D-002 and glucosamine/chondroitin sulphate in 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.

Scientific title:

PILOT STUDY COMPARING THE EFFECT OF D-002 AND CHONDROITIN SULPHATE/ GLUCOSAMINE IN PATIENTS WITH SYMPTOMS OF OSTEOARTHRITIS.

Secondary indentifying numbers:

D002/GLU-001

Issuing authority of the secondary identifying numbers:

Center of Natural Products, National Center for Scientific Research

Source(s) of monetary or material support:

Central National Center for Scientific Research 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

País:

Cuba

Zip Code:

11300

Telephone:

+53-78501000

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, 28/02/2014

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

25/03/2014

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

Intervention(s):

Group 1 (study): 1 D-002 tablet (50 mg)by oral route at breakfast time during 6 weeks Group 2 (control): 1 glucosamine/chondrointin sulphate tablet (750/250 mg) by oral route at breakfast time during 6 weeks

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 Score between health status and 96-worst health status). Measuring Time: Before starting treatment and at the end of the 1st, 2nd, 3rd, 4th, 5th and 6th weeks

Key secondary outcomes:

Pain (WOMAC questionnaire. Value between 0 and 20 points). Measuring time: At baseline, and at the end of the 1st, 2nd, 3rd, 4th, 5th and 6th weeks Stiffness (WOMAC questionnaire. Value from 0 to 8 points). Measuring time: At baseline, and at the end of the 1st, 2nd, 3rd, 4th, 5th and 6th weeks Physical Activity Survey (WOMAC questionnaire. Value between 0 and 68 points). Measuring time: At baseline, and at the end of the 1st, 2nd, 3rd, 4th, 5th and 6th weeks Pain (visual scale by analogy. Value between 0-no pain-worst 100 points dolor bearable). Measuring time: At baseline, and at the end of the 1st, 2nd, 3rd, 4th, 5th and 6th weeks Biochemical Parameters (Cholesterol (mmol/L), Triglycerides (mmol/L), HDL-C (mmol/L) ), ALT (U/L), AST(U/L), Glucose (mmol/L), Creatinine (umol/L). Measuring time: At baseline and 6th weeks Physical Status (Weight (kg), Rate (beats/min), Blood pressure (mm Hg)). Measuring time: At baseline, and at the end of the 1st, 2nd, 3rd, 4th, 5th and 6th weeks Adverse events (description (AE name), Intensity (mild, moderate, severe), causality (definitely related, probably related, possibly related, unrelated)). Measuring time: At baseline, and at the end of the 1st, 2nd, 3rd, 4th, 5th and 6th 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 yeras

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 high blood pressure 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:

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:

Sarahi

Last Name:

Mendoza Castaño

Specialty:

PhD in Pharmaceutical Sciences

Affiliation:

Center of Natural Productos, National Center for Scientific Research

Postal Address:

198 / 19 and 21, Atabey, Playa

City:

Havana

País:

Cuba

Zip Code:

11300

Telephone:

(537)2714200/2714225/2714238

Email :

sarahi.mendoza@cnic.edu.cu [1]

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:

Rosa

Middle Name:

Maria

Last Name:

Mas Ferreiro

Specialty:

PhD in Biological sciences

Affiliation:

Center of Natural Products, National Center for Scientific Research

Postal Address:

198 / 19 and 21, Atabey, Playa

City:

Havana

País:

Cuba

Zip Code:

11300

Telephone:

(537)2731522

Email :

clinica@cnic.edu.cu [2]

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:

RPCEC00000180

Date of Registration in Primary Registry:

27/06/2014

Record Verification Date:

2014/06/27

Next update date:

2015/06/27

Link to the spanish version:

Click here [3]