Gastro-oesophageal RefluxPhase 4NCT00464308

A Study to Compare the Number of Patients With Gastro-Oesophageal Reflux Disease (GORD) Achieving Heartburn and Regurgitation Symptom Resolution After Treatment With Either Rabeprazole Sodium 20mg, Esomeprazole 20mg or Esomeprazole 40mg

A Phase 4 study testing Esomeprazole and Rabeprazole in people with Gastro-oesophageal Reflux, run by Janssen-Cilag Pty Ltd at 25 sites in Australia.

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 primary objective of this study is to compare, the number of patients with heartburn and regurgitation symptom resolution after treatment with either rabeprazole 20 mg, esomeprazole 20 mg or esomeprazole 40 mg. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Gastro-oesophageal Reflux
What is being tested?: Esomeprazole and Rabeprazole
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,392 participants
Where: 25 sitesAustralia
Study dates: Nov 2006to May 2008
Phase: Phase 4
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Heartburn (defined as a feeling of burning or pain, rising from the epigastrium or lower part of the chest up towards the neck) with or without regurgitation
Patients must have had episodes of heartburn with or without regurgitation for 3 months or longer, and for >= 3 days in the 7 days prior to randomisation
Able to understand and complete questionnaires, able to give written informed consent, and have access to a telephone

Who cannot join

Patients requiring endoscopy within 4 weeks of randomisation or with gastrointestinal symptoms that, in the opinion of the investigator, require further investigation prior to or coincident with initiation of PPI therapy which would include, but are not limited to, alarm symptoms such as unintentional weight loss, progressive difficulty swallowing (dysphagia), iron deficiency anaemia and epigastric mass
Significant gastrointestinal obstruction, major gastric or oesophageal surgery (excluding appendectomy or cholecystectomy), oesophageal stricture or pyloric stenosis, extra-oesophageal manifestations of reflux disease
Patients with Barrett's oesophagus (>3cm), Zollinger-Ellison Syndrome, scleroderma, malignancy (other than non-melanoma skin cancers) present within the last 5 years, hypersensitivity to rabeprazole or esomeprazole or any PPI, or any other significant condition that, in the opinion of the investigator, could interfere with the patients participation or compliance in the study such as past or current history of alcohol or drug abuse, hepatic, renal, pulmonary, respiratory abnormalities, or who have participated in an investigational drug or investigational device study within 30 days prior to the baseline visit or who are expected to do so during the 4 week study period
Female patients who are currently pregnant or breast feeding, or who, in the opinion of the investigator, may become pregnant throughout the study
Use of histamine-2 receptor antagonists (H2RAs) within 7 days of randomisation, anticholinergics, cholinergics, spasmolytics, opiates, sucralfate, proton pump inhibitors (PPIs), prokinetics, antibiotics (in relation to H. pylori treatment) or bismuth compounds within 14 days of randomisation

Trial locations and contacts

25 sites in 1 country.

City, postcode or hospital

25 sites in 1 country

Australia25 sites

Study site
Belconnen
Study site
Bondi Junction
Study site
Brookvale
Study site
Browns Plains
Study site
Campbelltown
Study site
Campsie
Study site
Caringbah
Study site
Castle Hill
Study site
Charlestown
Study site
Dapto
Study site
Darlinghurst
Study site
Dubbo
Study site
Elizabeth
Study site
Fairfield
Study site
Hoppers Crossing
Study site
Ingleburn
Study site
Leichhardt
Study site
Maroubra
Study site
Melton
Study site
Mount Druitt
Study site
Oaklands Park
Study site
Royal Park
Study site
Sydney
Study site
Wentworthville
Study site
Wyoming

Other trials in Australia

About this study

Official title: The Rabeprazole and Esomeprazole Reflux Assessment Trial (TREAT)

Read the detailed description

The study is designed to be conducted in a realistic General Practice (GP) setting, enrolling typical Gastro-oesophageal Reflux Disease (GORD) patients that present for treatment, and for whom a Proton Pump Inhibitor (PPI) would normally be prescribed. The study will be conducted over a 4-week period on the basis that current GP standard practice is to treat the GORD patient for a period of 4-weeks prior to reassessment and further follow-up if required. This study is conducted in patients with GORD - associated heartburn (with or without regurgitation) at multiple GP centers, treatment is assigned based on chance (randomized), similar to the toss of a coin and neither doctor or patient knows which treatment they will receive (double-blinded). Following screening to determine eligibility, patients will be randomized to receive oral treatment with either, 20 mg rabeprazole, 20 mg esomeprazole or 40 mg esomeprazole once daily for 4 weeks. This 4-week study encompasses 2 protocol-mandated visits (baseline on day 0 and final visit on day 28). It is hypothesized that rabeprazole 20 mg will be no less effective than (non-inferior) esomeprazole 40 mg for the degree of GORD symptom resolution. Patients will take one tablet (rabeprazole 20 mg or placebo) and one capsule (esomeprazole 20 mg, esomeprazole 40 mg or placebo) each day for 28 days. The study medication will be taken once daily in the morning before breakfast, except the first dose, which will be taken during Visit 1.

Conditions: Gastro-oesophageal Reflux
Being tested: Esomeprazole, Rabeprazole
Keywords: Gastroesophageal Reflux, Heartburn, Proton pump inhibitor, GORD
Medical subject headings: Gastroesophageal Reflux, Heartburn

What participants receive

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

EsomeprazoleDrug
20mg once daily for 28days - 1 placebo tab/cap \& 1 active tab/cap daily
RabeprazoleDrug
20mg once daily for 28days - 1 placebo tab/cap \& 1 active tab/cap daily
EsomeprazoleDrug
40mg once daily for 28days - 1 placebo tab/cap \& 1 active tab/cap daily

Study groups in NCT00464308
Study group	Role	What they receive
001	Active comparator	Esomeprazole 40mg once daily for 28days - 1 placebo tab/cap \& 1 active tab/cap daily Receives: Drug: Esomeprazole
002	Active comparator	Esomeprazole 20mg once daily for 28days - 1 placebo tab/cap \& 1 active tab/cap daily Receives: Drug: Esomeprazole
003	Active comparator	Rabeprazole 20mg once daily for 28days - 1 placebo tab/cap \& 1 active tab/cap daily Receives: Drug: Rabeprazole

What is being measured

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

The Number of Patients With Complete Resolution of Heartburn by Week 4
Complete resolution is the absence of symptoms for any 7 consecutive days within the 4 week period assessed by the PAGI-SYM scale. This likert scale describes a series of symptoms as follows: 0-None, 1-Very Mild, 2-Mild, 3-Moderate, 4-Severe, 5 Very Severe.
Measured: week 4 of treatment
The Number of Patients Achieving Complete Resolution of Regurgitation Symptoms at Week 4
Complete resolution is the absence of symptoms for any 7 consecutive days within the 4 week period assessed by the PAGI-SYM scale. This likert scale describes various symptoms as follows: 0-none, 1-Very Mild, 2-Mild, 3-Moderate, 4-Severe, 5-Very Severe.
Measured: 4 weeks
The Number of Patients Achieving Satisfactory Resolution of Heartburn by Week 4
Satisfactory resolution, which is achieved if, on any 7 consecutive days within the 4 week period, the severity of symptoms never exceeds 'mild' (symptoms must be absent, very mild, or mild) assessed by the PAGI-SYM scale. This likert scale describes various symptoms as follows: 0-none, 1-Very Mild, 2-Mild, 3-Moderate, 4-Severe, 5-Very Severe.
Measured: 4 weeks
The Number of Patients Achieving Satisfactory Resolution of Regurgitation Symptoms by Week 4
Satisfactory resolution, which is achieved if, on any 7 consecutive days within the 4 week period, the severity of symptoms never exceeds 'mild' (symptoms must be absent, very mild, or mild)assessed by the PAGI-SYM scale. This likert scale describes a series of symptoms as follows: 0-None, 1-Very Mild, 2-Mild, 3-Moderate, 4-Severe, 5 Very Severe.
Measured: 4 weeks

Secondary outcomes (3)

The Median Time to Complete Resolution of Heartburn Symptoms.
Measured: week 4 of treatment
The Median Time to Complete Relief of Regurgitation Symptoms
Measured: 4 weeks
The Mean Percentage of Participants With 24-hour Heartburn Symptom Free Periods
Measured: 4 weeks

Timeline

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

Nov 2006May 2008

First posted23 Apr 2007 (estimated)
Study startNov 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.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Gastro-oesophageal RefluxStudies 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 1,392 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00464308
Sponsor's protocol ID: CR006397
Status last verified: Apr 2014
First submitted: 20 Apr 2007
Last updated: 21 Apr 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Biscola FT, Abe CM, Guth BE. Determination of adhesin gene sequences in, and biofilm formation by, O157 and non-O157 Shiga toxin-producing Escherichia coli strains isolated from different sources. Appl Environ Microbiol. 2011 Apr;77(7):2201-8. doi: 10.1128/AEM.01920-10. Epub 2011 Feb 11.
PubMed 21317257
Eggleston A, Katelaris PH, Nandurkar S, Thorpe P, Holtmann G; Treat Study Group. Clinical trial: the treatment of gastro-oesophageal reflux disease in primary care--prospective randomized comparison of rabeprazole 20 mg with esomeprazole 20 and 40 mg. Aliment Pharmacol Ther. 2009 May 1;29(9):967-78. doi: 10.1111/j.1365-2036.2009.03948.x. Epub 2009 Feb 3.
PubMed 19210493

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

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Recruiting
SPADE Clinical Trial.
Early Gastric Cancer, Adenocarcinoma of the Stomach
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All Gastro-oesophageal Reflux trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Rabeprazole and Esomeprazole Reflux Assessment Trial (TREAT)
ClinicalTrials.gov ID: NCT00464308
Acronym / sponsor ID: CR006397
Conditions: Gastro-oesophageal Reflux
Keywords: Gastroesophageal Reflux, Heartburn, Proton pump inhibitor, GORD
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,392 participants (actual)
Lead sponsor: Janssen-Cilag Pty LtdIndustry (pharma, biotech, devices)
Study start: Nov 2006
Primary completion: May 2008 (actual)
Study completion: May 2008 (actual)
First posted: 23 Apr 2007 (estimated)
Results: Posted 30 Aug 2010

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: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
001	Active comparator	Drug: EsomeprazoleEsomeprazole 40mg once daily for 28days - 1 placebo tab/cap \& 1 active tab/cap daily
002	Active comparator	Drug: EsomeprazoleEsomeprazole 20mg once daily for 28days - 1 placebo tab/cap \& 1 active tab/cap daily
003	Active comparator	Drug: RabeprazoleRabeprazole 20mg once daily for 28days - 1 placebo tab/cap \& 1 active tab/cap daily

Who may qualify

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

Key inclusion criteria (3 listed)

Heartburn (defined as a feeling of burning or pain, rising from the epigastrium or lower part of the chest up towards the neck) with or without regurgitation
Patients must have had episodes of heartburn with or without regurgitation for 3 months or longer, and for >= 3 days in the 7 days prior to randomisation
Able to understand and complete questionnaires, able to give written informed consent, and have access to a telephone

Key exclusion criteria (5 listed)

Patients requiring endoscopy within 4 weeks of randomisation or with gastrointestinal symptoms that, in the opinion of the investigator, require further investigation prior to or coincident with initiation of PPI therapy which would include, but are not limited to, alarm symptoms such as unintentional weight loss, progressive difficulty swallowing (dysphagia), iron deficiency anaemia and epigastric mass
Significant gastrointestinal obstruction, major gastric or oesophageal surgery (excluding appendectomy or cholecystectomy), oesophageal stricture or pyloric stenosis, extra-oesophageal manifestations of reflux disease
Patients with Barrett's oesophagus (>3cm), Zollinger-Ellison Syndrome, scleroderma, malignancy (other than non-melanoma skin cancers) present within the last 5 years, hypersensitivity to rabeprazole or esomeprazole or any PPI, or any other significant condition that, in the opinion of the investigator, could interfere with the patients participation or compliance in the study such as past or current history of alcohol or drug abuse, hepatic, renal, pulmonary, respiratory abnormalities, or who have participated in an investigational drug or investigational device study within 30 days prior to the baseline visit or who are expected to do so during the 4 week study period
Female patients who are currently pregnant or breast feeding, or who, in the opinion of the investigator, may become pregnant throughout the study
Use of histamine-2 receptor antagonists (H2RAs) within 7 days of randomisation, anticholinergics, cholinergics, spasmolytics, opiates, sucralfate, proton pump inhibitors (PPIs), prokinetics, antibiotics (in relation to H. pylori treatment) or bismuth compounds within 14 days of randomisation

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
Esomeprazole20mg once daily for 28days - 1 placebo tab/cap \& 1 active tab/cap daily	Drug	002
Rabeprazole20mg once daily for 28days - 1 placebo tab/cap \& 1 active tab/cap daily	Drug	003
Esomeprazole40mg once daily for 28days - 1 placebo tab/cap \& 1 active tab/cap daily	Drug	001

Primary outcome

The Number of Patients With Complete Resolution of Heartburn by Week 4
Time frame: week 4 of treatment
Complete resolution is the absence of symptoms for any 7 consecutive days within the 4 week period assessed by the PAGI-SYM scale. This likert scale describes a series of symptoms as follows: 0-None, 1-Very Mild, 2-Mild, 3-Moderate, 4-Severe, 5 Very Severe.
The Number of Patients Achieving Complete Resolution of Regurgitation Symptoms at Week 4
Time frame: 4 weeks
Complete resolution is the absence of symptoms for any 7 consecutive days within the 4 week period assessed by the PAGI-SYM scale. This likert scale describes various symptoms as follows: 0-none, 1-Very Mild, 2-Mild, 3-Moderate, 4-Severe, 5-Very Severe.
The Number of Patients Achieving Satisfactory Resolution of Heartburn by Week 4
Time frame: 4 weeks
Satisfactory resolution, which is achieved if, on any 7 consecutive days within the 4 week period, the severity of symptoms never exceeds 'mild' (symptoms must be absent, very mild, or mild) assessed by the PAGI-SYM scale. This likert scale describes various symptoms as follows: 0-none, 1-Very Mild, 2-Mild, 3-Moderate, 4-Severe, 5-Very Severe.
The Number of Patients Achieving Satisfactory Resolution of Regurgitation Symptoms by Week 4
Time frame: 4 weeks
Satisfactory resolution, which is achieved if, on any 7 consecutive days within the 4 week period, the severity of symptoms never exceeds 'mild' (symptoms must be absent, very mild, or mild)assessed by the PAGI-SYM scale. This likert scale describes a series of symptoms as follows: 0-None, 1-Very Mild, 2-Mild, 3-Moderate, 4-Severe, 5 Very Severe.

3 secondary outcomes

The Median Time to Complete Resolution of Heartburn Symptoms.
Time frame: week 4 of treatment
The Median Time to Complete Relief of Regurgitation Symptoms
Time frame: 4 weeks
The Mean Percentage of Participants With 24-hour Heartburn Symptom Free Periods
Time frame: 4 weeks

Results and safety

Results posted to the registry on 30 Aug 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Rabeprazole 20 mg/Day	464	395
Esomeprazole 40 mg/Day	469	406
Esomeprazole 20 mg/Day	459	400

Primary outcome: The Number of Patients With Complete Resolution of Heartburn by Week 4

Time frame: week 4 of treatment. Number. Unit: participants

Measure	Rabeprazole 20 mg/Day n = 464	Esomeprazole 40 mg/Day n = 469	Esomeprazole 20 mg/Day n = 459
Value	272	302	278

Rabeprazole 20 mg/Day vs Esomeprazole 40 mg/Day: Proportion difference: -0.11, p <0.05, Non-inferiority

Population analysed: The intent-to-treat (ITT) population was used for all efficacy analyses. The data were reanalysed using the compliance population (defined as all subjects who consumed at least 80% of study medication and who completed at least 80% of data recording).

Primary outcome: The Number of Patients Achieving Complete Resolution of Regurgitation Symptoms at Week 4

Time frame: 4 weeks. Number. Unit: participants

Measure	Rabeprazole 20 mg/Day n = 464	Esomeprazole 40 mg/Day n = 469	Esomeprazole 20 mg/Day n = 459
Value	281	283	276

Rabeprazole 20 mg/Day vs Esomeprazole 40 mg/Day: Proportion difference: -0.051, p <0.05, non-inferiority

Primary outcome: The Number of Patients Achieving Satisfactory Resolution of Heartburn by Week 4

Time frame: 4 weeks. Number. Unit: participants

Measure	Rabeprazole 20 mg/Day n = 464	Esomeprazole 40 mg/Day n = 469	Esomeprazole 20 mg/Day n = 459
Value	405	418	414

Rabeprazole 20 mg/Day vs Esomeprazole 40 mg/Day: Proportion difference: -0.053, p <0.05, non-inferiority

Population analysed: Symptom scores 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, 5=very severe

Primary outcome: The Number of Patients Achieving Satisfactory Resolution of Regurgitation Symptoms by Week 4

Time frame: 4 weeks. Number. Unit: participants

Measure	Rabeprazole 20 mg/Day n = 464	Esomeprazole 40 mg/Day n = 469	Esomeprazole 20 mg/Day n = 459
Value	397	413	402

Rabeprazole 20 mg/Day vs Esomeprazole 40 mg/Day: Proportion difference: -0.061, p <0.05, non-inferiority

3 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
Rabeprazole 20 mg/Day	5 of 464 (1.1%)	151 of 464 (32.5%)	Not reported
Esomeprazole 40 mg/Day	1 of 469 (0.2%)	155 of 469 (33%)	Not reported
Esomeprazole 20 mg/Day	9 of 459 (2%)	158 of 459 (34.4%)	Not reported

Limitations and caveats (from the sponsor): The MCID of 7.5% was amended to 9% to maintain power with smaller sample size.The proportion of patients without heartburn symptoms at baseline was not evenly distributed between treatment arms. This was a significant predictor of symptom resolution.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 21317257Biscola FT, Abe CM, Guth BE. Determination of adhesin gene sequences in, and biofilm formation by, O157 and non-O157 Shiga toxin-producing Escherichia coli strains isolated from different sources. Appl Environ Microbiol. 2011 Apr;77(7):2201-8. doi: 10.1128/AEM.01920-10. Epub 2011 Feb 11.
Derived from this study: PubMed 19210493Eggleston A, Katelaris PH, Nandurkar S, Thorpe P, Holtmann G; Treat Study Group. Clinical trial: the treatment of gastro-oesophageal reflux disease in primary care--prospective randomized comparison of rabeprazole 20 mg with esomeprazole 20 and 40 mg. Aliment Pharmacol Ther. 2009 May 1;29(9):967-78. doi: 10.1111/j.1365-2036.2009.03948.x. Epub 2009 Feb 3.

Related trials for Gastro-oesophageal Reflux

Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Recruiting
SPADE Clinical Trial.
Early Gastric Cancer, Adenocarcinoma of the Stomach
Enrolling by invitation
Endoscopic Treatment of Gastroesophageal Reflux Disease
Gastro Esophageal Reflux Disease
Enrolling by invitationObservational study
Assessment of Esophageal Epithelium Integrity With Use of a Novel Mucosal Impedance Device
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RecruitingObservational study
Efficacy and Safety of Esomeprazole 40 mg IV in Post-Surgical Patients Admitted to the ICU
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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.

Janssen-Cilag Pty Ltd Clinical Trial study director

Janssen-Cilag Pty Ltd

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Esomeprazole and Rabeprazole in people with Gastro-oesophageal Reflux, run by Janssen-Cilag Pty Ltd at 25 sites in Australia.

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 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 21 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in Australia. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 30 Aug 2010). 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?

The Number of Patients With Complete Resolution of Heartburn by Week 4 (time frame: week 4 of treatment). The study lists 4 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 NCT00464308, 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 21 Apr 2014.