Prevenox on 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:

Effects of Prevenox (D-003) on symptoms of osteoarthritis

Secondary indentifying numbers:

D-003/06

Issuing authority of the secondary identifying numbers:

Center of Natural Products, Nacional Center for Scientific Researchs

Source(s) of monetary or material support:

Nacional Center for Scientific Researchs 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 Rodríguez

Medical Specialty :

2nd degree on orthopedia

Affiliation:

Surgical Medical Research Centre (CIMEQ)

Postal address:

216 st and 11B st, Siboney, Playa

City:

Havana

Country:

Cuba

Zip Code:

11300

Telephone:

+53-78581000

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:

CIMEQ, December 7th, 2011

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

14/02/2012

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 symptoms

Intervention(s):

Control Group: Placebo of Prevenox 2 oral tablets daily for 6 weeks at breakfast. Study Group: Prevenox 2 oral tablets (5mg each) daily for 6 weeks at breakfast. Subjects who did not improve symptoms at 3 weeks of treatment doses were doubled to four tablets daily (20 mg / d or placebo), two at breakfast and two at meal times.

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 Questionnaire(WOMAC. 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 Analogy Scale- VAS-. Value between 0-no pain-worst 100 points bearable pain). Measuring time:at baseline and at the end of the 1st, 2nd, 3rd, 4th, 5th and 6th weeks Adverse events (description (name of the event), intensity (mild-moderate, severe), causality (definitely related, probably related, possibly related, not related)). Measuring time: 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 years

Maximum age:

80 years

Inclusion criteria:

1. Subjects of both sexes 2. aged between 20 and 80 years 3. Subjects with symptoms of OA (joint pain in hip, spine, limbs and / or phalanges) 4. Subjects who signed the informed consent. 5. Subjects who qualified in Scales I-III of the American Association of Rheumatology 6. Subjects who had a WOMAC scale score ≥ 30.

Exclusion criteria:

1. Existence of other forms of arthritis, 2. Arthroplasty or orthopedic surgery in the last three years 3. Transplanted 4. Subjects with active liver or kidney disease 5. Neoplasms diagnosed, 6. Severe hypertension 7. Diabetes mellitus uncompensated 8. Hospitalization for any cause in the previous 6 months, 9. Subjects with fasting glucose> 7 mmol / L 10. Subjects with usual clinical history of allergy to drugs 11. Subjects with any other special condition that jeopardize 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:

Double Blind

Control group:

Placebo

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:

Pharmaeutical Siences, PhD

Affiliation:

Center of Natural Products, Nacional Center for Scientific Researchs

Postal Address:

198 st /19 and 21, Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

11300

Telephone:

+537-2714225

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:

María

Last Name:

Mas Ferreiro

Specialty:

Biological Sciences, PhD

Affiliation:

Center of Natural Products, Nacional Center for Scientific Researchs

Postal Address:

198 st / 19 and 21, Atabey, Playa

City:

Havana

Country:

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).

Unique ID number:

RPCEC00000170

Date of Registration in Primary Registry:

20/09/2013

Record Verification Date:

2013/09/20

Next update date:

2014/09/20

Link to the spanish version:

Click here [3]