Revisions for Prevenox on osteoarthritis | Registro Público Cubano de Ensayos Clínicos

--- 31 December 1969 - 8:00pm by Anónimo
+++ 20 September 2013 - 3:08pm by CPN
+Prevenox on osteoarthritis
+Only approved by Ethics Committees
+Not entered
+-00-00 00:00:00
+Cuba
+-00-00 00:00:00
+In process
+Not applicable
+CIMEQ, December 7th, 2011
+Complete
+-02-14 05:00:00
+Roberto
+Antonio
+Osteoarthritis symptoms
+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
+Puente Rodríguez
+nd degree on orthopedia
+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.
+Surgical Medical Research Centre (CIMEQ)
+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.
+st and 11B st, Siboney, Playa
+Male/Female
+Havana
+years
+Cuba
+years
+. Subjects of both sexes
+. aged between 20 and 80 years
+. Subjects with symptoms of OA (joint pain in hip, spine, limbs and / or phalanges)
+. Subjects who signed the informed consent.
+. Subjects who qualified in Scales I-III of the American Association of Rheumatology
+. Subjects who had a WOMAC scale score ≥ 30.
+. Existence of other forms of arthritis,
+. Arthroplasty or orthopedic surgery in the last three years
+. Transplanted
+. Subjects with active liver or kidney disease
+. Neoplasms diagnosed,
+. Severe hypertension
+. Diabetes mellitus uncompensated
+. Hospitalization for any cause in the previous 6 months,
+. Subjects with fasting glucose> 7 mmol / L
+. Subjects with usual clinical history of allergy to drugs
+. Subjects with any other special condition  that jeopardize their health and their lives during the study.
+Interventional
+Adults
+Patients
+Treatment
+Randomized controlled trial
+Double Blind
+Placebo
+Parallel
+Sarahi
+Mendoza Castaño
+Pharmaeutical Siences, PhD
+Center of Natural Products, Nacional Center for Scientific Researchs
+st /19 and 21, Atabey, Playa
+Havana
+Cuba
++537-2714225
+Rosa
+María
+Mas Ferreiro
+Biological Sciences, PhD
+Center of Natural Products, Nacional Center for Scientific Researchs
+st / 19 and 21, Atabey, Playa
+Havana
+Cuba
++537 2731522
+RPCEC00000170
+/09/2013
+/09/20
+/09/20
+<a href="/ensayos/RPCEC00000170-Sp">Click here</a>
+Effects of Prevenox (D-003) on symptoms of osteoarthritis
+D-003/06
+Center of Natural Products, Nacional Center for Scientific Researchs
+Center of Natural Products, Nacional Center for Scientific Researchs
+Not applicable
+Nacional Center for Scientific Researchs
+BIOCUBAFARMA

31 December 1969 - 8:00pm by Anónimo

20 September 2013 - 3:08pm by CPN

Changes to Public title

Prevenox on osteoarthritis

Changes to Regulatory instance to authorize the initiation of the study

Only approved by Ethics Committees

Changes to Regulatory instance

Not entered

Changes to Other regulatory instances

Changes to Notification date

0000-00-00 00:00:00

Changes to Countries of recruitment

Cuba

Changes to Authorization date

0000-00-00 00:00:00

Changes to Reference number

In process

Changes to Clinical sites

Not applicable

Changes to Research ethics committees

CIMEQ, December 7th, 2011

Changes to Recruitment status

Complete

Changes to Data sharing plan

Changes to Date of first enrollment

2012-02-14 05:00:00

Changes to Description of Data Sharing Plan

Changes to First name

Roberto

Changes to Additional information to share

Changes to URL for additional information

Changes to Midle name

Antonio

Changes to Health condition(s) or Problem(s) studied

Osteoarthritis symptoms

Changes to 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

Changes to Last name

Puente Rodríguez

Changes to Health condition(s) code

Changes to Name of Research Ethics Committees

Changes to Medical Specialty

2nd degree on orthopedia

Changes to 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.

Changes to Health condition keyword

Changes to Status of evaluation

Changes to Affiliation

Surgical Medical Research Centre (CIMEQ)

Changes to 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.

Changes to Status of evaluation date of Ethic Committee

Changes to Postal address

216 st and 11B st, Siboney, Playa

Changes to Intervention code

Changes to Postal address of Ethic Committee

Changes to Intervention keyword

Changes to Gender

Male/Female

Changes to City

Havana

Changes to Telephone

Changes to Minimum age

20 years

Changes to Country

Cuba

Changes to Zip Code

11300

Changes to Maximum age

80 years

Changes to Email

Changes to Telephone

Changes to URL for Ethics Committees

Changes to 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.

Changes to 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.

Changes to Final enrolment number

Changes to Email address

Changes to Type study

Interventional

Changes to Type of population

Adults

Changes to Study completion date

Changes to Type of participant

Patients

Changes to Purpose

Treatment

Changes to Date of available results

Changes to Other purpose

Changes to Date of first publication

Changes to Allocation

Randomized controlled trial

Changes to Masking

Double Blind

Changes to Control group

Placebo

Changes to Study design

Parallel

Changes to Other design

Changes to Phase

Changes to Target sample size

Changes to First Name

Sarahi

Changes to Middle Name

Changes to Last Name

Mendoza Castaño

Changes to Specialty

Pharmaeutical Siences, PhD

Changes to Affiliation

Center of Natural Products, Nacional Center for Scientific Researchs

Changes to Postal Address

198 st /19 and 21, Atabey, Playa

Changes to City

Havana

Changes to Country

Cuba

Changes to Zip Code

11300

Changes to Telephone

+537-2714225

Changes to Telephone

Changes to Email

Changes to First Name

Rosa

Changes to Middle Name

María

Changes to Last Name

Mas Ferreiro

Changes to Specialty

Biological Sciences, PhD

Changes to Affiliation

Center of Natural Products, Nacional Center for Scientific Researchs

Changes to Postal Address

198 st / 19 and 21, Atabey, Playa

Changes to City

Havana

Changes to Country

Cuba

Changes to Zip Code

11300

Changes to Telephone

+537 2731522

Changes to Telephone (Contact for Scientific Queries)

Changes to Email

Changes to Primary registry

Changes to Unique ID number

RPCEC00000170

Changes to Date of Registration in Primary Registry

20/09/2013

Changes to Record Verification Date

2013/09/20

Changes to Next update date

2014/09/20

Changes to Link to the spanish version

<a href="/ensayos/RPCEC00000170-Sp">Click here</a>

Changes to Acronym of Public Title

Changes to Scientific title

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

Changes to Acronym of Scientific Title

Changes to Secondary indentifying numbers

D-003/06

Changes to Issuing authority of the secondary identifying numbers

Center of Natural Products, Nacional Center for Scientific Researchs

Changes to Primary sponsor

Center of Natural Products, Nacional Center for Scientific Researchs

Changes to Secondary sponsor

Not applicable

Changes to Source(s) of monetary or material support

Nacional Center for Scientific Researchs

BIOCUBAFARMA

Changes to Participant flow

Changes to Baseline characteristics

Changes to Outcome measures

Changes to Adverse events

Changes to Summary study

Changes to Url for Results File

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):

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

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

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

Registered Trials

Registration process

Prevenox on osteoarthritis

About the RPCEC

Useful resources