1010
Status last verified
Jan 2011
First submitted
8 Feb 2011
Last updated
10 Feb 2011
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Chondroitin sulfate + Glucosamine sulfate in people with Osteoarthritis, run by Azidus Brasil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Rosa Marcolino Sergio, Doctor (+551938293822, sergiomarcolino@uol.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Promotion of pain relief in patients with osteoarthritis. (time frame: 4 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2011.

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