Osteoarthritis, KneePhase 4NCT02409381
Extract of Curcuma Longa Complexed With Phosphatidilcholine(Motore®)in the Treatment of Adults With Knee Osteoarthritis
A Phase 4 study testing Motore and Alivium in people with Osteoarthritis, Knee, run by Ache Laboratorios Farmaceuticos S.A. at 1 site in Brazil.
Trial summary
Prospective, multicenter, phase IV, open, randomized, parallel, controlled, in which 288 (two hundred and eighty-eight) participants of both sexes, aged between 40 and 75 years will be randomly allocated to one of two treatment groups , and treatment group 01 will be the dried extract of Curcuma longa complexed with… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Motore and Alivium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2015to Jun 2016
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants of both sexes;
- Age greater than or equal to 40 years and less than or equal to 75 years;
- Clinical diagnosis of osteoarthritis of the knee (tibiofemoral joint) based on clinical and radiological criteria (Grade 2 and 3 Kellgren and Lawrence) as specified below:
- Pain on movement in the affected knee on most days of the last month, with at least partial relief at rest;
- Presence of osteophytes of at least 1 mm in radiological imaging, a report issued by a qualified professional from the center;
- Symptoms of osteoarthritis in the last 06 months preceding the start of the study;
- Visual Analogue Scale with 40mm or greater value (considering the data obtained at the randomization visit);
- Ability to understand and consent to participate in this clinical study, manifested by signing the Informed Consent Form (ICF).
Who cannot join
- Any finding of clinical observation (clinical and physical examination) or laboratory finding that is interpreted by the researcher as a medical risk to participation in the clinical trial;
- Any finding of ECG examination the investigator physician considers risk as to the research participant about their participation in the clinical trial;
- Known hypersensitivity to the components of the medications used during the study;
- Women in pregnancy or nursing period;
- in premenopausal women who do not agree to use acceptable contraceptive methods (oral contraceptives, injectable contraceptives, hormonal implants, barrier methods, abstinence, hormonal patch and tubal ligation); except surgically sterile (bilateral oophorectomy or hysterectomy);
- concomitant arthropathy that may confuse or interfere with pain assessment or efficacy, including: inflammatory arthropathy (rheumatoid arthritis, systemic lupus erythematosus, spondyloarthropathy, psoriatic arthritis, polymyalgia rheumatic), gouty arthritis, acute episodes of monoarthritis compatible with pseudogout, Paget's disease with involvement of the joint study, history of septic arthritis, avascular necrosis or intra-articular joint studied, Wilson's disease, hemochromatosis, alkaptonuria, primary osteochondromatosis fracture;
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- Infectious Arthritis as gonococcal and syphilitic;
- History of significant collateral ligament injury, or anterior cruciate, or the meniscus of the joint study, requiring surgery or immobilization for more than three weeks (minor ligament injuries, six months prior to the study, are not exclusion criteria );
- History of arthroscopy of the affected knee during the six months preceding the entry of the research participant in the study;
- History of any illness that, in the opinion of the investigator, might confound the results of the study or research participant put on additional risk;
- Treatment with corticosteroids as follows:
- Use of corticosteroids orally or intramuscularly for one month prior to the randomization visit (V0);
- Administration of intra-articular corticosteroid, the joint study in the previous three months at randomization visit (V0);
- Administration of intra-articular corticosteroids in any joint a visit prior to randomization (V0) month;
- intra-articular injection of hyaluronic acid in the joint or congeners studied in the last twelve months prior to randomization visit (V0);
- Implementation of any other medical treatment for osteoarthritis in the pre-randomization visit (V0) months;
- Body Mass Index (BMI) equal to or greater than 35;
- Participant that is in use Prohibited Drug;
- the presence of serious psychiatric illness of any kind that prevents the proper performance of study-related procedures and good adherence to treatment;
- Participant that has some relation to the second degree of kinship or relationship with employees or employees of Sponsor and Research Center.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial, Multicenter, Phase IV, Open, Randomized, Parallel, Controlled, Non-inferiority, to Evaluate the Efficacy and Safety of Motore® Compared to Alivium® in the Treatment of Adults With Knee Osteoarthritis
Prospective, multicenter, phase IV, open, randomized, parallel, controlled, in which 288 (two hundred and eighty-eight) participants of both sexes, aged between 40 and 75 years will be randomly allocated to one of two treatment groups , and treatment group 01 will be the dried extract of Curcuma longa complexed with phosphatidylcholine (Motore®), and treatment group 02 will ibuprofen (Alivium®).
Read the detailed description
This study evaluate the efficacy and safety of Dry Extract of Curcuma Longa complexed with phosphatidilcholine (Motore®) Compared to Ibuprofen (Alivium® ) in the treatment of adults with knee osteoarthritis. The study population will consist in participants of both sexes, aged between 40 and 80 years old with a clinical diagnosis of knee osteoarthritis (tibiofemoral joint) based on clinical and radiological criteria (Grades 2 and 3 Kellgren and Lawrence) and who had osteoarthritis symptoms in the last six (06) months preceding the start of the study. They will be randomly allocated to one of two treatment groups , and treatment group 01 will be the dried extract of Curcuma longa complexed with phosphatidylcholine (Motore®), and treatment group 02 will ibuprofen (Alivium®).
- Conditions
- Osteoarthritis, Knee
- Being tested
- Motore, Alivium
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MotoreDrug
Also called Group 1
250 mg
AliviumDrug
Also called Group 2
600 mg
| Study group | Role | What they receive |
|---|---|---|
| Motore | Experimental | Curcuma longa complexed with phosphatidylcholine - 250 mg (Motore®), two (02) capsules orally every twelve (12) hours Receives: Drug: Motore |
| Alivium | Active comparator | Ibuprofen 600 mg (Alivium®), one (01) coated tablet orally, every six (06) hours. Receives: Drug: Alivium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in the pain domain score of the WOMAC questionnaire
The primary efficacy endpoint will be the reduction in the pain domain score of the WOMAC questionnaire after 42 (forty two) days of treatment
Measured: After 42 (forty two) days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2015 (estimated)
- Study startJun 2015
- Primary completionMay 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ache Laboratorios Farmaceuticos S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Francisco Rocha, MD, Principal investigator, Artroclinica de Fortaleza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02409381
- Sponsor's protocol ID
- ACH-MTR-04(02/13)
- Status last verified
- Jun 2016
- First submitted
- 1 Apr 2015
- Last updated
- 25 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial, Multicenter, Phase IV, Open, Randomized, Parallel, Controlled, Non-inferiority, to Evaluate the Efficacy and Safety of Motore® Compared to Alivium® in the Treatment of Adults With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT02409381
- Acronym / sponsor ID
- ACH-MTR-04(02/13)
- Conditions
- Osteoarthritis, Knee
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- Ache Laboratorios Farmaceuticos S.A.Industry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 6 Apr 2015 (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.
Prospective, multicenter, phase IV, open, randomized, parallel, controlled, in which 288 (two hundred and eighty-eight) participants of both sexes, aged between 40 and 75 years will be randomly allocated to one of two treatment groups , and treatment group 01 will be the dried extract of Curcuma longa complexed with phosphatidylcholine (Motore®), and treatment group 02 will ibuprofen (Alivium®).
Detailed description
This study evaluate the efficacy and safety of Dry Extract of Curcuma Longa complexed with phosphatidilcholine (Motore®) Compared to Ibuprofen (Alivium® ) in the treatment of adults with knee osteoarthritis. The study population will consist in participants of both sexes, aged between 40 and 80 years old with a clinical diagnosis of knee osteoarthritis (tibiofemoral joint) based on clinical and radiological criteria (Grades 2 and 3 Kellgren and Lawrence) and who had osteoarthritis symptoms in the last six (06) months preceding the start of the study. They will be randomly allocated to one of two treatment groups , and treatment group 01 will be the dried extract of Curcuma longa complexed with phosphatidylcholine (Motore®), and treatment group 02 will ibuprofen (Alivium®).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motore | Experimental | Drug: MotoreCurcuma longa complexed with phosphatidylcholine - 250 mg (Motore®), two (02) capsules orally every twelve (12) hours |
| Alivium | Active comparator | Drug: AliviumIbuprofen 600 mg (Alivium®), one (01) coated tablet orally, every six (06) hours. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participants of both sexes;
- Age greater than or equal to 40 years and less than or equal to 75 years;
- Clinical diagnosis of osteoarthritis of the knee (tibiofemoral joint) based on clinical and radiological criteria (Grade 2 and 3 Kellgren and Lawrence) as specified below:
- Pain on movement in the affected knee on most days of the last month, with at least partial relief at rest;
- Presence of osteophytes of at least 1 mm in radiological imaging, a report issued by a qualified professional from the center;
Key exclusion criteria (20 listed)
- Any finding of clinical observation (clinical and physical examination) or laboratory finding that is interpreted by the researcher as a medical risk to participation in the clinical trial;
- Any finding of ECG examination the investigator physician considers risk as to the research participant about their participation in the clinical trial;
- Known hypersensitivity to the components of the medications used during the study;
- Women in pregnancy or nursing period;
- in premenopausal women who do not agree to use acceptable contraceptive methods (oral contraceptives, injectable contraceptives, hormonal implants, barrier methods, abstinence, hormonal patch and tubal ligation); except surgically sterile (bilateral oophorectomy or hysterectomy);
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 |
|---|---|---|
| MotoreAlso: Group 1250 mg | Drug | Motore |
| AliviumAlso: Group 2600 mg | Drug | Alivium |
Primary outcome
Reduction in the pain domain score of the WOMAC questionnaire
Time frame: After 42 (forty two) days of treatment
The primary efficacy endpoint will be the reduction in the pain domain score of the WOMAC questionnaire after 42 (forty two) days of treatment
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 25 Aug 2016.
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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.
Francisco Rocha, MD principal investigator
Artroclinica de Fortaleza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Motore and Alivium in people with Osteoarthritis, Knee, 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 8 inclusion and 20 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 25 Aug 2016. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Reduction in the pain domain score of the WOMAC questionnaire (time frame: After 42 (forty two) days of treatment). 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 25 Aug 2016.