CystinuriaPhase 1/2NCT00381849

Use of an Herbal Preparation to Prevent and Dissolve Kidney Stones

A Phase 1/2 study testing Cystone in people with Cystinuria and Nephrolithiasis, Calcium Oxalate, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 100 years
Conditions the study is for: Cystinuria, Nephrolithiasis, Calcium Oxalate
What is being tested?: Cystone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 20 participants
Where: 1 siteUnited States
Study dates: Apr 2006to Jun 2010
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 100 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Written informed consent In the cystine arm, all patients will have the diagnosis of cystinuria, made on the basis of a 24-hour urine cystine containing more than 1500 umol of cystine, or a stone compositional analysis of cystine
Presence of an existing cystine stone in one or both kidneys In the calcium arm, all patients will have a history of a calcium stone as determined by laboratory analysis.
Medically effective birth control if fertile female
Able to comply with protocol

Who cannot join

Pregnant
Subjects under age 18 years
Obstructing stones
Urinary Tract Infection that cannot be cleared with single course of antibiotic
Subjects who decline to provide informed consent

Trial locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic
Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Cystone for Treatment of Nephrolithiasis

We will investigate the safety and effectiveness of a mixture of 9 east Indian herbs known as Cystone regarding their ability to dissolve existing kidney stones and prevent formation of new ones. Cystine and calcium stone formers will be recruited for a 59 week trial. The first phase of the study will be two 6 weeks periods during which each subject will receive Cystone or placebo in random order (with a one-week wash out between 6 week treatment periods). The remaining 46 weeks, each subject will receive Cystone. End points are changes in urinary chemistries and stone burden by Computerized Tomography (CT) scanning.

Read the detailed description

Cystone will be used in proven cystine and calcium stone forming adults who are not pregnant. Subjects must have a measurable stone by CT. The first phase is a double blind, randomized, placebo controlled cross-over of Cystone and placebo for 6 weeks each separated by a 1 week washout. Entry, 6 and 12 week 24 hour urine supersaturations or cystine, pH and sodium determinations will be collected. Then all patients enter an open label phase of 46 weeks, ensuring a 52-week total exposure to Cystone during the 59 week study. Baseline and 1 year stone quantification CT scans will be performed. End points will be changes in urine chemistry/supersaturation and stone burden. Stone burden was measured by CT, quantitatively for stone density and volume. All CT images were also reviewed in a blinded fashion by a radiologist to score each kidney as increased, no change or decreased stone burden.

Statistics and Randomization: Randomization was accomplished using a table provided by the department of statistics to the study coordinator who was blinded as to whether the patients received placebo or Cystone®. Biochemical and supersaturation results were analyzed via a matched pair analysis using the JMP software package (SAS Instituted, Inc.); P values < 0.05 were deemed significant.

Conditions: Cystinuria, Nephrolithiasis, Calcium Oxalate
Being tested: Cystone, Sugar Pill (Placebo)
Keywords: Cystone, Uricare, Computerized tomography, Kidney calculi, Supersaturation, Nephrolithiasis, Quantitative CT
Medical subject headings: Cystinuria, Nephrolithiasis, Calcium Oxalate, Kidney Calculi, Nephrolithiasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CystoneDrug
Also called Uricare
Participants will take 2 pills, 2 times a day.
Each tablet of Cystone contains:
Shilapushpha (Didymocarpus pedicellata) 130 mg, Pasanabheda (Saxifraga ligulata Syn. Bergenia ligulata/cilata) 98 mg, Indian madder/ Manjishtha (Rubia cordifolia) 32 mg, Umbrella's edge/ Nagarmusta (Cyperus scariosus) 32 mg, Prickly chaff flower/ Apamarga (Achyranthes aspera) 32 mg, Sedge/ Gojiha (Onosma bracteatum) 32 mg, Purple fleabane/ Sahadeve (Veronoia Cinerea) 32 mg, Lime silicate calx/ Hajrul yahood Bhasma/ Badrashma bhasma) 32 mg, Shilajit 26 mg.
Sugar Pill (Placebo)Drug
Participants will take 2 pills, 2 times a day for 6 weeks.

Study groups in NCT00381849
Study group	Role	What they receive
Cystone then sugar pill	Active comparator	Subject will take Cystone for 6 weeks, then have a 1 week wash out period followed by the sugar pill for another 6 weeks Receives: Drug: Cystone; Drug: Sugar Pill (Placebo)
Sugar pill then Cystone	Placebo comparator	Subject will take sugar pill for 6 weeks, then a 1 week wash out followed by the Cystone for another 6 weeks Receives: Drug: Cystone; Drug: Sugar Pill (Placebo)
Open-label Cystone	Experimental	All subjects will receive Cystone for 46 weeks in the open-label period. Receives: Drug: Cystone

What is being measured

The primary outcome is the main question the study is designed to answer.

24 Hour Urine Supersaturation of Calcium Oxalate (CaOx)
Urine is often supersaturated, which favors precipitation of crystalline phases such as calcium oxalate. However, crystals do not always form in supersaturated urine because supersaturation is balanced by crystallization inhibitors that are also present. Supersaturation is calculated by measuring the concentration of all the ions that can interact. Once these concentrations are known, a computer program can calculate the theoretical supersaturation with respect to the important crystalline phases, eg, calcium oxalate.
Measured: baseline, after 6 weeks treatment on placebo, after 6 weeks treatment on cystone, at end of 46 weeks of open label cystone treatment
24 Hour Urine Supersaturation of Calcium Phosphate (Brushite)
Urine is often supersaturated, which favors precipitation of crystalline phases such as calcium oxalate. However, crystals do not always form in supersaturated urine because supersaturation is balanced by crystallization inhibitors that are also present. Supersaturation is calculated by measuring the concentration of all the ions that can interact. Once these concentrations are known, a computer program can calculate the theoretical supersaturation with respect to the important crystalline phases, eg, calcium oxalate.
Measured: baseline, after 6 weeks treatment on placebo, after 6 weeks treatment on cystone, at end of 46 weeks of open label cystone treatment
24 Hour Urine Supersaturation of Calcium Phosphate (Hydroxyapatite)
Urine is often supersaturated, which favors precipitation of crystalline phases such as calcium oxalate. However, crystals do not always form in supersaturated urine because supersaturation is balanced by crystallization inhibitors that are also present. Supersaturation is calculated by measuring the concentration of all the ions that can interact. Once these concentrations are known, a computer program can calculate the theoretical supersaturation with respect to the important crystalline phases, eg, calcium oxalate.
Measured: baseline, after 6 weeks treatment on placebo, after 6 weeks treatment on cystone, at end of 46 weeks of open label cystone treatment
24 Hour Urinary Cystine Excretion
Measured: baseline, after 6 weeks treatment on placebo, after 6 weeks treatment on cystone, at end of 46 weeks of open label cystone treatment
Stone Density as Measured by Agatston Score Via Computerized Tomography
Agatston results are a measure of calcium typically used for measuring coronary artery calcification.
Measured: Baseline, approximately 52 weeks after baseline
Volume of Kidney Stones as Measured on Computerized Tomography
Measurement of kidney stone volume in cubic millimeters.
Measured: Baseline, approximately 52 weeks after baseline

Secondary outcomes (1)

Change in Stone Burden as Assessed by Radiologist at One Year
Stone burden will be quantitated using the stone quantification protocol currently available at Mayo that quantitates kidney stones both by volume and by density measured in Agatston units.
Measured: Baseline, approximately 52 weeks after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2006Jun 2010

First posted28 Sep 2006 (estimated)
Study startApr 2006
Primary completionSep 2009
Study completionJun 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for CystinuriaStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe sponsor's other registered studies.
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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00381849
Sponsor's protocol ID: 2115-05
Other IDs: P50DK083007
Status last verified: Jan 2016
First submitted: 27 Sep 2006
Last updated: 4 Feb 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Abdollahiasl A, Kebriaeezadeh A, Nikfar S, Farshchi A, Ghiasi G, Abdollahi M. Patterns of antibiotic consumption in Iran during 2000-2009. Int J Antimicrob Agents. 2011 May;37(5):489-90. doi: 10.1016/j.ijantimicag.2011.01.022. Epub 2011 Mar 17. No abstract available.
PubMed 21419606
Erickson SB, Vrtiska TJ, Canzanello VJ, Lieske JC. Cystone(R) for 1 year did not change urine chemistry or decrease stone burden in cystine stone formers. Urol Res. 2011 Jun;39(3):197-203. doi: 10.1007/s00240-010-0334-x. Epub 2010 Dec 16.
PubMed 21161651

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Prospective Research Rare Kidney Stones (ProRKS)
Hyperoxaluria, Cystinuria
RecruitingObservational study
Rare Kidney Stone Consortium Biobank
Primary Hyperoxaluria, Dent Disease
RecruitingObservational study
Rare Kidney Stone Consortium Patient Registry
Primary Hyperoxaluria, Dent Disease
RecruitingObservational study
Monogenic Kidney Stone - Genetic Testing
Rare Kidney Stone Diseases
Active, not recruiting
Randall's Plaque Study: Pathogenesis and Relationship to Nephrolithiasis
Nephrocalcinosis, Renal Calculi

All Cystinuria trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cystone for Treatment of Nephrolithiasis
ClinicalTrials.gov ID: NCT00381849
Acronym / sponsor ID: 2115-05
Conditions: Cystinuria, Nephrolithiasis, Calcium Oxalate
Keywords: Cystone, Uricare, Computerized tomography, Kidney calculi, Supersaturation, Nephrolithiasis, Quantitative CT
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Collaborators: Himalaya Herbal Healthcare, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: Apr 2006
Primary completion: Sep 2009 (actual)
Study completion: Jun 2010 (actual)
First posted: 28 Sep 2006 (estimated)
Results: Posted 6 Aug 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Cystone then sugar pill	Active comparator	Drug: Cystone, Drug: Sugar Pill (Placebo)Subject will take Cystone for 6 weeks, then have a 1 week wash out period followed by the sugar pill for another 6 weeks
Sugar pill then Cystone	Placebo comparator	Drug: Cystone, Drug: Sugar Pill (Placebo)Subject will take sugar pill for 6 weeks, then a 1 week wash out followed by the Cystone for another 6 weeks
Open-label Cystone	Experimental	Drug: CystoneAll subjects will receive Cystone for 46 weeks in the open-label period.

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Written informed consent In the cystine arm, all patients will have the diagnosis of cystinuria, made on the basis of a 24-hour urine cystine containing more than 1500 umol of cystine, or a stone compositional analysis of cystine
Presence of an existing cystine stone in one or both kidneys In the calcium arm, all patients will have a history of a calcium stone as determined by laboratory analysis.
Medically effective birth control if fertile female
Able to comply with protocol

Key exclusion criteria (5 listed)

Pregnant
Subjects under age 18 years
Obstructing stones
Urinary Tract Infection that cannot be cleared with single course of antibiotic
Subjects who decline to provide informed consent

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
CystoneAlso: UricareParticipants will take 2 pills, 2 times a day. Each tablet of Cystone contains: Shilapushpha (Didymocarpus pedicellata) 130 mg, Pasanabheda (Saxifraga ligulata Syn. Bergenia ligulata/cilata) 98 mg, Indian madder/ Manjishtha (Rubia cordifolia) 32 mg, Umbrella's edge/ Nagarmusta (Cyperus scariosus) 32 mg, Prickly chaff flower/ Apamarga (Achyranthes aspera) 32 mg, Sedge/ Gojiha (Onosma bracteatum) 32 mg, Purple fleabane/ Sahadeve (Veronoia Cinerea) 32 mg, Lime silicate calx/ Hajrul yahood Bhasma/ Badrashma bhasma) 32 mg, Shilajit 26 mg.	Drug	Cystone then sugar pill, Open-label Cystone, Sugar pill then Cystone
Sugar Pill (Placebo)Participants will take 2 pills, 2 times a day for 6 weeks.	Drug	Cystone then sugar pill, Sugar pill then Cystone

Primary outcome

24 Hour Urine Supersaturation of Calcium Oxalate (CaOx)
Time frame: baseline, after 6 weeks treatment on placebo, after 6 weeks treatment on cystone, at end of 46 weeks of open label cystone treatment
Urine is often supersaturated, which favors precipitation of crystalline phases such as calcium oxalate. However, crystals do not always form in supersaturated urine because supersaturation is balanced by crystallization inhibitors that are also present. Supersaturation is calculated by measuring the concentration of all the ions that can interact. Once these concentrations are known, a computer program can calculate the theoretical supersaturation with respect to the important crystalline phases, eg, calcium oxalate.
24 Hour Urine Supersaturation of Calcium Phosphate (Brushite)
Time frame: baseline, after 6 weeks treatment on placebo, after 6 weeks treatment on cystone, at end of 46 weeks of open label cystone treatment
Urine is often supersaturated, which favors precipitation of crystalline phases such as calcium oxalate. However, crystals do not always form in supersaturated urine because supersaturation is balanced by crystallization inhibitors that are also present. Supersaturation is calculated by measuring the concentration of all the ions that can interact. Once these concentrations are known, a computer program can calculate the theoretical supersaturation with respect to the important crystalline phases, eg, calcium oxalate.
24 Hour Urine Supersaturation of Calcium Phosphate (Hydroxyapatite)
Time frame: baseline, after 6 weeks treatment on placebo, after 6 weeks treatment on cystone, at end of 46 weeks of open label cystone treatment
Urine is often supersaturated, which favors precipitation of crystalline phases such as calcium oxalate. However, crystals do not always form in supersaturated urine because supersaturation is balanced by crystallization inhibitors that are also present. Supersaturation is calculated by measuring the concentration of all the ions that can interact. Once these concentrations are known, a computer program can calculate the theoretical supersaturation with respect to the important crystalline phases, eg, calcium oxalate.
24 Hour Urinary Cystine Excretion
Time frame: baseline, after 6 weeks treatment on placebo, after 6 weeks treatment on cystone, at end of 46 weeks of open label cystone treatment
Stone Density as Measured by Agatston Score Via Computerized Tomography
Time frame: Baseline, approximately 52 weeks after baseline
Agatston results are a measure of calcium typically used for measuring coronary artery calcification.
Volume of Kidney Stones as Measured on Computerized Tomography
Time frame: Baseline, approximately 52 weeks after baseline
Measurement of kidney stone volume in cubic millimeters.

1 secondary outcome

Change in Stone Burden as Assessed by Radiologist at One Year
Time frame: Baseline, approximately 52 weeks after baseline

Results and safety

Results posted to the registry on 6 Aug 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Calcium Stone Subjects	10	10
Cystine Stone Subjects	10	10

Primary outcome: 24 Hour Urine Supersaturation of Calcium Oxalate (CaOx)

Time frame: baseline, after 6 weeks treatment on placebo, after 6 weeks treatment on cystone, at end of 46 weeks of open label cystone treatment. Mean (Standard Deviation). Unit: KJoules/mol

Measure	Calcium Stone Subjects n = 10	Cystine Stone Subjects n = 0
CaOx at Baseline	1.83 (0.28)	–
CaOx after placebo (6 wks)	1.83 (0.42)	–
CaOx after Cystone (6 wks)	1.87 (0.43)	–
CaOx at end of Cystone (46 weeks)	1.78 (0.47)	–

Calcium Stone Subjects: p = 0.32, t-test, 1 sided
Calcium Stone Subjects: p = 0.23, t-test, 1 sided
Calcium Stone Subjects: p = 0.41, t-test, 1 sided

Population analysed: CaOx was not analyzed for the Cystine Stone subjects.

Primary outcome: 24 Hour Urine Supersaturation of Calcium Phosphate (Brushite)

Time frame: baseline, after 6 weeks treatment on placebo, after 6 weeks treatment on cystone, at end of 46 weeks of open label cystone treatment. Mean (Standard Deviation). Unit: KJoules/mol

Measure	Calcium Stone Subjects n = 10	Cystine Stone Subjects n = 0
Brushite at Baseline	0.35 (1.04)	–
Brushite after placebo (6 wks)	0.73 (0.83)	–
Brushite after Cystone (6 wks)	0.38 (0.98)	–
Brushite at end of Cystone (46 weeks)	0.09 (1.29)	–

Calcium Stone Subjects: p = 0.49, t-test, 1 sided
Calcium Stone Subjects: p = 0.64, t-test, 1 sided
Calcium Stone Subjects: p = 0.72, t-test, 1 sided

Population analysed: Brushite was not analyzed for the Cystine Stone subjects.

Primary outcome: 24 Hour Urine Supersaturation of Calcium Phosphate (Hydroxyapatite)

Time frame: baseline, after 6 weeks treatment on placebo, after 6 weeks treatment on cystone, at end of 46 weeks of open label cystone treatment. Mean (Standard Deviation). Unit: KJoules/mol

Measure	Calcium Stone Subjects n = 10	Cystine Stone Subjects n = 0
Hydroxyapatite at Baseline	4.25 (2.02)	–
Hydroxyapatite after placebo (6 wks)	5.03 (1.23)	–
Hydroxyapatite after Cystone (6 wks)	4.65 (1.86)	–
Hydroxyapatite at end of Cystone (46 weeks)	4.09 (2.06)	–

Population analysed: Hydroxyapatite was not analyzed for the Cystine Stone subjects.

Primary outcome: 24 Hour Urinary Cystine Excretion

Time frame: baseline, after 6 weeks treatment on placebo, after 6 weeks treatment on cystone, at end of 46 weeks of open label cystone treatment. Mean (Standard Deviation). Unit: mcmol/24 hours

Measure	Calcium Stone Subjects n = 0	Cystine Stone Subjects n = 10
Cystine at Baseline	–	2770 (947)
Cystine after placebo (6 wks)	–	3183 (1898)
Cystine after Cystone (6 wks)	–	2948 (2021)
Cystine at end of Cystone (46 weeks)	–	4140 (2398)

Cystine Stone Subjects: p = 0.69, t-test, 1 sided
Cystine Stone Subjects: p = 0.25, t-test, 1 sided
Cystine Stone Subjects: p = 0.15, t-test, 1 sided

Population analysed: Cystine excretion was not applicable to the Calcium Stone subjects.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Calcium Stone Subjects	0 of 10 (0%)	0 of 10 (0%)	Not reported
Cystine Stone Subjects	0 of 10 (0%)	0 of 10 (0%)	Not reported

Limitations and caveats (from the sponsor): There were no serious adverse events and no adverse events. Power of the study was diminished by failure of patients to return all required 24 hour urine samples. The botanical authenticity of Cystone was not documented.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 21419606Abdollahiasl A, Kebriaeezadeh A, Nikfar S, Farshchi A, Ghiasi G, Abdollahi M. Patterns of antibiotic consumption in Iran during 2000-2009. Int J Antimicrob Agents. 2011 May;37(5):489-90. doi: 10.1016/j.ijantimicag.2011.01.022. Epub 2011 Mar 17. No abstract available.
Results publication: PubMed 21161651Erickson SB, Vrtiska TJ, Canzanello VJ, Lieske JC. Cystone(R) for 1 year did not change urine chemistry or decrease stone burden in cystine stone formers. Urol Res. 2011 Jun;39(3):197-203. doi: 10.1007/s00240-010-0334-x. Epub 2010 Dec 16.

Related trials for Cystinuria

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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.

Stephen B. Erickson, M.D. principal investigator

Mayo Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Cystone in people with Cystinuria and Nephrolithiasis, Calcium Oxalate, run by Mayo Clinic at 1 site in United States.

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 4 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 4 Feb 2016. 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 United States. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

24 Hour Urine Supersaturation of Calcium Oxalate (CaOx) (time frame: baseline, after 6 weeks treatment on placebo, after 6 weeks treatment on cystone, at end of 46 weeks of open label cystone treatment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00381849, which also lists 2 linked publications.

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 4 Feb 2016; AzTrials last refreshed its copy on 26 Oct 2026.