Homeostec for chronic arthritis

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:

CHIKCRONTX2

Scientific title:

EVALUATION OF HOMEOSTEC INTRAVENOUS APPLICATION IN PATIENTS WITH CHRONIC MANIFESTATIONS OF CHIKUNGUNYA VIRUS INFECTION: CLINICAL TRIAL PHASE II-III

Acronym of Scientific Title:

CHIKCRONTX2

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 Cancerology State Institute 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:

Victor

Last name:

Gomez-Pichardo

Medical Specialty :

Otorhinolaryngology

Affiliation:

Naval Hospital of Manzanillo of the Navy of Mexico

Postal address:

Street Saturnino Rodriguez countless, Colonia Las Brisas

City:

Manzanillo, Colima

Country:

Mexico

Zip Code:

28210

Telephone:

+52-3143332740

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:

Mexico

Clinical sites:

Acapulco Guerrero, Naval Hospital of Acapulco of the Navy of Mexico. Maxillofacial surgeon Jorge Antonio Reynaldos del Pozo

Research ethics committees:

Cancerology State Institute of the health services of the state of Colima (SSA-Colima), March 17, 2017 (Central Ethics Committee)

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

04/12/2017

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:

Chronic arthritis for Chikungunya

Health condition(s) code:

Arthritis, Infectious

Arthritis

Chikungunya Fever

Joint Diseases

Musculoskeletal Diseases

Infection

Intervention(s):

Group I. Homeostec (experimental): Homeostec (15 ml) + Paracetamol (500 mg). The patient will receive 15 ml of intravenous Homeostec (electrolyzed solution with neutral pH) diluted in 35 ml of 0.9% saline solution (NaCl), in a slow infusion, to pass in 5 minutes. If no adverse effects occur, the procedure will be repeated at 24, 48, 72 and 96 hours. (These 5 Homeostec administrations represent a treatment cycle). In addition, you can take Paracetamol 500mg (oral) every 8 hours in case of pain due to your illness. This treatment cycle will start again at 30, 60, 90, 120 and 150 and 180 days. Group II. Paracetamol (Control): Paracetamol (500 mg). The patient will receive 500mg of Paracetamol orally every 8 hours in case of pain due to his illness and will be handled by his family doctor.

Intervention code:

Solutions

Acetaminophen

Administration, Intravenous

Infusions, Intravenous

Administration, Oral

Tablets

Intervention keyword:

Homeostec, Electrolyzed solution, Paracetamol

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):

Joint pain (analogue-numeric scale of pain). Measurement time: baseline, at 15 and 30, 60, 90, 120 and 180 days. Progression of joint disease (RAPID index 3> 12 = high, between 6.1 and 12 moderate, between 3.1 and 6 low, between 0 and 3 remission). Measurement time: baseline, at 15 and 30, 60, 90, 120 and 180 days.

Key secondary outcomes:

Adverse Events (Present, Absent. Adverse events will be categorized according to the "Common Terminology Criteria for Adverse Events" (CTCAE) version 3.). Measurement: baseline at 30, 60, 90 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 with confirmed diagnosis of Chikungunya virus infection by RT-PCR or ELISA (IgG and / or IgM anti-Chikungunya) in the previous months. 2. Age: 18 years and older. 3. Persistent musculoskeletal pain or arthritis for more than 4 weeks after onset of Chikungunya virus infection. 4. Suffering musculoskeletal or joint pain maximum on analogue-visual scale of 4 or more in the last 24hrs. 5. Acceptance in writing, prior information. 6. Women with contraceptive method with more than 90% efficacy and negative urine pregnancy test.

Exclusion criteria:

1. Rheumatoid arthritis 2. Autoimmune diseases 3. Symptomatic osteoarthritis prior to infection 4. Decompensated systemic disease 5. Creatinine 1.25 times greater than normal value or creatinine clearance less than 50 milliliters / minute (Cockfrot and Gault method). 6. Leukocytes equal to or less than 3000 cells / μL or platelet count less than 100,000 cells / μl. 7. Blood hemoglobin less than 10g / dL. 8. Increase in the last month of diastolic blood pressure to 110 mmHg or more and / or onset of hematuria or proteinuria greater than 300 milligrams / day. 9. Pseudo intestinal obstruction. Defined as abdominal pain, with airway levels on AP and lateral lateral views of the abdomen. 10. Pregnant women or women of childbearing potential without contraception: salpingoclasia, or hormonal devices. Breastfeeding women. 11. Alcoholism and / or drug addiction. 12. Known liver disease with twice the increase in liver function tests (Aspartate amino transferase (AST), Alaninoamino transferase (ALT), alkaline phosphatase, bilirubin). 13. Presence of: Cancer 14. 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:

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

Postal Address:

Avenue Patricio Sanz 1582, Colonia del Valle Centro

City:

Mexico City

Country:

Mexico

Zip Code:

03100

Telephone:

+52 55-50613500

Email :

brendapazmichel@gmail.com [4]

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:

RPCEC00000249

Date of Registration in Primary Registry:

15/08/2017

Record Verification Date:

2017/08/15

Next update date:

2018/08/15

Link to the spanish version:

Click here [5]