Abexol and Glucosamine/Chondroitin Sulphate in osteoarthritis: study of the 6 months.

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:

A/G-02

Scientific title:

Study of the effects of Abexol (D-002) and the Glucosamine/Chondroitin Sulphate in subjects with symptoms of osteoarthritis: study of the 6 months.

Acronym of Scientific Title:

Abe/Glu-02

Secondary indentifying numbers:

Abe/Glu-02

Issuing authority of the secondary identifying numbers:

Center of Natural Products, National Center for Scientific Research

Source(s) of monetary or material support:

National Center for Scientific Research Central Account for BioCubaFarma

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:

Roberto

Midle name:

Antonio

Last name:

Puente Rodriguez

Medical Specialty :

2nd Degree Specialist in Orthopedics

Affiliation:

Surgical Medical Research Center

Postal address:

216 and 11-B, Siboney, Playa

City:

Havana

Country:

Cuba

Zip Code:

12100

Telephone:

+53-78501000

Email address:

roberto.puente@infomed.sld.cu

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:

Cuba

Clinical sites:

Not applicable

Research ethics committees:

Surgical Medical Research Center, June 1th, 2016

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

15/01/2017

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:

Osteoarthritis

Health condition(s) code:

Osteoarthritis

Arthritis

Joint Diseases

Rheumatic Diseases

Musculoskeletal Diseases

Intervention(s):

Group 1 (Experimental): An Abexol tablet (50 mg) by oral route at breakfast time during 6 months. Group 2 (Control): A Glucosamine/Chondrointin Sulphate tablet (375/300 mg) by oral route at breakfast time during 6 months.

Intervention code:

Chondroitin Sulfates

Glucosamine

Dietary Supplements

Tablets

Administration, Oral

Intervention keyword:

Abexol, D-002, purified extract of beeswax

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):

Health Status (WOMAC questionnaire 0-Best health status, 96-worst health status). Measuring Time: At baseline, at the end of the 6, 12, 18 and 24 weeks.

Key secondary outcomes:

Pain (WOMAC questionnaire. Value between 0 and 20 points). Measuring time: At baseline, at the end of the 1st, 2nd, 3rd, 4th, 5th and 6th weeks. Stiffness (WOMAC questionnaire. Value between 0 and 8 points). Measuring time: At baseline, at the end of the 6, 12, 18 and 24 weeks. Physical Activity Survey (WOMAC questionnaire. Value between 0 and 68 points). Measuring time: At baseline, at the end of the 6, 12, 18 and 24 weeks. Pain (Visual Analogue Scale. Value between 0-no pain-100 points-Worst pain bearable). Measuring time: At baseline, at the end of the 6, 12, 18 and 24 weeks. Segurity and tolerability: Physical status (weight (kg), rate (beats/min), blood pressure (mm Hg)). Measuring time: At baseline, at the end of the 6, 12, 18 and 24 weeks. Biochemistry tests (laboratory values). Measuring time: At baseline, at the end of the 12 and 24 weeks. Adverse Events (description (AE name), intensity (mild, moderate, severe), causality relationship (definitely related, probably related, possibly related, unrelated)). Measuring time: At the end of the 6, 12, 18 and 24 weeks.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

20 years

Maximum age:

80 years

Inclusion criteria:

1. Women and men. 2. Ages between 20 and 80 years. 3. With symptoms of OA (joint pain in hip, spine, limbs and / or phalanges). 4. Which have agreed to give informed consent. 5. Patients classified in Scales I-III of the American Association of Rheumatology. 6. Patients with WOMAC score > 25.

Exclusion criteria:

1. Existence of other forms of arthritis. 2. Arthroplasty in the last 3 years. 3. Any orthopedic surgery in the last 3 years. 4. Transplanted. 5. Active liver disease or active kidney disease. 6. Neoplasms diagnosed. 7. Severe arterial hypertension 8. Uncompensated diabetes mellitus (fasting glucose > 7 mmol/L). 9. Hospitalization for any cause in the previous 6 months. 10. Subjects with normal clinical history of allergy to any other medicines or other special conditions that endanger their health and their lives during the study.

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:

Open

Control group:

Active

Study design:

Parallel

Phase:

4

Target sample size:

60

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:

Julio

Middle Name:

Cesar

Last Name:

Fernández Travieso

Specialty:

PhD in Pharmaceutical Sciences

Affiliation:

Center of Natural Products, National Center for Scientific Research

Postal Address:

198 /19 and 21, Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

11300

Telephone:

+537-2085834

Email :

julio.fernandez@cnic.edu.cu

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:

Sarahi

Last Name:

Mendoza Castaño

Specialty:

PhD in Pharmaceutical Scienes

Affiliation:

Center of Natural Products, National Center for Scientific Research

Postal Address:

198 / 19 and 21, Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

11300

Telephone:

+5372711654

Email :

sarahi.mendoza@cnic.edu.cu

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:

RPCEC00000222

Date of Registration in Primary Registry:

02/12/2016

Record Verification Date:

2016/12/02

Next update date:

2017/12/02

Link to the spanish version:

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Abexol and Glucosamine/Chondroitin Sulphate in osteoarthritis: study of the 6 months.

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