Ankylosing SpondylitisPhase 4LoadetNCT00873730
Study Evaluating Etanercept in Subjects With Ankylosing Spondylitis in Spain
A Phase 4 study testing etanercept in people with Ankylosing Spondylitis, run by Wyeth is now a wholly owned subsidiary of Pfizer.
Trial summary
The purpose of this study was to evaluate efficacy and safety of etanercept 100 mg (50 mg twice a week) compared with 50 mg once a week in adult subjects with ankylosing spondylitis (AS) and previous failure to usual practice therapies in Spain. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ankylosing Spondylitis
- What is being tested?
- etanercept
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- Dec 2006to Jun 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of ankylosing spondylitis, as defined by Modified New York Criteria for Ankylosing Spondylitis.
- Maintained inflammatory activity for more than 12 weeks defined by:·Axial forms: BASDAI higher than or equal to 4 (0-10) and at least one of the following parameters:. Global assessment of the disease by the patient higher than or equal to 4 (On a scale 0-10). Spinal pain higher than or equal to 4 on a visual analogue scale (VAS). Increase in erythrocyte sedimentation rate (ESR) and/or CRP above the normality parameters established by the laboratory.·Peripheral forms: Arthritis or enthesitis higher than or equal to 1 site and at least one of the following:. Global assessment of the disease by the patient higher than or equal to 4 (on a scale 0-10). Increase in erythrocyte sedimentation rate (ESR) and/or CRP above the normality parameters established by the laboratory
- Failure to treatment: Failure to at least 2 NSAIDs at maximum recommended dose during at least 3 months (or a shorter time in case of intolerance, toxicity or contraindication).·In cases of ankylosing spondylitis with peripheral joint involvement, salazopyrine should have been used at a dose of 2-3 g per day and/or methotrexate (15 mg/week) for 4 months (or a shorter time in case of intolerance, toxicity or contraindication). In case of oligoarticular or localized involvement in enthesis: lack of response, at the discretion of the investigator, to local infiltrations and/or synoviorthesis.
- Be between 18-70 years of age
- Negative result of a pregnancy test in serum in screening visit and in urine in baseline visit, done in all women, except those surgically sterilized and those who have at least one year of menopause.
- Sexually active women of childbearing potential must use medically acceptable contraceptive methods, including oral, injectable or implantable contraceptive methods, intrauterine devices or properly used barrier contraception. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant. This includes women who are using contraceptives or whose sexual partners are either sterile or using contraceptives.
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- Men who are not surgically sterile should agree to use reliable contraceptive methods during the study.
- Ability to reconstitute the drug and self-inject it or have a person who can do so.
- Capability to understand and voluntarily give written informed consent that is signed and dated, before any specific procedure of the protocol is performed.
- Ability to store injectable test article at 2º to 8º C.
Who cannot join
- Contraindications for treatment with anti-TNF
- Complete ankylosis of spine
- Onset of treatment with DMARDs in the 4 weeks prior to baseline (SSZ, MTX and HCQ are permitted if the administrated dose has been maintained stable in the 4 weeks prior to baseline). Furthermore, patients with a dose of prednisone >10 mg/d or equivalent or modified in the 2 weeks prior to the baseline visit, those in whose infiltration has been performed with intraarticular corticosteroids has been performed in the 4 weeks prior to the screening visit and those who follow treatment with more than one NSAID in the 2 weeks prior to the baseline visit are excluded.
- Previous treatment with other TNF inhibitors and other biological drugs
- Abnormalities in hematology profiles defined by:
- leukocytes lower than or equal to 3.5 x 10 exponent 9 /L
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- hemoglobin lower than or equal to 8.5 g/L or 5.3 mmol/L
- hematocrit lower than or equal to 27%
- platelets lower than or equal to 125 x 10 exponent 9 /L
- serum creatinine higher than or equal to 175 mmol/L
- aspartate aminotransferase and alanine aminotransferase higher than or equal to 2 times the upper limit of normality
- Important concomitant medical conditions, such as:-Class III or IV congestive heart failure according to New York Heart Association classification-Uncontrolled arterial hypertension (defined as screening systolic blood pressure > 160 mm Hg or screening diastolic blood pressure > 100 mm Hg)-Myocardial infarction within 12 months of the screening visit or unstable angina-Severe pulmonary disease requiring hospitalization or oxygen therapy-Diagnosis of multiple sclerosis or other central nervous system demyelinating disease -Presence or history of confirmed blood dyscrasias-Cancer or history of cancer (other than resected cutaneous basal cell or squamous cell carcinoma)-Serious infection (infection requiring hospitalization and/or intravenous antibiotics) within 1 month of administration of test article administration or active infection at screening or history of recurrent or chronic infection-Open cutaneous ulcers-Patients with known chronic infections as positivity to HIV, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) -Active tuberculosis infection (local guidelines for appropriate screening and treatment of tuberculosis in the setting of anti-TNF therapy must be followed)- Any condition that, in the investigator's judgment, might cause this study to be detrimental to the subject
- Pregnant or breast-feeding women
- Past or current psychiatric illness that would interfere with the subject's ability to comply with protocol requirements or give informed consent.
- Treatment with any live (attenuated) vaccine within 4 weeks prior to baseline.
- History of alcohol or drug abuse that would interfere with the subject's ability to comply with protocol requirements.
- Treatment with any investigational drug within 3 months of screening visit.
About this study
Official title: A 12-week Randomized, Double-blind, Multicenter Pilot Study to Evaluate the Effect of Etanercept 100 mg and 50 mg Weekly in Subjects With Ankylosing Spondylitis
The purpose of this study was to evaluate efficacy and safety of etanercept 100 mg (50 mg twice a week) compared with 50 mg once a week in adult subjects with ankylosing spondylitis (AS) and previous failure to usual practice therapies in Spain.
- Conditions
- Ankylosing Spondylitis
- Being tested
- etanercept, etanercept/placebo
- Keywords
- Effect of etanercept in subjects with ankylosing spondylitis
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etanerceptDrug
Etanercept 50 mg twice a week (BIW) for 12 weeks
etanercept/placeboDrug
Etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: etanercept |
| 2 | Active comparator | Not described Receives: Drug: etanercept/placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 20.
ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients. ASAS = 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement (vs. baseline) and an absolute change ≥ 10 units on a 0-100 scale (0=no disease activity; 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.
Measured: 12 weeks
Secondary outcomes (15)
Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 40.
ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients. ASAS = 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement (vs. baseline) and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.
Measured: 12 weeks
Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 50.
ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients. ASAS = 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 50 = 50% improvement (vs. baseline) and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.
Measured: 12 weeks
Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 70.
ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients. ASAS = 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 70 = 70% improvement (vs. baseline) and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.
Measured: 12 weeks
Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 5/6.
ASAS 5/6 consists of 6 domains: the 4 used in ASAS 20 (patient global assessment of disease activity, pain, function, inflammation measured on a 0-100 scale, where 0=no disease activity, 100=high disease activity) plus spinal mobility and an acute phase reactant, C Reactive Protein (CRP). Achieving ASAS 5/6 requires a 20% improvement compared to baseline in ≥ 5 domains and no worsening in the remaining domain.
Measured: 12 weeks
Number of Patients Achieving Partial Remission.
Partial remission defined as a score of less than 20 units (on a scale of 0-100, where 0=no disease activity, 100=high disease activity) in each of the 4 Assessment in Ankylosing Spondylitis (ASAS) domains: patient global assessment of disease activity, pain, function, and inflammation. For scale, 100=high disease activity.
Measured: 12 weeks
Change in Nocturnal Back and Overall Spinal Pain From Baseline to Week 12.
Nocturnal back and overall spinal pain assessed by patients using a Visual Analog Scale (VAS) of 0 - 10 (0 = no pain and 10 = most severe pain).
Measured: Baseline and 12 weeks
Change in Physician and Patient Global Assessment (PGA) of Pain From Baseline to Week 12.
Patient pain assessed by physician and patient using a Visual Analog Scale (VAS) of 0 - 10 (0 = none and 10 = severe).
Measured: Baseline and 12 weeks
Change in Bath Ankylosing Spondylitis Functional Index (BASFI) From Baseline to Week 12.
BASFI is a validated self assessment tool that determines the degree of functional limitation in AS patients. Utilizing a VAS of 0-10 (0=easy, 10=impossible), patients answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.
Measured: Baseline and 12 weeks
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) From Baseline to Week 12.
BASDAI is a validated self assessment tool used to determine disease activity in patients with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) patient's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI final mean score was calculated taking all 6 VAS assessments.
Measured: Baseline and 12 weeks
Change in Bath Ankylosing Spondylitis Metrology Index (BASMI) From Baseline to Week 12.
BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.
Measured: Baseline and 12 weeks
Change in Erythrocyte Sedimentation Rate (ESR) From Baseline to Week 12.
ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube and is measured in mm/hour. Normal range is 0-30mm/h. A higher rate is consistent with inflammation.
Measured: Baseline and 12 weeks
Ankylosing Spondylitis Quality of Life (EuroQoL) Questionnaire
EuroQol questionnaire is intended to measure the quality of life by means of questions about mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Answers to every question were grouped in two main categories: with problems (having some problems or absolutely unable) or without problems.
Measured: 12 weeks
Change in 36-Item Short-Form Health Survey (SF-36) From Baseline to Week 12.
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Measured: Baseline and 12 weeks
Improvement of Ocular Inflammatory Disease in Patients With Baseline Symptoms
Measured: 12 weeks
Change in C-reactive Protein (CRP) From Baseline to Week 12.
CRP is a marker of inflammation and measured in mg/l. A higher level is consistent with inflammation.
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.
- First posted2 Apr 2009 (estimated)
- Study startDec 2006
- Primary completionJun 2008
- Study completionJun 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 (1)Papers the sponsor has linked to this study.
- Other trials for Ankylosing SpondylitisStudies 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
- Double blind
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00873730
- Sponsor's protocol ID
- 0881A3-406
- Acronym
- Loadet
- Status last verified
- Apr 2010
- First submitted
- 1 Apr 2009
- Last updated
- 28 Apr 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Navarro-Sarabia F, Fernandez-Sueiro JL, Torre-Alonso JC, Gratacos J, Queiro R, Gonzalez C, Loza E, Linares L, Zarco P, Juanola X, Roman-Ivorra J, Martin-Mola E, Sanmarti R, Mulero J, Diaz G, Armendariz Y, Collantes E. High-dose etanercept in ankylosing spondylitis: results of a 12-week randomized, double blind, controlled multicentre study (LOADET study). Rheumatology (Oxford). 2011 Oct;50(10):1828-37. doi: 10.1093/rheumatology/ker083. Epub 2011 Jun 23.
PubMed 21700683
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-week Randomized, Double-blind, Multicenter Pilot Study to Evaluate the Effect of Etanercept 100 mg and 50 mg Weekly in Subjects With Ankylosing Spondylitis
- ClinicalTrials.gov ID
- NCT00873730
- Acronym / sponsor ID
- Loadet / 0881A3-406
- Conditions
- Ankylosing Spondylitis
- Keywords
- Effect of etanercept in subjects with ankylosing spondylitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 2 Apr 2009 (estimated)
- Results
- Posted 13 Aug 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to evaluate efficacy and safety of etanercept 100 mg (50 mg twice a week) compared with 50 mg once a week in adult subjects with ankylosing spondylitis (AS) and previous failure to usual practice therapies in Spain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: etanercept |
| 2 | Active comparator | Drug: etanercept/placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Diagnosis of ankylosing spondylitis, as defined by Modified New York Criteria for Ankylosing Spondylitis.
- Maintained inflammatory activity for more than 12 weeks defined by:·Axial forms: BASDAI higher than or equal to 4 (0-10) and at least one of the following parameters:. Global assessment of the disease by the patient higher than or equal to 4 (On a scale 0-10). Spinal pain higher than or equal to 4 on a visual analogue scale (VAS). Increase in erythrocyte sedimentation rate (ESR) and/or CRP above the normality parameters established by the laboratory.·Peripheral forms: Arthritis or enthesitis higher than or equal to 1 site and at least one of the following:. Global assessment of the disease by the patient higher than or equal to 4 (on a scale 0-10). Increase in erythrocyte sedimentation rate (ESR) and/or CRP above the normality parameters established by the laboratory
- Failure to treatment: Failure to at least 2 NSAIDs at maximum recommended dose during at least 3 months (or a shorter time in case of intolerance, toxicity or contraindication).·In cases of ankylosing spondylitis with peripheral joint involvement, salazopyrine should have been used at a dose of 2-3 g per day and/or methotrexate (15 mg/week) for 4 months (or a shorter time in case of intolerance, toxicity or contraindication). In case of oligoarticular or localized involvement in enthesis: lack of response, at the discretion of the investigator, to local infiltrations and/or synoviorthesis.
- Be between 18-70 years of age
- Negative result of a pregnancy test in serum in screening visit and in urine in baseline visit, done in all women, except those surgically sterilized and those who have at least one year of menopause.
Key exclusion criteria (17 listed)
- Contraindications for treatment with anti-TNF
- Complete ankylosis of spine
- Onset of treatment with DMARDs in the 4 weeks prior to baseline (SSZ, MTX and HCQ are permitted if the administrated dose has been maintained stable in the 4 weeks prior to baseline). Furthermore, patients with a dose of prednisone >10 mg/d or equivalent or modified in the 2 weeks prior to the baseline visit, those in whose infiltration has been performed with intraarticular corticosteroids has been performed in the 4 weeks prior to the screening visit and those who follow treatment with more than one NSAID in the 2 weeks prior to the baseline visit are excluded.
- Previous treatment with other TNF inhibitors and other biological drugs
- Abnormalities in hematology profiles defined by:
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 |
|---|---|---|
| etanerceptEtanercept 50 mg twice a week (BIW) for 12 weeks | Drug | 1 |
| etanercept/placeboEtanercept 50 mg once a week (QW) and placebo once a week for 12 weeks | Drug | 2 |
Primary outcome
Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 20.
Time frame: 12 weeks
ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients. ASAS = 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement (vs. baseline) and an absolute change ≥ 10 units on a 0-100 scale (0=no disease activity; 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.
15 secondary outcomes
Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 40.
Time frame: 12 weeks
Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 50.
Time frame: 12 weeks
Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 70.
Time frame: 12 weeks
Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 5/6.
Time frame: 12 weeks
Number of Patients Achieving Partial Remission.
Time frame: 12 weeks
Change in Nocturnal Back and Overall Spinal Pain From Baseline to Week 12.
Time frame: Baseline and 12 weeks
Change in Physician and Patient Global Assessment (PGA) of Pain From Baseline to Week 12.
Time frame: Baseline and 12 weeks
Change in Bath Ankylosing Spondylitis Functional Index (BASFI) From Baseline to Week 12.
Time frame: Baseline and 12 weeks
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) From Baseline to Week 12.
Time frame: Baseline and 12 weeks
Change in Bath Ankylosing Spondylitis Metrology Index (BASMI) From Baseline to Week 12.
Time frame: Baseline and 12 weeks
Change in Erythrocyte Sedimentation Rate (ESR) From Baseline to Week 12.
Time frame: Baseline and 12 weeks
Ankylosing Spondylitis Quality of Life (EuroQoL) Questionnaire
Time frame: 12 weeks
Change in 36-Item Short-Form Health Survey (SF-36) From Baseline to Week 12.
Time frame: Baseline and 12 weeks
Improvement of Ocular Inflammatory Disease in Patients With Baseline Symptoms
Time frame: 12 weeks
Change in C-reactive Protein (CRP) From Baseline to Week 12.
Time frame: Baseline and 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21700683Navarro-Sarabia F, Fernandez-Sueiro JL, Torre-Alonso JC, Gratacos J, Queiro R, Gonzalez C, Loza E, Linares L, Zarco P, Juanola X, Roman-Ivorra J, Martin-Mola E, Sanmarti R, Mulero J, Diaz G, Armendariz Y, Collantes E. High-dose etanercept in ankylosing spondylitis: results of a 12-week randomized, double blind, controlled multicentre study (LOADET study). Rheumatology (Oxford). 2011 Oct;50(10):1828-37. doi: 10.1093/rheumatology/ker083. Epub 2011 Jun 23.
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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.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing etanercept in people with Ankylosing Spondylitis, run by Wyeth is now a wholly owned subsidiary of Pfizer.
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 10 inclusion and 17 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 28 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
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 13 Aug 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?
Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 20. (time frame: 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 NCT00873730, which also lists 1 linked publication.
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 28 Apr 2010.