Benign Prostatic HyperplasiaPhase 2NCT00386009

Effects of Tadalafil Once a Day for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia

A Phase 2 study testing Tadalafil in people with Benign Prostatic Hyperplasia, run by Eli Lilly and Company at 13 sites in 3 countries.

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

The purpose of this study is to evaluate the function of the bladder and urethra during urinary storage or voiding in men with signs and symptoms of benign prostatic hyperplasia treated with either placebo or tadalafil. Read more about this study

Who is it for?: Ages 40 years and older, men only
Conditions the study is for: Benign Prostatic Hyperplasia
What is being tested?: Tadalafil
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 200 participants
Where: 13 sitesin 3 countries
Study dates: Oct 2006to May 2008
Phase: Phase 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 40 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Men 40 years of age or older with Lower Urinary Tract Symptoms (LUTS) with a total International Prostate Symptom Score (IPSS) greater than or equal to 13 at Visit 1.
Agree not to use any other approved or experimental medications for Benign Prostate Hyperplasia (BPH)-Lower Urinary Tract Symptoms, including alpha blockers, 5-alpha reductase inhibitors, PDE5 inhibitors, or herbal preparations at any time during the study.
Have not taken finasteride or dutasteride therapy for at least 4 months prior to Visit 2; have not taken any other LUTS therapy (including herbal preparations) or PDE5 inhibitors for at least 4 weeks prior to Visit 2.
Have had BPH-LUTS for greater than 6 months prior to Visit 1.

Who cannot join

Any pelvic surgical procedure on the urinary tract, including minimally invasive BPH-LUTS therapies and penile implant surgery.
History of urethral obstruction due to stricture, valves, sclerosis, or tumor.
Current neurologic disease or condition associated with neurogenic bladder (for example, Parkinson's disease, multiple sclerosis).
History of cardiac conditions including myocardial infarction, bypass surgery, angioplasty or stent placement for a specified time before starting the study.
History of angina requiring treatment with nitrates.
Prostate Specific Antigen (PSA) greater than 10 nanogram/milliliter (ng/ml) at Visit 1.

Trial locations and contacts

13 sites in 3 countries.

Country

City, postcode or hospital

13 sites in 3 countries

United States8 sites

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Chicago, Illinois, 60611
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Fort Wayne, Indiana, 46825
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Garden City, New York, 11530
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Middlebury, Connecticut, 06762
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Newport Beach, California, 92660
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Orlando, Florida, 32803
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
San Antonio, Texas, 78229
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Tarzana, California, 91356

Other trials in United States

Portugal3 sites

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Coimbra, 3000-076
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Lisbon, 1549-008
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Porto, 4200-319

Other trials in Portugal

Greece2 sites

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Pátrai, 26500
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Thessaloniki, 56429

Other trials in Greece

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multicenter Study to Evaluate the Urodynamic Effects of Tadalafil Once a Day for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia

Conditions: Benign Prostatic Hyperplasia
Being tested: Tadalafil, Placebo
Keywords: Benign Prostatic Hyperplasia, Benign Prostatic Hypertrophy
Medical subject headings: Prostatic Hyperplasia

What participants receive

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

TadalafilDrug
Also called LY450190, Cialis, IC351
20 mg tadalafil tablet taken by mouth once a day for 12 weeks.
PlaceboDrug
Placebo tablet taken by mouth once a day for 12 weeks.

Study groups in NCT00386009
Study group	Role	What they receive
1	Placebo comparator	Placebo Receives: Drug: Placebo
2	Active comparator	tadalafil Receives: Drug: Tadalafil

What is being measured

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

Change From Baseline to 12 Week Endpoint in Detrusor Pressure at Peak Urinary Flow Rate (PdetQmax)
Measured: Baseline and 12 weeks

Secondary outcomes (16)

Change From Baseline to 12 Week Endpoint in Peak Urinary Flow Rate (Qmax) Measured During Free-Flow Studies
Qmax was measured during free-flow tests using a standard calibrated flow meter.
Measured: Baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in Mean Urinary Flow Rate (Qave) Measured During Free-Flow Studies
Qave was measured during free-flow tests using a standard calibrated flow meter.
Measured: Baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in Volume of Voided Urine (Vcomp) Measured During Free-Flow Studies
Measured: Baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in Postvoid Residual Volume (PVRcath) Measured During Free-Flow Studies
PVRcath is the volume of urine remaining int he bladder after voiding, measured by catheterization.
Measured: Baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in Total Bladder Capacity Measured During Free-Flow Studies
Total bladder capacity was defined as Vcomp + PVRcath (obtained when the bladder was full).
Measured: Baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in Bladder Voiding Efficiency (BVE) Measured During Free-Flow Studies
Bladder voiding efficiency was defined as (Vcomp/total bladder capacity) X 100 (obtained when the bladder was full).
Measured: Baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in Peak Urinary Flow Rate (Qmax) Measured During Pressure-Flow Studies
Qmax was measured duirng pressure-flow tests.
Measured: Baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in Mean Urinary Flow Rate (Qave) Measured During Pressure-Flow Studies
Qave was measured during pressure-flow tests.
Measured: Baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in Volume of Voided Urine (Vcomp) Measured During Pressure-Flow Studies
Vcomp was defined as the volume of voided urine measured during pressure-flow tests.
Measured: Baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in Maximum Detrusor Pressure (Max Pdet) Measured During Pressure-Flow Studies
Max Pdet was defined as the maximum detrusor pressure observed during voiding.
Measured: Baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in Bladder Contractility Index (BCI) Measured During Pressure-Flow Studies
BCI was derived from the equation PdetQmax + 5Qmax. Scores: <100 means weak, 100-150 menas normal, >150 means strong. A decrease means a decrease in contractility of the bladder.
Measured: Baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in Bladder Outlet Obstruction Index (BOOI) Measured During Pressure-Flow Studies
BOOI, formerly known as the Abrams-Griffith number, was derived from the equation PdetQmax - 2Qmax. Scores: <20 means unobstructed, 20-40 means equivocol, >40 means obstructed. An increase means worsening of obstruction, a decreased means lessening of obstruction (improvement).
Measured: Baseline and 12 weeks
Presence of Involuntary Detrusor Contractions During Bladder Filling
Measured: Baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in Bladder Volume at First Involuntary Detrusor Contraction
Assessed in participants with involuntary detrusor contractions during the bladder filling at both baseline and endpoint.
Measured: Baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Total Score
The IPSS Total Score is obtained by combining the scores of the responses to the 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.
Measured: 12 weeks
Clinically Adverse and Statistically Significant Changes From Baseline to 12 Week Endpoint in Laboratory Tests
Laboratory tests that were statistically significant and clinically adverse would be reported for safety.
Measured: Baseline and 12 weeks

Timeline

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

Oct 2006May 2008

First posted11 Oct 2006 (estimated)
Study startOct 2006
Primary completionMay 2008
Study completionMay 2008

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.
Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00386009
Sponsor's protocol ID: 11233
Other IDs: H6D-MC-LVHK
Status last verified: Jul 2009
First submitted: 9 Oct 2006
Last updated: 9 Jul 2009
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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

Recruiting
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
Benign Prostatic Hyperplasia (BPH)
Active, not recruitingPhase 4
Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
BPH (Benign Prostatic Hyperplasia)
RecruitingObservational study
ProVIDE Studies Post Exit Analysis
BPH With Symptomatic Lower Urinary Tract Symptoms
Recruiting
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Benign Prostatic Hyperplasia With Outflow Obstruction
RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
Prostatic Hyperplasia, Benign

All Benign Prostatic Hyperplasia trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multicenter Study to Evaluate the Urodynamic Effects of Tadalafil Once a Day for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia
ClinicalTrials.gov ID: NCT00386009
Acronym / sponsor ID: 11233
Conditions: Benign Prostatic Hyperplasia
Keywords: Benign Prostatic Hyperplasia, Benign Prostatic Hypertrophy
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Collaborators: ICOS Corporation
Study start: Oct 2006
Primary completion: May 2008 (actual)
Study completion: May 2008 (actual)
First posted: 11 Oct 2006 (estimated)
Results: Posted 23 Jun 2009

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
1	Placebo comparator	Drug: PlaceboPlacebo
2	Active comparator	Drug: Tadalafiltadalafil

Who may qualify

Ages: 40 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Men 40 years of age or older with Lower Urinary Tract Symptoms (LUTS) with a total International Prostate Symptom Score (IPSS) greater than or equal to 13 at Visit 1.
Agree not to use any other approved or experimental medications for Benign Prostate Hyperplasia (BPH)-Lower Urinary Tract Symptoms, including alpha blockers, 5-alpha reductase inhibitors, PDE5 inhibitors, or herbal preparations at any time during the study.
Have not taken finasteride or dutasteride therapy for at least 4 months prior to Visit 2; have not taken any other LUTS therapy (including herbal preparations) or PDE5 inhibitors for at least 4 weeks prior to Visit 2.
Have had BPH-LUTS for greater than 6 months prior to Visit 1.

Key exclusion criteria (6 listed)

Any pelvic surgical procedure on the urinary tract, including minimally invasive BPH-LUTS therapies and penile implant surgery.
History of urethral obstruction due to stricture, valves, sclerosis, or tumor.
Current neurologic disease or condition associated with neurogenic bladder (for example, Parkinson's disease, multiple sclerosis).
History of cardiac conditions including myocardial infarction, bypass surgery, angioplasty or stent placement for a specified time before starting the study.
History of angina requiring treatment with nitrates.

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
TadalafilAlso: LY450190, Cialis, IC35120 mg tadalafil tablet taken by mouth once a day for 12 weeks.	Drug	2
PlaceboPlacebo tablet taken by mouth once a day for 12 weeks.	Drug	1

Primary outcome

Change From Baseline to 12 Week Endpoint in Detrusor Pressure at Peak Urinary Flow Rate (PdetQmax)
Time frame: Baseline and 12 weeks

16 secondary outcomes

Change From Baseline to 12 Week Endpoint in Peak Urinary Flow Rate (Qmax) Measured During Free-Flow Studies
Time frame: Baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in Mean Urinary Flow Rate (Qave) Measured During Free-Flow Studies
Time frame: Baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in Volume of Voided Urine (Vcomp) Measured During Free-Flow Studies
Time frame: Baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in Postvoid Residual Volume (PVRcath) Measured During Free-Flow Studies
Time frame: Baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in Total Bladder Capacity Measured During Free-Flow Studies
Time frame: Baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in Bladder Voiding Efficiency (BVE) Measured During Free-Flow Studies
Time frame: Baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in Peak Urinary Flow Rate (Qmax) Measured During Pressure-Flow Studies
Time frame: Baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in Mean Urinary Flow Rate (Qave) Measured During Pressure-Flow Studies
Time frame: Baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in Volume of Voided Urine (Vcomp) Measured During Pressure-Flow Studies
Time frame: Baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in Maximum Detrusor Pressure (Max Pdet) Measured During Pressure-Flow Studies
Time frame: Baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in Bladder Contractility Index (BCI) Measured During Pressure-Flow Studies
Time frame: Baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in Bladder Outlet Obstruction Index (BOOI) Measured During Pressure-Flow Studies
Time frame: Baseline and 12 weeks
Presence of Involuntary Detrusor Contractions During Bladder Filling
Time frame: Baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in Bladder Volume at First Involuntary Detrusor Contraction
Time frame: Baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Total Score
Time frame: 12 weeks
Clinically Adverse and Statistically Significant Changes From Baseline to 12 Week Endpoint in Laboratory Tests
Time frame: Baseline and 12 weeks

Results and safety

Results posted to the registry on 23 Jun 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	101	92
Tadalafil	99	89

Primary outcome: Change From Baseline to 12 Week Endpoint in Detrusor Pressure at Peak Urinary Flow Rate (PdetQmax)

Time frame: Baseline and 12 weeks. Mean (Standard Deviation). Unit: centimeters of water (cm H20)

Measure	Placebo n = 91	Tadalafil n = 84
Baseline	54.83 (27.36)	56.87 (29.67)
Change from Baseline to 12 Week Endpoint	1.92 (19.71)	-2.95 (15.92)

Placebo vs Tadalafil: p = 0.068, ANOVA

Population analysed: Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.

16 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	2 of ?	28 of ?	Not reported
Tadalafil	3 of ?	55 of ?	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2009.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Lilly Clinical Trial RegistryLink provided by the sponsor.

Related trials for Benign Prostatic Hyperplasia

Recruiting
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
Benign Prostatic Hyperplasia (BPH)
Active, not recruitingPhase 4
Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
BPH (Benign Prostatic Hyperplasia)
RecruitingObservational study
ProVIDE Studies Post Exit Analysis
BPH With Symptomatic Lower Urinary Tract Symptoms
Recruiting
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Benign Prostatic Hyperplasia With Outflow Obstruction
RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
Prostatic Hyperplasia, Benign

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.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

13 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tadalafil in people with Benign Prostatic Hyperplasia, run by Eli Lilly and Company at 13 sites in 3 countries.

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 6 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 9 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States, Portugal, Greece. 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 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 23 Jun 2009). 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?

Change From Baseline to 12 Week Endpoint in Detrusor Pressure at Peak Urinary Flow Rate (PdetQmax) (time frame: Baseline and 12 weeks). 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 NCT00386009.

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 9 Jul 2009.