Knee OsteoarthritisPhase 3NCT02010918
Efficacy and Safety of Glucosamine Sulfate and Chondroitin Sulfate Combination in Treatment of Knee Osteoarthritis
A Phase 3 study testing glucosamine sulfate /chondroitin sulfate - capsules, glucosamine sulfate /chondroitin sulfate - sachet and Cosamin DS® in people with Knee Osteoarthritis, run by Ache Laboratorios Farmaceuticos S.A. at 1 site in Brazil.
Trial summary
The purpose of this study is to determine whether 500 mg Glucosamine Sulfate / 400 mg Chondroitin Sulfate Capsules and 1500 mg Glucosamine Sulfate / 1200 mg Chondroitin Sulfate Sachet is effective and safe compared Cosamin DS ® Capsule in Treatment of Knee Osteoarthritis. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- glucosamine sulfate /chondroitin sulfate - capsules, glucosamine sulfate /chondroitin sulfate - sachet and Cosamin DS®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 922 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2009to Nov 2010
- 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
Who may be able to join
- Male or female patient, older than 40 years of age, with knee osteoarthritis, based on clinical and radiological criteria (Kellgren-Lawrence grade 2 - 3), as specified:
- Pain on movement of the affected knee for more than 15 days in the previous month with at least partial relief at rest;
- Presence of osteophytes at least 1 mm in radiological imaging;
- Knee osteoarthritis symptoms for at least six months prior to randomization.
Who cannot join
- Concomitant arthropathy that may confuse or interfere with assessing the efficacy or pain;
- Patellar disease isolated, with primary symptoms of pain in the anterior knee, in the absence of radiological findings already described;
- History of significant injury on collateral ligament, or anterior cruciate, or meniscus of the joint studied, with surgery, or immobilization for at least 3 weeks;
- Arthroscopy of the affected knee in last 6 months;
- Serum creatinine ≥ 1.8 mg/dL;
- Diagnosis of diabetes mellitus;
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- Presence of any serious disease that could compromise the study, at the investigator discretion;
- History of adverse event or allergy to acetaminophen, glucosamine sulfate or chondroitin sulfate;
- Inability to understand and report the study questionnaire and the Visual Analogic Scale;
- Inability to understand and consent to participate in this clinical study, expressed by signing the Informed Consent (IC);
- Woman in pregnancy.
- If female of childbearing potential, has a negative urine pregnancy test at Visit 0 and do not use, or do not agree to use, for the duration of the study, a medically acceptable form of contraception as determined by the investigator;
- Alcohol intake ( > 3 doses/day);
- Oral or intramuscular corticosteroids four weeks prior to study entry;
- Intra-articular injections with corticosteroids, into the studied knee, within the past three months;
- Intra-articular injections in any other joint within the past four weeks;
- NSAID users that don´t respect the washout period. Low-dose aspirin (325 mg or less, once daily) is allowed for cardio-protective benefit;
- Intra-articular injections of hyaluronic acid within the past 12 months;
- Use of topical analgesic in the joint studied or any other oral analgesic (with the exception of acetaminophen and other NSAID) two weeks prior to randomization;
- Implementation of any other medical treatment for osteoarthritis one month prior to study entry;
- Participation in last one year of clinical protocols, unless it can be direct benefit to patient;
- Use of glucosamine and/or chondroitin sulfate three and six months prior the study entry, respectively;
- Initiation of physical therapy two months prior to the study period;
- Use of tetracycline and oral anticoagulants;
- Use of vitamin D in doses in doses above the recommended;
- Patients in alternative therapies;
- Allergy to sulfonamides;
- Presence of psychiatric disorders that could compromise the study.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Serviço de reumatologia do hospital e maternidade celso pierro da PUC-Campinas
Campinas, São Paulo, 13330-260
About this study
Official title: A Phase III, Multicenter, Randomized, Parallel, Open Label and Comparative Study to Evaluate the Efficacy of 500 mg Glucosamine Sulfate (GS) / 400 mg Chondroitin Sulfate (CS)Capsules and 1500 mg GS / 1200 mg CS Sachet Compared With Cosamin DS® Capsule in Treatment of Knee Osteoarthritis..
The purpose of this study is to determine whether 500 mg Glucosamine Sulfate / 400 mg Chondroitin Sulfate Capsules and 1500 mg Glucosamine Sulfate / 1200 mg Chondroitin Sulfate Sachet is effective and safe compared Cosamin DS ® Capsule in Treatment of Knee Osteoarthritis.
Read the detailed description
The Groups receive treatment for 16 weeks. The study is realized in 16 sites in Brazil.
- Conditions
- Knee Osteoarthritis
- Being tested
- glucosamine sulfate /chondroitin sulfate - capsules, glucosamine sulfate /chondroitin sulfate - sachet, Cosamin DS®
- Keywords
- Knee Osteoarthritis;, Glucosamine;, Chondroitin.
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glucosamine sulfate /chondroitin sulfate - capsulesDrug
500 mg glucosamine sulfate + 400 mg chondroitin sulfate - capsules; One capsule, three times daily.
glucosamine sulfate /chondroitin sulfate - sachetDrug
1500 mg glucosamine sulfate / 1200 mg chondroitin sulfate - sachet; One sachet preparation, once daily.
Cosamin DS®Drug
500 mg glucosamine hydrochloride + 400 mg chondroitin sulfate - Capsules; One capsule, three times daily.
| Study group | Role | What they receive |
|---|---|---|
| glucosamine sulfate /chondroitin sulfate capsule | Experimental | 500 mg glucosamine sulfate + 400 mg chondroitin sulfate - capsules; One capsule, three times daily. Receives: Drug: glucosamine sulfate /chondroitin sulfate - capsules |
| glucosamine sulfate /chondroitin sulfate - sachet | Experimental | 1500 mg glucosamine sulfate / 1200 mg chondroitin sulfate - sachet; One sachet preparation, once daily. Receives: Drug: glucosamine sulfate /chondroitin sulfate - sachet |
| Cosamin DS® | Active comparator | 500 mg glucosamine hydrochloride + 400 mg chondroitin sulfate - Capsules; One capsule, three times daily. Receives: Drug: Cosamin DS® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in pain intensity in the affected knee and variation of Lequesne's index and VAS at week 16 .
Measured: BASELINE, week 16
Secondary outcomes (1)
Percentage of Participants with any Decrease in Pain Visual Analogue Scale (VAS)
Measured: baseline, week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2013 (estimated)
- Study startFeb 2009
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- None (open label)
- Enrolment
- 922 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ache Laboratorios Farmaceuticos S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- José R Provenza, MD, Principal investigator, Pontifícia Universidade Católica de Campinas, São Paulo, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02010918
- Sponsor's protocol ID
- ACH-ART-03(01/08)
- Status last verified
- Dec 2013
- First submitted
- 19 Jul 2013
- Last updated
- 13 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicenter, Randomized, Parallel, Open Label and Comparative Study to Evaluate the Efficacy of 500 mg Glucosamine Sulfate (GS) / 400 mg Chondroitin Sulfate (CS)Capsules and 1500 mg GS / 1200 mg CS Sachet Compared With Cosamin DS® Capsule in Treatment of Knee Osteoarthritis..
- ClinicalTrials.gov ID
- NCT02010918
- Acronym / sponsor ID
- ACH-ART-03(01/08)
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee Osteoarthritis;, Glucosamine;, Chondroitin.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 922 participants (actual)
- Lead sponsor
- Ache Laboratorios Farmaceuticos S.A.Industry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 13 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether 500 mg Glucosamine Sulfate / 400 mg Chondroitin Sulfate Capsules and 1500 mg Glucosamine Sulfate / 1200 mg Chondroitin Sulfate Sachet is effective and safe compared Cosamin DS ® Capsule in Treatment of Knee Osteoarthritis.
Detailed description
The Groups receive treatment for 16 weeks. The study is realized in 16 sites in Brazil.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| glucosamine sulfate /chondroitin sulfate capsule | Experimental | Drug: glucosamine sulfate /chondroitin sulfate - capsules500 mg glucosamine sulfate + 400 mg chondroitin sulfate - capsules; One capsule, three times daily. |
| glucosamine sulfate /chondroitin sulfate - sachet | Experimental | Drug: glucosamine sulfate /chondroitin sulfate - sachet1500 mg glucosamine sulfate / 1200 mg chondroitin sulfate - sachet; One sachet preparation, once daily. |
| Cosamin DS® | Active comparator | Drug: Cosamin DS®500 mg glucosamine hydrochloride + 400 mg chondroitin sulfate - Capsules; One capsule, three times daily. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female patient, older than 40 years of age, with knee osteoarthritis, based on clinical and radiological criteria (Kellgren-Lawrence grade 2 - 3), as specified:
- Knee osteoarthritis symptoms for at least six months prior to randomization.
Key exclusion criteria (28 listed)
- Concomitant arthropathy that may confuse or interfere with assessing the efficacy or pain;
- Patellar disease isolated, with primary symptoms of pain in the anterior knee, in the absence of radiological findings already described;
- History of significant injury on collateral ligament, or anterior cruciate, or meniscus of the joint studied, with surgery, or immobilization for at least 3 weeks;
- Arthroscopy of the affected knee in last 6 months;
- Serum creatinine ≥ 1.8 mg/dL;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| glucosamine sulfate /chondroitin sulfate - capsules500 mg glucosamine sulfate + 400 mg chondroitin sulfate - capsules; One capsule, three times daily. | Drug | glucosamine sulfate /chondroitin sulfate capsule |
| glucosamine sulfate /chondroitin sulfate - sachet1500 mg glucosamine sulfate / 1200 mg chondroitin sulfate - sachet; One sachet preparation, once daily. | Drug | glucosamine sulfate /chondroitin sulfate - sachet |
| Cosamin DS®500 mg glucosamine hydrochloride + 400 mg chondroitin sulfate - Capsules; One capsule, three times daily. | Drug | Cosamin DS® |
Primary outcome
Change from baseline in pain intensity in the affected knee and variation of Lequesne's index and VAS at week 16 .
Time frame: BASELINE, week 16
1 secondary outcome
Percentage of Participants with any Decrease in Pain Visual Analogue Scale (VAS)
Time frame: baseline, week 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José R Provenza, MD principal investigator
Pontifícia Universidade Católica de Campinas, São Paulo, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing glucosamine sulfate /chondroitin sulfate - capsules, glucosamine sulfate /chondroitin sulfate - sachet and Cosamin DS® in people with Knee Osteoarthritis, run by Ache Laboratorios Farmaceuticos S.A. at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 28 exclusion criteria. 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: finished, as of the sponsor's last update on 13 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in pain intensity in the affected knee and variation of Lequesne's index and VAS at week 16 . (time frame: BASELINE, week 16). 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 13 Dec 2013.