Extract of Curcuma Longa Complexed With Phosphatidilcholine(Motore®)in the Treatment of Adults With Knee Osteoarthritis

August 24, 2016 updated by: Ache Laboratorios Farmaceuticos S.A.

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®).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
288

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Guarulhos, São Paulo, Brazil
        • Ache Laboratorios Farmaceuticos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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;
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Motore
Curcuma longa complexed with phosphatidylcholine - 250 mg (Motore®), two (02) capsules orally every twelve (12) hours
Drug: Motore
250 mg
Other Names:
  • Group 1
Active Comparator: Alivium
Ibuprofen 600 mg (Alivium®), one (01) coated tablet orally, every six (06) hours.
Drug: Alivium
600 mg
Other Names:
  • Group 2

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
After 42 (forty two) days of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ache Laboratorios Farmaceuticos S.A.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Francisco Rocha, MD, Artroclinica de Fortaleza

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 1, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 6, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 25, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ACH-MTR-04(02/13)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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