Efficacy of Oncoxin Plus Viusid in the Treatment of Rheum... | NCT00969527

Studies
Efficacy of Oncoxin Plus Viusid in the Treatment of Rheumatoid Arthritis

NCT00969527

Sponsor

Catalysis SL

Status

Completed

Last Update Posted

May 9, 2011Estimated

Enrollment

86Actual

Phase

Phase 3

Conditions

Rheumatoid Arthritis

Interventions

Oncoxin + Viusid
Placebo

Countries

Cuba

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Mar 2011Actual

Completion Date

Apr 2011Actual

First Submitted Date

Aug 27, 2009

First Submission Date that Met QC Criteria

Aug 31, 2009

First Posted Date

Sep 1, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 6, 2011

Last Update Posted Date

May 9, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of the study is to assess the efficacy of Oncoxin+Viusid administration in the treatment of rheumatoid arthritis. The duration of this double-blind placebo controlled phase 3 clinical trial will be 12 weeks. The estimated number of persons with rheumatoid arthritis to be recruited and randomized for the study is 86. The primary outcome measure: DAS28 score will be assessed at the end of the study.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

86Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	Oncoxin + Viusid	Dietary Supplement: Oncoxin + Viusid
B	Placebo Comparator		Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oncoxin + Viusid	Dietary Supplement	50 ml of Oncoxin + Viusid (Orally administered) twice a day, for 12 weeks.	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Disease Activity Score (DAS 28 score) at week 12.	DAS 28=(0.56√NAD+ 0.28√NAT+0.7ln⁡VSG+0.14EGE) where NAD: number of joints with pain; NAT: number of joints with increased volume; VSG: sedimentation rate of erythrocytes; EGE: Global assessment of disease by the patient on a visual analog scale (1 to 100 mm)	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Number of patients with Adverse Events at week 12		12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Treatment-naive subjects with recent onset rheumatoid arthritis
Signed informed consent

Exclusion Criteria:

Subjects with rheumatoid arthritis symptoms other than those associated with joints at disease onset
Subjects with joint function impairment secondary to other conditions not associated with rheumatoid arthritis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Juan Carlos Delgado Morales, MD	"Fructuoso Rodríguez" Orthopedic Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fructuoso Rodriguez Orthopedic Hospital		Havana		10400	Cuba

Condition Browse Module

MeSH Terms

ID	Term
D001172	Arthritis, Rheumatoid

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C551853	Viusid

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided