CholelithiasisPhase 3NCT01099319
Renalof in the Treatment of Elderly Patients With Gallstones
A Phase 3 study testing Renalof in people with Cholelithiasis, run by Catalysis SL at 1 site in Cuba.
Trial 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). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cholelithiasis
- What is being tested?
- Renalof
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCuba
- Study dates
- Jan 2010to Jun 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Confirmation of cholelithiasis by ultrasonography with or without clinical symptoms.
- Signed informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Cuba1 site
"Dr. Salvador Allende" Clinical-Surgical-Docent Hospital
Havana, La Habana
About this study
Official title: Efficacy and Safety of Renalof Administration in the Treatment of Elderly Patients With Gallstones
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.
- Conditions
- Cholelithiasis
- Being tested
- Renalof, Placebo
- Keywords
- Dietary supplement, Renalof, gallstones, elderly
- Medical subject headings
- Cholelithiasis, Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RenalofDietary supplement
One 325 mg Renalof tablet (Orally administered) every 8 hours, for 6 months.
PlaceboDietary supplement
One Placebo tablet (Orally administered) every 8 hours, for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Renalof | Experimental | Not described Receives: Dietary Supplement: Renalof |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 6 month
Secondary outcomes (2)
Presence of digestive symptoms associated with cholelithiasis
Measured: 6 month
Occurrence of adverse effects during treatment
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2010 (estimated)
- Study startJan 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholelithiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catalysis SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guillermo Hernández Mojena, MD, Principal investigator, "Dr. Salvador Allende" Clinical-Surgical-Docent Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01099319
- Sponsor's protocol ID
- CAT-1001-CU
- Status last verified
- May 2012
- First submitted
- 5 Apr 2010
- Last updated
- 8 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Renalof Administration in the Treatment of Elderly Patients With Gallstones
- ClinicalTrials.gov ID
- NCT01099319
- Acronym / sponsor ID
- CAT-1001-CU
- Conditions
- Cholelithiasis
- Keywords
- Dietary supplement, Renalof, gallstones, elderly
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Catalysis SLIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 6 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Renalof | Experimental | Dietary Supplement: Renalof |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Confirmation of cholelithiasis by ultrasonography with or without clinical symptoms.
- Signed informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RenalofOne 325 mg Renalof tablet (Orally administered) every 8 hours, for 6 months. | Dietary supplement | Renalof |
| PlaceboOne Placebo tablet (Orally administered) every 8 hours, for 6 months | Dietary supplement | Placebo |
Primary outcome
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)
Time frame: 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)
Time frame: 6 month
2 secondary outcomes
Presence of digestive symptoms associated with cholelithiasis
Time frame: 6 month
Occurrence of adverse effects during treatment
Time frame: 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillermo Hernández Mojena, MD principal investigator
"Dr. Salvador Allende" Clinical-Surgical-Docent Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Renalof in people with Cholelithiasis, run by Catalysis SL at 1 site in Cuba.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cuba. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: 6 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2012.