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

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:

dr_juanpaz@hotmail.com [1]

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 Formulation (patents US 9089580 B1 and US 9669074 B2). 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 formulation into affected joint. 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 60 and 120 days for one subgroup or after 30 and 60 days, for another subgroup. 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 (VAS, WOMAC, Clinical Rasmussen, RAPID3). It will be calculated through a dichotomous score per outcome, based on 30% improvement from the baseline). Measurement time: baseline, at 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 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 30, 90, 180 and 360 days. 2) Change in anti-inflammatory non steroidal drugs use. Measurement time: baseline, at 90, 180 and 360 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:

350

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 [2]

ivan_delgado_enciso@ucol.mx [3]

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:

Brenda

Middle Name:

Astrid

Last Name:

Paz-Michel

Specialty:

Biomedical Research

Affiliation:

Esteripharma SA de CV

Postal Address:

Patricio Sanz 1582 Del Valle, Benito Juárez

City:

México City

Country:

Mexico

Zip Code:

03100

Telephone:

+52-5550613500

Email :

brendapazmichel@gmail.com [4]

About study completion

Section to complete the data related to the study completion.

Study completion date:

02/10/2023

Date of available results:

01/10/2024

Date of first publication:

13/03/2019

Results Study

Section to complete the data related to the summarized results.

Results file:

Phase III and Phase II.pdf [5]

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:

2020/10/04

Next update date:

2021/10/04

Link to the spanish version:

Click here [6]