Pulmonary HypertensionPhase 2NCT00467896

The "Power 15 Study": Safety Study of Inhalation of Ventavis With the Power Disc-15 Setting

A Phase 2 study testing Iloprost PD-6 and Iloprost PD-15 in people with Pulmonary Hypertension, run by Actelion at 12 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

A Comparison of Safety and Inhalation Times of Ventavis (iloprost) Inhalation Solution delivered by I-Neb Utilizing Power Disc-6 and Power Disc-15 "Power 15 Study" Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Pulmonary Hypertension
What is being tested?: Iloprost PD-6 and Iloprost PD-15
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 62 participants
Where: 12 sitesUnited States
Study dates: Sep 2006to Jun 2011
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 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female, aged 18-85 years
Have a current diagnosis of symptomatic pulmonary arterial hypertension (PAH) classified by one of the following: a) idiopathic pulmonary arterial hypertension (IPAH) or familial pulmonary arterial hypertension (FPAH); b) PAH associated with one of the following connective tissue diseases and mild or no lung parenchymal disease: scleroderma spectrum of disease, systemic lupus erythematosis, or mixed connective tissue disease, c) PAH associated with repaired atrial septal defect (ASD), ventricular septal defect (VSD), or patent ductus arteriosis (PDA) ≥ 1 year post-operative from Screening, d) PAH associated with human immunodeficiency virus (HIV), or e) PAH associated with the use of anorexigens (e.g. fenfluramine-phentermine)
On a stable and well tolerated dose regimen of Ventavis (5 μg per dose) for at least 4 weeks prior to the Screening visit, using the I-neb AAD System equipped with Power Disc-6

Who cannot join

Receipt of any prostacyclin or prostacyclin analogue other than Ventavis within the 12 weeks preceding the Screening visit
Receipt of atrial septostomy within the 6 months preceding Screening
History of left-sided heart disease
Clinically relevant obstructive lung disease
Chronic renal or liver disease
Uncontrolled systemic hypertension or hypotension
Cerebrovascular event within the 6 months preceding Screening

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

United States12 sites

University of Maryland Hospital
Baltimore, Maryland, 21201
Duke University Medical Center
Durham, North Carolina, 27710
Baylor College of Medicine
Houston, Texas, 77030
University of Iowa Hospital and Clinics
Iowa City, Iowa, 52242
UCSD Medical Center, Thorton Hospital
La Jolla, California, 92037
Aurora Medical Group - Cardiovascular Services
Milwaukee, Wisconsin, 53215
Ochsner Clinic Foundation
New Orleans, Louisiana, 70112
Columbia University Medical Center
New York, New York, 10032
New York Presbyterian Hospital
New York, New York, 10032
Pulmonary Associates
Phoenix, Arizona, 85006
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Diagnostic Research Group
San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: A Comparison of Safety and Inhalation Times of Ventavis (Iloprost) Inhalation Solution Delivered by I-Neb Utilizing Power Disc-6 and Power Disc-15 "Power 15 Study"

A Comparison of Safety and Inhalation Times of Ventavis (iloprost) Inhalation Solution delivered by I-Neb Utilizing Power Disc-6 and Power Disc-15 "Power 15 Study"

Conditions: Pulmonary Hypertension
Being tested: Iloprost PD-6, Iloprost PD-15
Keywords: PAH, iloprost, Ventavis, Pulmonary Arterial Hypertension, Actelion Pharmaceuticals, Cotherix
Medical subject headings: Hypertension, Pulmonary, Pulmonary Arterial Hypertension

What participants receive

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

Iloprost PD-6Drug
Also called Ventavis
Period I: Patients received iloprost administered using PD-6 for the 37 days prior to the first dosing of iloprost using PD-15. Iloprost inhalation solution was delivered using the I-neb® AAD System. Patients were required to use their own I-neb®.
Iloprost PD-15Drug
Also called Ventavis
Period II: Iloprost inhalation solution was delivered using the investigational product PD-15 with I-neb® AAD System for 37 days. Patients were required to use their own I-neb®.

Study groups in NCT00467896
Study group	Role	What they receive
Iloprost	Experimental	The study enrolled patients who were already using iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery (AAD) System with Power Disc-6 (PD-6) without any safety or tolerability concerns, thereby facilitating a direct comparison with the Power Disc-15 (PD-15). The single arm design allowed each patient to serve as his/her own control. Receives: Drug: Iloprost PD-6; Drug: Iloprost PD-15

What is being measured

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

Inhalation-times Rate - Iloprost PD-6 (Period I)
Defined as the percentage of full doses (5 µg) of iloprost delivered within the recommended time frame for receiving a full dose of iloprost (4-10 minutes). Iloprost dosing information was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full)
Measured: 37 days prior to first dose of iloprost PD-15
Inhalation-times Rate - Iloprost PD-15 (Period II)
Defined as the percentage of full doses (5 µg) of iloprost delivered within the recommended time frame for receiving a full dose of iloprost (4-10 minutes). Iloprost dosing information was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full)
Measured: 37 days following first dose of iloprost PD-15
Change in Inhalation-times Rate From Period I (Iloprost PD-6) to Period II (Iloprost PD-15)
Change in the percentage of full doses (5 µg) of iloprost delivered within the recommended time frame for receiving a full dose of iloprost (4-10 minutes). Iloprost dosing information was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full)
Measured: 37 days prior to first dose of iloprost PD-15/37 days following first dose of iloprost PD-15

Secondary outcomes (14)

Number of Daily Inhalations - Iloprost PD-6 (Period I)
Average number of daily inhalations. The number of daily inhalations was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full)
Measured: 37 days prior to first dose of iloprost PD-15
Number of Daily Inhalations - Iloprost PD-15 (Period II)
Average number of daily inhalations. The number of daily inhalations was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full)
Measured: 37 days following first dose of iloprost PD-15
Daily Inhalation Duration - Iloprost PD-6 (Period I)
Average daily inhalation duration. The inhalation duration was available from the I-neb® device, which recorded the date and time of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full)
Measured: 37 days prior to first dose of iloprost PD-15
Daily Inhalation Duration - Iloprost PD-15 (Period II)
Average daily inhalation duration. The inhalation duration was available from the I-neb® device, which recorded the date and time of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full)
Measured: 37 days following first dose of iloprost PD-15
Percentage of Complete Doses Administered - Iloprost PD-6 (Period I)
The frequency of dose completion was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full)
Measured: 37 days prior to first dose of iloprost PD-15
Percentage of Complete Doses Administered - Iloprost PD-15 (Period II)
The frequency of dose completion was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full)
Measured: 37 days following first dose of iloprost PD-15
Percentage of Daily Doses Within the 6-9 Times/Day Treatment Regimen - Iloprost PD-6 (Period I)
The frequency of daily inhalations was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full)
Measured: 37 days prior to first dose of iloprost PD-15
Percentage of Daily Doses Within the 6-9 Times/Day Treatment Regimen - Iloprost PD-15 (Period II)
The frequency of daily inhalations was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full)
Measured: 37 days following first dose of iloprost PD-15
Systolic Blood Pressure - Iloprost PD-6 (Period I)
SBP was recorded on Day 1 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-6
Measured: Day 1, prior to first dose of iloprost PD-15
Systolic Blood Pressure (SBP) - Iloprost PD-15 (Day 1 and Day 7, Period II)
SBP was recorded on Day 1 and Day 7 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-15
Measured: Day 1 and Day 7, following the first dose of iloprost PD-15
Diastolic Blood Pressure (DBP) - Iloprost PD-6 (Period I)
DBP was recorded on Day 1 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-6
Measured: Day 1, prior to first dose of iloprost PD-15
Diastolic Blood Pressure (DBP) - Iloprost PD-15 (Day 1 and Day 7, Period II)
DBP was recorded on Day 1 and Day 7 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-15
Measured: Day 1 and Day 7, following the first dose of iloprost PD-15
Heart Rate (HR) - Iloprost PD-6 (Period I)
HR was recorded on Day 1 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-6
Measured: Day 1, prior to first dose of iloprost PD-15
Heart Rate (HR) - Iloprost PD-15 (Day 1 and Day 7, Period II)
HR was recorded on Day 1 and Day 7 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-15
Measured: Day 1 and Day 7, following the first dose of iloprost PD-15

Timeline

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

Sep 2006Jun 2011

First posted1 May 2007 (estimated)
Study startSep 2006
Primary completionNov 2010
Study completionJun 2011

Why it stopped: Sponsor's decision

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 Pulmonary HypertensionStudies 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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 62 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00467896
Sponsor's protocol ID: C200-008
Status last verified: Mar 2013
First submitted: 27 Apr 2007
Last updated: 4 Apr 2013
Results posted: Yes, on ClinicalTrials.gov

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?

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Study at a glance

From the registry record, last updated by the sponsor on 4 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Comparison of Safety and Inhalation Times of Ventavis (Iloprost) Inhalation Solution Delivered by I-Neb Utilizing Power Disc-6 and Power Disc-15 "Power 15 Study"
ClinicalTrials.gov ID: NCT00467896
Acronym / sponsor ID: C200-008
Conditions: Pulmonary Hypertension
Keywords: PAH, iloprost, Ventavis, Pulmonary Arterial Hypertension, Actelion Pharmaceuticals, Cotherix
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Sponsor's decision
Enrolment: 62 participants (actual)
Lead sponsor: ActelionIndustry (pharma, biotech, devices)
Study start: Sep 2006
Primary completion: Nov 2010 (actual)
Study completion: Jun 2011 (actual)
First posted: 1 May 2007 (estimated)
Results: Posted 26 Oct 2012

Clinical summary

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

A Comparison of Safety and Inhalation Times of Ventavis (iloprost) Inhalation Solution delivered by I-Neb Utilizing Power Disc-6 and Power Disc-15 "Power 15 Study"

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Iloprost	Experimental	Drug: Iloprost PD-6, Drug: Iloprost PD-15The study enrolled patients who were already using iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery (AAD) System with Power Disc-6 (PD-6) without any safety or tolerability concerns, thereby facilitating a direct comparison with the Power Disc-15 (PD-15). The single arm design allowed each patient to serve as his/her own control.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Male or female, aged 18-85 years
Have a current diagnosis of symptomatic pulmonary arterial hypertension (PAH) classified by one of the following: a) idiopathic pulmonary arterial hypertension (IPAH) or familial pulmonary arterial hypertension (FPAH); b) PAH associated with one of the following connective tissue diseases and mild or no lung parenchymal disease: scleroderma spectrum of disease, systemic lupus erythematosis, or mixed connective tissue disease, c) PAH associated with repaired atrial septal defect (ASD), ventricular septal defect (VSD), or patent ductus arteriosis (PDA) ≥ 1 year post-operative from Screening, d) PAH associated with human immunodeficiency virus (HIV), or e) PAH associated with the use of anorexigens (e.g. fenfluramine-phentermine)
On a stable and well tolerated dose regimen of Ventavis (5 μg per dose) for at least 4 weeks prior to the Screening visit, using the I-neb AAD System equipped with Power Disc-6

Key exclusion criteria (7 listed)

Receipt of any prostacyclin or prostacyclin analogue other than Ventavis within the 12 weeks preceding the Screening visit
Receipt of atrial septostomy within the 6 months preceding Screening
History of left-sided heart disease
Clinically relevant obstructive lung disease
Chronic renal or liver disease

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
Iloprost PD-6Also: VentavisPeriod I: Patients received iloprost administered using PD-6 for the 37 days prior to the first dosing of iloprost using PD-15. Iloprost inhalation solution was delivered using the I-neb® AAD System. Patients were required to use their own I-neb®.	Drug	Iloprost
Iloprost PD-15Also: VentavisPeriod II: Iloprost inhalation solution was delivered using the investigational product PD-15 with I-neb® AAD System for 37 days. Patients were required to use their own I-neb®.	Drug	Iloprost

Primary outcome

Inhalation-times Rate - Iloprost PD-6 (Period I)
Time frame: 37 days prior to first dose of iloprost PD-15
Defined as the percentage of full doses (5 µg) of iloprost delivered within the recommended time frame for receiving a full dose of iloprost (4-10 minutes). Iloprost dosing information was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full)
Inhalation-times Rate - Iloprost PD-15 (Period II)
Time frame: 37 days following first dose of iloprost PD-15
Defined as the percentage of full doses (5 µg) of iloprost delivered within the recommended time frame for receiving a full dose of iloprost (4-10 minutes). Iloprost dosing information was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full)
Change in Inhalation-times Rate From Period I (Iloprost PD-6) to Period II (Iloprost PD-15)
Time frame: 37 days prior to first dose of iloprost PD-15/37 days following first dose of iloprost PD-15
Change in the percentage of full doses (5 µg) of iloprost delivered within the recommended time frame for receiving a full dose of iloprost (4-10 minutes). Iloprost dosing information was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full)

14 secondary outcomes

Number of Daily Inhalations - Iloprost PD-6 (Period I)
Time frame: 37 days prior to first dose of iloprost PD-15
Number of Daily Inhalations - Iloprost PD-15 (Period II)
Time frame: 37 days following first dose of iloprost PD-15
Daily Inhalation Duration - Iloprost PD-6 (Period I)
Time frame: 37 days prior to first dose of iloprost PD-15
Daily Inhalation Duration - Iloprost PD-15 (Period II)
Time frame: 37 days following first dose of iloprost PD-15
Percentage of Complete Doses Administered - Iloprost PD-6 (Period I)
Time frame: 37 days prior to first dose of iloprost PD-15
Percentage of Complete Doses Administered - Iloprost PD-15 (Period II)
Time frame: 37 days following first dose of iloprost PD-15
Percentage of Daily Doses Within the 6-9 Times/Day Treatment Regimen - Iloprost PD-6 (Period I)
Time frame: 37 days prior to first dose of iloprost PD-15
Percentage of Daily Doses Within the 6-9 Times/Day Treatment Regimen - Iloprost PD-15 (Period II)
Time frame: 37 days following first dose of iloprost PD-15
Systolic Blood Pressure - Iloprost PD-6 (Period I)
Time frame: Day 1, prior to first dose of iloprost PD-15
Systolic Blood Pressure (SBP) - Iloprost PD-15 (Day 1 and Day 7, Period II)
Time frame: Day 1 and Day 7, following the first dose of iloprost PD-15
Diastolic Blood Pressure (DBP) - Iloprost PD-6 (Period I)
Time frame: Day 1, prior to first dose of iloprost PD-15
Diastolic Blood Pressure (DBP) - Iloprost PD-15 (Day 1 and Day 7, Period II)
Time frame: Day 1 and Day 7, following the first dose of iloprost PD-15
Heart Rate (HR) - Iloprost PD-6 (Period I)
Time frame: Day 1, prior to first dose of iloprost PD-15
Heart Rate (HR) - Iloprost PD-15 (Day 1 and Day 7, Period II)
Time frame: Day 1 and Day 7, following the first dose of iloprost PD-15

Results and safety

Results posted to the registry on 26 Oct 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
Iloprost	62	11

Primary outcome: Inhalation-times Rate - Iloprost PD-6 (Period I)

Time frame: 37 days prior to first dose of iloprost PD-15. Mean (Standard Deviation). Unit: percentage of full doses administered

Measure	Iloprost PD-6 n = 45
Value	29.9 (28.75)

Population analysed: Modified intent-to-treat (MITT) population which includes all patients enrolled into the study who had at least 32 consecutive days of daily inhalation times data with PD-6, and at least 6 consecutive days of daily inhalation times data with PD-15.

Primary outcome: Inhalation-times Rate - Iloprost PD-15 (Period II)

Time frame: 37 days following first dose of iloprost PD-15. Mean (Standard Deviation). Unit: percentage of full doses administered

Measure	Iloprost PD-15 n = 45
Value	79.7 (17.45)

Primary outcome: Change in Inhalation-times Rate From Period I (Iloprost PD-6) to Period II (Iloprost PD-15)

Time frame: 37 days prior to first dose of iloprost PD-15/37 days following first dose of iloprost PD-15. Mean (Standard Deviation). Unit: percentage of full doses administered

Measure	Iloprost PD-15 n = 45
Value	49.8 (34.28)

Iloprost PD-15: Mean Difference (Net): 49.8 (95% CI 39.55 to 60.15), p <0.0001, t-test, 2 sided

14 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from baseline visit to end of study visit. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Iloprost PD-15	27 of 62 (43.5%)	53 of 62 (85.5%)	Not reported

Limitations and caveats (from the sponsor): Study was terminated early due to the discontinuation of the I-neb Power Disc-15 development program.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Michael A Mathier, MD principal investigator

University of Pittsburgh Medical Center

Ramagopal Tumuluri, MD principal investigator

Aurora Medical Group - Cardiovascular Services

Charles J. Burch, MD principal investigator

Diagnostic Research Group

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Iloprost PD-6 and Iloprost PD-15 in people with Pulmonary Hypertension, run by Actelion at 12 sites 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 3 inclusion and 7 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: stopped early, as of the sponsor's last update on 4 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites 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. 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 26 Oct 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?

Inhalation-times Rate - Iloprost PD-6 (Period I) (time frame: 37 days prior to first dose of iloprost PD-15). The study lists 3 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 NCT00467896.

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 Apr 2013.