Efficacy and Safety of ONCOXIN in Patients With Breast Fi... | NCT00967681

Studies
Efficacy and Safety of ONCOXIN in Patients With Breast Fibrocystic Disease

NCT00967681

Sponsor

Catalysis SL

Status

Completed

Last Update Posted

May 4, 2012Estimated

Enrollment

200Actual

Phase

Phase 3

Conditions

Breast Fibrocystic Disease

Interventions

Oncoxin
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 2012

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

Apr 2011Actual

Completion Date

Apr 2011Actual

First Submitted Date

Aug 27, 2009

First Submission Date that Met QC Criteria

Aug 27, 2009

First Posted Date

Aug 28, 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 2, 2012

Last Update Posted Date

May 4, 2012Estimated

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 evaluate whether Oncoxin, a nutritional supplement, improves the clinical and ultrasonographic results in comparison with placebo during 24 weeks of treatment.

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

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	Oncoxin, a nutritional supplement	Dietary Supplement: Oncoxin
B	Placebo Comparator		Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oncoxin	Dietary Supplement	(caplets 300 mg), three oral caplets per day for 24 weeks	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The ultrasonographic improvement at 24 weeks (end of the treatment)		24 weeks
Adverse effects at 24 weeks (end of the treatment)		24 weeks

Secondary Outcomes

Measure	Description	Time Frame
Lesion size according clinical measurement at 24 weeks (end of the treatment)		24 weeks
Pain according patient examination at 24 weeks (end of the treatment)		24 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with clinical and ultrasonographic confirmation of breast fibrocystic disease.
Patients older than 20 years.
Female patients.
Informed consent.

Exclusion Criteria:

Presents of another disease not well controlled.
Pregnant women or lactating.
Patient which are receiving another products from other investigations trials.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 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
Daisy Hernández, MD	Ramón González Coro Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
"Ramón González Coro" Gynecologic and Obstetric Hospital		Havana	La Habana	10400	Cuba

Condition Browse Module

MeSH Terms

ID	Term
D005348	Fibrocystic Breast Disease

Ancestor Terms

ID	Term
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided