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

NCT02409381 | Completed Phase 4

• 1 other identifier: ACH-MTR-04(02/13)
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 1

Brief 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 phosphatidylcholine (Motore®), and treatment group 02 will ibuprofen (Alivium®).

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• 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

  After 42 (forty two) days of treatment

Study Arms (2)

Motore

EXPERIMENTAL

Curcuma longa complexed with phosphatidylcholine - 250 mg (Motore®), two (02) capsules orally every twelve (12) hours

Drug: Motore

Alivium

ACTIVE COMPARATOR

Ibuprofen 600 mg (Alivium®), one (01) coated tablet orally, every six (06) hours.

Drug: Alivium

Interventions

Motore DRUG

250 mg

Also known as: Group 1

Motore

Alivium DRUG

600 mg

Also known as: Group 2

Alivium

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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 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;

Sponsors & Collaborators

• Ache Laboratorios Farmaceuticos S.A.: lead

Study Sites (1)

Ache Laboratorios Farmaceuticos

Guarulhos, São Paulo, Brazil

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Francisco Rocha, MD

  Artroclinica de Fortaleza

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2015
• First Posted: April 6, 2015
• Study Start: June 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: June 1, 2016
• Last Updated: August 25, 2016

Record last verified: 2016-06

Locations

BR (1)