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Usual treatment plus intra-articular application of bioactive formulation for osteoarthritis
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Comparing two revisions:
28 August 2020 - 9:19pm
by SSA
4 October 2020 - 11:53am
by SSA
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Changes to
Date of first enrollment
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2016-03-16
04
:00:00
+
2016-03-16
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:00:00
Revision of 4 October 2020 - 11:53am:
Usual treatment plus intra-articular application of bioactive formulation for osteoarthritis
General information
Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.
Acronym of Public Title:
ARTROTX-II/III
Scientific title:
Patient-reported health outcome after conservative treatment adding an intra-articular bioactive formulation for the treatment of osteoarthritis to usual medical care versus usual medical care alone: Clinical Trial Phase II/III
Acronym of Scientific Title:
ARTROTX-II/III
Secondary indentifying numbers:
Not applicable
Issuing authority of the secondary identifying numbers:
Not applicable
Primary sponsor:
Cancerology State Institute, Colima State Health Service (SSA-Colima), Mexico
Secondary sponsor:
Medical School of the University of Colima, Mexico
Source(s) of monetary or material support:
ESTERIPHARMA Foundation for Ethics, Education and Research for Cancer of the State Institute of Cancerology of Colima, A.C.
Authorization for beginning
Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.
Regulatory instance to authorize the initiation of the study:
Only approved by Ethics Committees
Principal investigator
Section to complete information about Email address, telephone number and postal address of the Principal Investigator.
First name:
Jose
Last name:
Valtierra-Alvarez
Medical Specialty :
Traumatology and orthopedics
Affiliation:
Hospital medical center "Clinica Union"
Postal address:
Avenue Enrique Corona Morfin 90, Colonia La Frontera
City:
Villa de Alvarez, Colima
Country:
Mexico
Zip Code:
28950
Telephone:
+52-3129437791
Email address:
pepe2591@hotmail.com
Clinical sites to participate
Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.
Countries of recruitment:
México
Clinical sites:
Not applicable
Research ethics committees:
Cancerology State Institute of the health services of the state of Colima (SSA-Colima), March 4th, 2016. (Central Ethics Committee)
Recruitment status
Section to complete information about the recruitment status and the date of first enrolment subject
Recruitment status:
Recruiting
Date of first enrollment:
16/03/2016
Health condition and Intervention
Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).
Health condition(s) or Problem(s) studied:
Osteoarthritis of the knee, hip, shoulder, or jaw joints
Health condition(s) code:
Osteoarthritis, Knee
Osteoarthritis, Hip
Osteoarthritis
Arthritis
Joint Diseases
Rheumatic Diseases
Musculoskeletal Diseases
Intervention(s):
Experimental group: Usual medical care plus Bioactive Formula (patent US 9089580 B1). Patients will have usual treatment prescribed by their family physician, within their routine consultations in their health system. It consists of paracetamol or/and nonsteroidal anti-inflammatory drugs use and the promotion of a healthy lifestyle. The researchers will not intervene in relation to drug prescription or lifestyle indications. Additionally, patients will receive a intra-articular application of the solution called bioactive formula in joint affected. The amount applied varies according to the joint: 2ml for knee or hip, 1.5ml for shoulder and 0.5ml for the mandibular joint. The intra-articular application is performed on an outpatient basis and it is repeated at 30 and 60 days. Control Group: Usual medical care. Patients will have usual treatment prescribed by their family physician, within their routine consultations in their health system. It consists of paracetamol or/and nonsteroidal anti-inflammatory drugs use and the promotion of a healthy lifestyle. The researchers will not intervene in relation to drug prescription or lifestyle indications.
Intervention code:
Injections, Intra-Articular
Ambulatory Surgical Procedures
Intervention keyword:
bioactive formula
Outcomes and Timepoint
Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.
Primary outcome(s):
Therapeutic efficacy: 1) Minimal Clinically Important Improvement-MCII (defined as the smallest change in measurement that signifies an important improvement in a patient’s symptom. It will be calculated through a dichotomous score per outcome, based on 30% improvement of pain from the baseline). Measurement time: baseline, at 60, 90, 180 and 360 days. 2) Patient Acceptable Symptom State-PASS (defined as the value of symptoms the patient considers to be the thresholds of well-being for pain and function. This will be assessed with the following question: “Taking into account all your daily activities, do you consider your current state satisfactory in relation to pain level and functional impairment?” The response options are “Yes” or “No”). Measurement time: baseline, at 60, 90, 180 and 360 days.
Key secondary outcomes:
1) Adverse Events (According to Common Terminology of Criteria for Adverse Events (CTCAE) version 3. Bone necrosis or tissues adjacent to the lesion, bone or muscle changes not compatible with a normal anatomy, muscle weakness, nausea, skin atrophy, ecchymosis, changes in skin pigmentation, fibrosis , alterations in the state of consciousness, pain in the area of application, neurological events, alterations in the liver enzymes or blood count, bone fracture, cardiovascular events). Measurement time: baseline, at 3, 7, 30, 60, 90, 180 and 360 days. 2) Joint space thickness (Computed axial tomography of the joint treated to assess variations in the thickness of the joint space). Measurement time: baseline, at 60 and 180 days.
Selection criterias
Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.
Gender:
Male/Female
Minimum age:
18 years
Maximum age:
None
Inclusion criteria:
1. Patients older than 18 years. 2. Patients with clinical and radiographic diagnosis of osteoarthritis in the hip, knee, shoulder or mandible. 3. Patients with severe structural damage to their joint. 4. Signature written informed consent of the patient
Exclusion criteria:
1. Rheumatoid arthritis. 2. Autoimmune diseases. 3. Decompensated systemic disease . 4. Creatinine 1.25 times the normal value or creatinine clearance less than 50 milliliters / minute (Cockfrot and Gault method). 5. Blood leucocytes less than 3000 cells / microliter or platelet count less than 100,000 / microliter. 6. Blood hemoglobin less than 10 g / deciliter. 7. Increase in the last month of diastolic blood pressure to 110 mmHg or more. 8. Hematuria or proteinuria greater than 300 milligrams/day. 9. Women who are lactating, pregnant or of childbearing age and sexually active without contraception: salpingoclasm, intrauterine device or hormonal contraceptives. This condition must be maintained for at least 6 months after the last application of the inductive bioactive formulation. 10. Alcoholism and/or drug addiction. 11. Known liver disease with twice the increase in liver function tests (Aspartate aminotransferase (AST), Alaninoamino transferase (ALT), alkaline phosphatase, bilirubin). 12. Presence of Cancer. 13. Other pathologies at the discretion of the investigator.
Type of population:
Adults
Type of participant:
Patients
Study design
Section to complete information about the characteristics of the study design.
Type study:
Interventional
Purpose:
Treatment
Allocation:
Randomized controlled trial
Masking:
Single Blind
Control group:
Active
Study design:
Parallel
Phase:
2-3
Target sample size:
230
Contact for public queries
Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status
First Name:
Ivan
Last Name:
Delgado-Enciso
Specialty:
General Medicine and Molecular Biology
Affiliation:
Cancerology State Institute, Colima State Health Service
Postal Address:
Avenue Liceo de Varones 401, Colonia La Esperanza
City:
Colima
Country:
Mexico
Zip Code:
28085
Telephone:
+52-3121521435
Email :
ivancoliman@hotmail.com
ivan_delgado_enciso@ucol.mx
Contact for scientific queries
Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.
First Name:
Juan
Last Name:
Paz-Garcia
Specialty:
Maxillofacial Surgery
Affiliation:
Hospital medical center "Clinica Union"
Postal Address:
Avenue Enrique Corona Morfin 90, Colonia La Frontera
City:
Villa de Alvarez, Colima
Country:
Mexico
Zip Code:
28950
Telephone:
+52-3123195722
Email :
dr_juanpaz@hotmail.com
Registration and Update
Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).
Primary registry:
RPCEC
Unique ID number:
RPCEC00000277
Date of Registration in Primary Registry:
11/06/2018
Record Verification Date:
2020/08/28
Next update date:
2021/08/28
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