NCT01099319

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 6, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

May 8, 2012

Status Verified

May 1, 2012

Enrollment Period

1.4 years

First QC Date

April 5, 2010

Last Update Submit

May 6, 2012

Conditions

Cholelithiasis

Keywords

Dietary supplementRenalofgallstoneselderly

Outcome Measures

Primary Outcomes (2)

  • 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 (2)

  • Presence of digestive symptoms associated with cholelithiasis

    6 month

  • Occurrence of adverse effects during treatment

    6 month

Study Arms (2)

Renalof

EXPERIMENTAL
Dietary Supplement: Renalof

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

RenalofDIETARY_SUPPLEMENT

One 325 mg Renalof tablet (Orally administered) every 8 hours, for 6 months.

Renalof
PlaceboDIETARY_SUPPLEMENT

One Placebo tablet (Orally administered) every 8 hours, for 6 months

Placebo

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

"Dr. Salvador Allende" Clinical-Surgical-Docent Hospital

Havana, La Habana, Cuba

Location

MeSH Terms

Conditions

CholelithiasisGallstones

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System DiseasesCholecystolithiasisGallbladder DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Guillermo Hernández Mojena, MD

    "Dr. Salvador Allende" Clinical-Surgical-Docent Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2010

First Posted

April 6, 2010

Study Start

January 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

May 8, 2012

Record last verified: 2012-05

Locations

CU(1)