ObesityPhase 4LOSSNCT00115063
LOSS- Louisiana Obese Subjects Study
A Phase 4 study testing group sessions, sibutramine, orlistat, diethylpropion and Low Calorie Diet, Health One in people with Obesity, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
LOSS is a pragmatic clinical evaluation of intensive medical approaches to weight loss for individuals with extreme obesity (body mass index [BMI] 40-60 kg/m2). The intensive medical treatment is designed to produce 25% weight loss from baseline and to maintain at least 20% weight loss from baseline. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Obesity
- What is being tested?
- group sessions, sibutramine, orlistat, diethylpropion and Low Calorie Diet, Health One
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Jan 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participant in the Exclusive Provider Organization (EPO), Managed Care Organization (MCO) and Preferred Provider Organization (PPO) programs of the Louisiana State Employees Group Benefits Health Insurance
- Agree to travel for treatment to the assigned study site
- Agree to randomized treatment assignment
- Male and females age 20-60 years
- Body Mass Index >40kg/m2 but < 60 kg/m2
- Females must be non-pregnant and using an approved contraception method
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- Complete Blood Count (CBC): normal hematocrit, white count and platelet count, unless waived by Principal Investigator (PI)
- Uric Acid <9.0 mg/dl
- Normal Creatinine
- Normal Thyroid Stimulating Hormone (TSH)
- Negative urine pregnancy test for women of childbearing potential
- Able to give written informed consent
- Able to comply with study procedures
Who cannot join
- Factors that may limit adherence to interventions or affect conduct of the trial:
- Unable or unwilling to give informed consent or communicate with local study staff
- Hospitalization for psychiatric illness or substance use/abuse within the past year
- Self-report of alcohol or substance abuse within the past twelve months
- Current major depressive episode or history of suicidal behaviors
- Endorsement of significant recent suicidal ideation (as determined by PI)
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- Travel plans that do not permit participation
- History of prior bariatric surgery, small bowel resection, or extensive bowel resection
- Current use of chronic systemic corticosteroids, appetite suppressants, antipsychotic medication, herbal medications for weight loss or any medication not approved by the PI.
- Another member of the household is a participant or staff member in the study
- History of eating disorder such as anorexia nervosa, bulimia, or binge eating
- Diagnosis of schizophrenia, other psychotic disorders, bipolar disorder, or personality disorder (as determined by the PI)
- Currently pregnant or nursing or plans to become pregnant in the next five years
- Except for non-melanoma skin cancer, cancer requiring treatment in the past five years, unless the prognosis is excellent
- Self report of Human Immunodeficiency Virus (HIV) positive, hepatitis C or active tuberculosis
- Cardiovascular disease event within the past year
- Severe congestive heart failure (New York Heart Association [NYHA] Functional Class III, IV)
- Second degree or greater heart block
- Blood Pressure >160 systolic or >100 diastolic on two consecutive visits, unless treated and re-screened
- Based upon responses to psychological screening or an interview, patients may be excluded by the study psychologist.
- Other medical, psychiatric, or behavioral limitations that in the judgment of the investigator may interfere with study participation or the ability to follow the intervention protocol.
- Pregnancy is to be avoided during the study. Women who have not had a hysterectomy or oophorectomy must have a negative urine pregnancy test result at screening. Women of childbearing potential will be allowed to participate if they have undergone tubal ligation, or use one of the following types of contraception: properly used condom or diaphragm, oral contraceptives, hormonal implant, or intrauterine device (IUD). Sexual abstinence may constitute an acceptable birth control method for this study with investigator approval. Women with male partners who have had a successful vasectomy (more than one year of unprotected sexual intercourse without pregnancy) are not required to use additional birth control methods as long as the relationship remains exclusive, and the woman agrees to use an approved contraception method with any other male partner. Questions regarding individual patient contraceptive practices should be directed to the Principal Investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Management of Clinical Trials
Baton Rouge, Louisiana, 70808
About this study
Official title: Loss - Louisiana Obese Subjects Study
LOSS is a pragmatic clinical evaluation of intensive medical approaches to weight loss for individuals with extreme obesity (body mass index [BMI] 40-60 kg/m2). The intensive medical treatment is designed to produce 25% weight loss from baseline and to maintain at least 20% weight loss from baseline. The intensive medical treatment is compared to a usual care treatment model where individuals utilize self directed approaches to weight loss. The active treatment period is three years, followed by two years of observation.
Read the detailed description
LOSS is a pragmatic clinical trial designed to evaluate intensive medical treatment for patients with severe obesity who would otherwise qualify as candidates for obesity surgery and who are covered by the Louisiana Office of Group Benefits (OGB) Health Insurance. LOSS will track the efficacy, safety and costs to compare two patient management approaches - intensive medical treatment, or a usual medical care treatment model. Recruitment will be done by mailers to insured patients to identify eligible candidates. We will randomly assign eligible volunteers to intensive medical treatment (n=240) or usual care (n=240). Patients will be evaluated annually and medical treatments are given in eight clinics around Louisiana. The eight sites are in Alexandria, Baton Rouge, Lafayette, Lake Charles, Monroe, Hammond, New Orleans and Shreveport.
Hypothesis:
We hypothesize that we can achieve weight loss after two and five years that exceeds 20% from baseline with intensive medical management of persons with class III obesity and that this weight loss is greater than that achieved with usual medical care including access to a weight management web site.
Our secondary hypotheses are: 1) that the weight loss at year 2 and 5 in the intensive medical group is associated with improvements in blood pressure, fasting glucose, lipids, health-related quality of life and psychosocial measures and is greater improvement than that achieved with usual medical care and access to a website; and 2) that total medical costs in the intensive medical management group will compare favorably to total medical costs in the usual care group (i.e., total reimbursement from insurance costs will be less, even when the expense of the treatment is considered).
Overall Aim:
The overarching aim of this study is to observe the effect of an intensive medical management program versus usual care for class III obesity on weight loss, total medical costs and, on measures of health risks associated with weight loss (blood pressure, blood glucose, blood lipids, and health-related quality of life).
Specific Aims:
Primary: The primary specific aim of the LOSS study is to test the hypothesis that the weight loss efficacy at years 2 and 5 for an intensive medical treatment program for Class III obesity produces greater weight loss, as compared to a condition of usual care.
Secondary: The secondary aims of the study are:
- To evaluate the percent change in body weight, absolute change in body weight (kilograms) and percent excess weight lost from baseline at months 3, 6, 12, 24, 36, 48 and 60 for medically treated patient groups, and at years 1, 2, 3, 4 and 5 for both groups.
- To evaluate the number and proportion of subjects who maintain 100% and 80% of 12 months weight lost at months 24, 36, 48 and 60 for medically treated patients and at years 2, 3, 4 and 5 for both groups.
- To evaluate the changes from baseline in blood pressure, pulse rate, and efficacy laboratory parameters at visits on months 3, 6, 12, 24, 36, 48 and 60 for the medically treated patient group, and at years 1, 2, 3, 4 and 5 for both groups.
- To assess the safety and tolerability of the intervention regimens at months 3, 6, 12, 24, 36, 48 and 60 for the medically treated patient group.
- To assess the total medical costs of the participants treated with intensive medical treatment and for the patients receiving usual care at years 1, 2, 3, 4 and 5.
- To assess additional psychosocial and economic measures (health-related quality of life, pain, depression, and stress) for the intervention group at months 4, 8, 12, 24, 36, 48 and 60 months for both groups at years 1, 2, 3, 4, and 5.
- To compare subgroups of patients with class III obesity to determine if differences in outcome exist for gender, race, education level, decades of age and presence of co-morbid conditions.
The Pennington Biomedical Research Center is the lead institution for the project. Pennington Management of Clinical Trials (PMCT) will serve as the Coordinating Center to manage enrollment and data acquisition and will report all data of health and cost results to a Data Safety Monitoring Board on a regular basis. Major data reports and scientific publications occur at years 2 and 5.
- Conditions
- Obesity
- Being tested
- group sessions, sibutramine, orlistat, diethylpropion, Low Calorie Diet, Health One, Intensive Medical Combination Therapy for Obesity, Control Condition
- Keywords
- obesity, Low Calorie Diet, Obesity Pharmacotherapy, Pragmatic Clinical Trial
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
group sessionsBehavioural
group sessions lead by a trained primary care clinic employee
sibutramine, orlistat, diethylpropionDrug
dosage modified according to package insert instructions at discretion of primary care physicians
Low Calorie Diet, Health OneBehavioural
liquid diet for 8-12 weeks to induce weight loss
Intensive Medical Combination Therapy for ObesityOther
Very Low Calorie Liquid diet, Group Behavioral Therapy, Meal Replacement Therapy, Obesity Pharmacotherapy and a "Treatment Toolbox".
Control ConditionOther
Access to the Mayo Clinic weight management website and usual care from the primary care physician
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Intensive Medical Intervention including Low Calorie Liquid Diet, Weight loss medications, Group Behavioral Therapy and a "Tool Box" approach Receives: Behavioral: group sessions; Drug: sibutramine, orlistat, diethylpropion; Behavioral: Low Calorie Diet, Health One; Other: Intensive Medical Combination Therapy for Obesity |
| 2 | Active comparator | Access to Weight Loss Informational Website sponsored by the Mayo Clinic Receives: Other: Control Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline Weight
Measured: Baseline, 2 years
Secondary outcomes (5)
Change in Weight From Baseline in Kilograms (kg)
Measured: Baseline, 2 years
Change in Blood Pressure
Measured: Baseline, 2 years
Percent Change in Blood Tests- Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), Triglycerides and Uric Acid
Measured: Baseline, 2 years
Change in Fasting Plasma Glucose (FPG) in Milligrams Per Deciliter (mg/dL)
Measured: Baseline, 2 years
Change in Duke Activity Status Index (DASI) Questionnaire Score
The DASI was used to access changes in fuctional capacity during the study. The highest score possible is 58.2 and the lowest is 0. The score for each individual question varied depending on the intensity of the activity being evaluated. The higher the score, the more physically active a person is to this set of activities of daily living questions.
Measured: Baseline, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2005 (estimated)
- Study startJul 2005
- Primary completionDec 2007
- Study completionJan 2008
Why it stopped: ethical issues of continuing control group without treatment
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 ObesityStudies 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
- None (open label)
- Enrolment
- 390 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Louisiana Office of Group Benefits
- Responsible party
- Principal investigator, Donna H. Ryan, MD, Pennington Biomedical Research Center
- Investigators
- Donna H Ryan, MD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00115063
- Sponsor's protocol ID
- PBRC 25002
- Acronym
- LOSS
- Status last verified
- Jan 2016
- First submitted
- 20 Jun 2005
- Last updated
- 22 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Johnson WD, Brashear MM, Gupta AK, Rood JC, Ryan DH. Incremental weight loss improves cardiometabolic risk in extremely obese adults. Am J Med. 2011 Oct;124(10):931-8. doi: 10.1016/j.amjmed.2011.04.033.
PubMed 21962313Ryan DH, Johnson WD, Myers VH, Prather TL, McGlone MM, Rood J, Brantley PJ, Bray GA, Gupta AK, Broussard AP, Barootes BG, Elkins BL, Gaudin DE, Savory RL, Brock RD, Datz G, Pothakamuri SR, McKnight GT, Stenlof K, Sjostrom LV. Nonsurgical weight loss for extreme obesity in primary care settings: results of the Louisiana Obese Subjects Study. Arch Intern Med. 2010 Jan 25;170(2):146-54. doi: 10.1001/archinternmed.2009.508.
PubMed 20101009
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Loss - Louisiana Obese Subjects Study
- ClinicalTrials.gov ID
- NCT00115063
- Acronym / sponsor ID
- LOSS / PBRC 25002
- Conditions
- Obesity
- Keywords
- obesity, Low Calorie Diet, Obesity Pharmacotherapy, Pragmatic Clinical Trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: ethical issues of continuing control group without treatment
- Enrolment
- 390 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- Louisiana Office of Group Benefits
- Study start
- Jul 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 21 Jun 2005 (estimated)
- Results
- Posted 7 Jun 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
LOSS is a pragmatic clinical evaluation of intensive medical approaches to weight loss for individuals with extreme obesity (body mass index [BMI] 40-60 kg/m2). The intensive medical treatment is designed to produce 25% weight loss from baseline and to maintain at least 20% weight loss from baseline. The intensive medical treatment is compared to a usual care treatment model where individuals utilize self directed approaches to weight loss. The active treatment period is three years, followed by two years of observation.
Detailed description
LOSS is a pragmatic clinical trial designed to evaluate intensive medical treatment for patients with severe obesity who would otherwise qualify as candidates for obesity surgery and who are covered by the Louisiana Office of Group Benefits (OGB) Health Insurance. LOSS will track the efficacy, safety and costs to compare two patient management approaches - intensive medical treatment, or a usual medical care treatment model. Recruitment will be done by mailers to insured patients to identify eligible candidates. We will randomly assign eligible volunteers to intensive medical treatment (n=240) or usual care (n=240). Patients will be evaluated annually and medical treatments are given in eight clinics around Louisiana. The eight sites are in Alexandria, Baton Rouge, Lafayette, Lake Charles, Monroe, Hammond, New Orleans and Shreveport.
Hypothesis:
We hypothesize that we can achieve weight loss after two and five years that exceeds 20% from baseline with intensive medical management of persons with class III obesity and that this weight loss is greater than that achieved with usual medical care including access to a weight management web site.
Our secondary hypotheses are: 1) that the weight loss at year 2 and 5 in the intensive medical group is associated with improvements in blood pressure, fasting glucose, lipids, health-related quality of life and psychosocial measures and is greater improvement than that achieved with usual medical care and access to a website; and 2) that total medical costs in the intensive medical management group will compare favorably to total medical costs in the usual care group (i.e., total reimbursement from insurance costs will be less, even when the expense of the treatment is considered).
Overall Aim:
The overarching aim of this study is to observe the effect of an intensive medical management program versus usual care for class III obesity on weight loss, total medical costs and, on measures of health risks associated with weight loss (blood pressure, blood glucose, blood lipids, and health-related quality of life).
Specific Aims:
Primary: The primary specific aim of the LOSS study is to test the hypothesis that the weight loss efficacy at years 2 and 5 for an intensive medical treatment program for Class III obesity produces greater weight loss, as compared to a condition of usual care.
Secondary: The secondary aims of the study are:
- To evaluate the percent change in body weight, absolute change in body weight (kilograms) and percent excess weight lost from baseline at months 3, 6, 12, 24, 36, 48 and 60 for medically treated patient groups, and at years 1, 2, 3, 4 and 5 for both groups.
- To evaluate the number and proportion of subjects who maintain 100% and 80% of 12 months weight lost at months 24, 36, 48 and 60 for medically treated patients and at years 2, 3, 4 and 5 for both groups.
- To evaluate the changes from baseline in blood pressure, pulse rate, and efficacy laboratory parameters at visits on months 3, 6, 12, 24, 36, 48 and 60 for the medically treated patient group, and at years 1, 2, 3, 4 and 5 for both groups.
- To assess the safety and tolerability of the intervention regimens at months 3, 6, 12, 24, 36, 48 and 60 for the medically treated patient group.
- To assess the total medical costs of the participants treated with intensive medical treatment and for the patients receiving usual care at years 1, 2, 3, 4 and 5.
- To assess additional psychosocial and economic measures (health-related quality of life, pain, depression, and stress) for the intervention group at months 4, 8, 12, 24, 36, 48 and 60 months for both groups at years 1, 2, 3, 4, and 5.
- To compare subgroups of patients with class III obesity to determine if differences in outcome exist for gender, race, education level, decades of age and presence of co-morbid conditions.
The Pennington Biomedical Research Center is the lead institution for the project. Pennington Management of Clinical Trials (PMCT) will serve as the Coordinating Center to manage enrollment and data acquisition and will report all data of health and cost results to a Data Safety Monitoring Board on a regular basis. Major data reports and scientific publications occur at years 2 and 5.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: group sessions, Drug: sibutramine, orlistat, diethylpropion, Behavioral: Low Calorie Diet, Health One, Other: Intensive Medical Combination Therapy for ObesityIntensive Medical Intervention including Low Calorie Liquid Diet, Weight loss medications, Group Behavioral Therapy and a "Tool Box" approach |
| 2 | Active comparator | Other: Control ConditionAccess to Weight Loss Informational Website sponsored by the Mayo Clinic |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Participant in the Exclusive Provider Organization (EPO), Managed Care Organization (MCO) and Preferred Provider Organization (PPO) programs of the Louisiana State Employees Group Benefits Health Insurance
- Agree to travel for treatment to the assigned study site
- Agree to randomized treatment assignment
- Male and females age 20-60 years
- Body Mass Index >40kg/m2 but < 60 kg/m2
Key exclusion criteria (22 listed)
- Unable or unwilling to give informed consent or communicate with local study staff
- Hospitalization for psychiatric illness or substance use/abuse within the past year
- Self-report of alcohol or substance abuse within the past twelve months
- Current major depressive episode or history of suicidal behaviors
- Endorsement of significant recent suicidal ideation (as determined by PI)
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 |
|---|---|---|
| group sessionsgroup sessions lead by a trained primary care clinic employee | Behavioural | 1 |
| sibutramine, orlistat, diethylpropiondosage modified according to package insert instructions at discretion of primary care physicians | Drug | 1 |
| Low Calorie Diet, Health Oneliquid diet for 8-12 weeks to induce weight loss | Behavioural | 1 |
| Intensive Medical Combination Therapy for ObesityVery Low Calorie Liquid diet, Group Behavioral Therapy, Meal Replacement Therapy, Obesity Pharmacotherapy and a "Treatment Toolbox". | Other | 1 |
| Control ConditionAccess to the Mayo Clinic weight management website and usual care from the primary care physician | Other | 2 |
Primary outcome
Percent Change From Baseline Weight
Time frame: Baseline, 2 years
5 secondary outcomes
Change in Weight From Baseline in Kilograms (kg)
Time frame: Baseline, 2 years
Change in Blood Pressure
Time frame: Baseline, 2 years
Percent Change in Blood Tests- Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), Triglycerides and Uric Acid
Time frame: Baseline, 2 years
Change in Fasting Plasma Glucose (FPG) in Milligrams Per Deciliter (mg/dL)
Time frame: Baseline, 2 years
Change in Duke Activity Status Index (DASI) Questionnaire Score
Time frame: Baseline, 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21962313Johnson WD, Brashear MM, Gupta AK, Rood JC, Ryan DH. Incremental weight loss improves cardiometabolic risk in extremely obese adults. Am J Med. 2011 Oct;124(10):931-8. doi: 10.1016/j.amjmed.2011.04.033.
- Derived from this study: PubMed 20101009Ryan DH, Johnson WD, Myers VH, Prather TL, McGlone MM, Rood J, Brantley PJ, Bray GA, Gupta AK, Broussard AP, Barootes BG, Elkins BL, Gaudin DE, Savory RL, Brock RD, Datz G, Pothakamuri SR, McKnight GT, Stenlof K, Sjostrom LV. Nonsurgical weight loss for extreme obesity in primary care settings: results of the Louisiana Obese Subjects Study. Arch Intern Med. 2010 Jan 25;170(2):146-54. doi: 10.1001/archinternmed.2009.508.
- Pennington Biomedical Research Center home pageLink provided by the sponsor.
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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.
Donna H Ryan, MD principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing group sessions, sibutramine, orlistat, diethylpropion and Low Calorie Diet, Health One in people with Obesity, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 22 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 22 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 7 Jun 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?
Percent Change From Baseline Weight (time frame: Baseline, 2 years). 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 NCT00115063, 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 22 Feb 2016.