Renalof in the Treatment of Elderly Patients With Gallstones | NCT01099319

Studies
Renalof in the Treatment of Elderly Patients With Gallstones

NCT01099319

Sponsor

Catalysis SL

Status

Completed

Last Update Posted

May 8, 2012Estimated

Enrollment

40Actual

Phase

Phase 3

Conditions

Cholelithiasis

Interventions

Renalof
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

Jan 2010

Primary Completion Date

Jun 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

Apr 5, 2010

First Submission Date that Met QC Criteria

Apr 5, 2010

First Posted Date

Apr 6, 2010Estimated

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, 2012

Last Update Posted Date

May 8, 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 this study is to assess the efficacy and safety of Renalof administration in the treatment of gallstones (cholelithiasis) as determined by ultrasonography and clinical evaluation in elderly patients (aged >65 years). The duration of this double-blind placebo controlled phase 3 clinical trial will be 6 months. The estimated number of patients to be recruited and randomized for the study is 40.

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

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Renalof	Experimental		Dietary Supplement: Renalof
Placebo	Placebo Comparator		Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Renalof	Dietary Supplement	One 325 mg Renalof tablet (Orally administered) every 8 hours, for 6 months.	Renalof

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Size of calculi at month 0 and 6 (month 0 refers to the beginning of treatment and month 6 refers to the end of the treatment)		6 month
Number of calculi at month 0 and 6 (month 0 refers to the beginning of treatment and month 6 refers to the end of the treatment)		6 month

Secondary Outcomes

Measure	Description	Time Frame
Presence of digestive symptoms associated with cholelithiasis		6 month
Occurrence of adverse effects during treatment		6 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Confirmation of cholelithiasis by ultrasonography with or without clinical symptoms.
Signed informed consent

Exclusion Criteria:

Previous surgical intervention for the treatment of cholelithiasis
Cholelithiasis with acute symptoms requiring emergency surgery
Cholelithiasis associated with neoplastic condition of any localization or origin
Usage of other antioxidants within the duration of the clinical trial
Handicap and/or psychiatric condition preventing treatment accomplishment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Guillermo Hernández Mojena, MD	"Dr. Salvador Allende" Clinical-Surgical-Docent Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
"Dr. Salvador Allende" Clinical-Surgical-Docent Hospital		Havana	La Habana		Cuba

Condition Browse Module

MeSH Terms

ID	Term
D002769	Cholelithiasis
D042882	Gallstones

Ancestor Terms

ID	Term
D001660	Biliary Tract Diseases
D004066	Digestive System Diseases
D041761	Cholecystolithiasis
D005705	Gallbladder Diseases

Browse Leaves

Not provided

Browse Branches

Not provided