SchizophreniaPhase 4NCT00303602

Comparing the Effect of Under the Tongue Olanzapine Versus Swallowed Olanzapine on Body Mass Index (A Ratio of Weight to Height)

A Phase 4 study testing Sublingual orally disintegrating olanzapine (SODO) and Oral olanzapine in people with Schizophrenia and Schizoaffective Disorder, run by Eli Lilly and Company at 21 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is testing if under the tongue olanzapine for schizophrenia, related psychosis, schizoaffective disorder or bipolar disorder will have less weight gain than olanzapine that is swallowed, in patients who are already gaining weight on olanzapine. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Schizophrenia, Schizoaffective Disorder, Bipolar Disorder
What is being tested?: Sublingual orally disintegrating olanzapine (SODO) and Oral olanzapine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 149 participants
Where: 21 sitesin 5 countries
Study dates: Mar 2006to Dec 2007
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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Be at least 18 years old
Have gained weight while taking olanzapine
Be able to visit the doctor's office seven times over 4 months (17 weeks)

Who cannot join

Have started a weight loss program within the last 8 weeks
Have an illness that might affect patient's weight during the study
Have an allergy to phenylalanine, mannitol or saccharine
Be taking any medication (except for olanzapine) that might affect patient's weight

Trial locations and contacts

21 sites in 5 countries.

Country

City, postcode or hospital

21 sites in 5 countries

Canada10 sites

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Chatham, Ontario, N7L 1B7
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Dartmouth, Nova Scotia, B2Y 3Z9
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Greater Sudbury, Ontario, P3C 1T4
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Halifax, Nova Scotia, B3H 2E2
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Kingston, Ontario, K7L 4X3
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Penticton, British Columbia, V2A 4M4
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Sherbrooke, Quebec, J1G 1W4
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Sydney, Nova Scotia, B1S 2E8
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Windsor, Ontario, N9C 3Z4
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Winnipeg, Manitoba, R3E 3N4

Other trials in Canada

United States7 sites

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Atlanta, Georgia, 30308
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Escondido, California, 92025
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Garden Grove, California, 92845
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Las Vegas, Nevada, 89102
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
National City, California, 91950
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Orange, California, 92868
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Staten Island, New York, 10312

Other trials in United States

Netherlands2 sites

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Amersfoort, 3816 CP
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Rotterdam, 3015 GD

Other trials in Netherlands

Mexico1 site

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Mexico City, 01030

Other trials in Mexico

Puerto Rico1 site

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
San Juan, 00918

Other trials in Puerto Rico

About this study

Official title: BMI Evaluation: Placebo and Active Comparator Trial of Olanzapine Zydis Pills Used Sublingually (PLATYPUS)

Conditions: Schizophrenia, Schizoaffective Disorder, Bipolar Disorder
Being tested: Sublingual orally disintegrating olanzapine (SODO), Oral olanzapine
Medical subject headings: Schizophrenia, Psychotic Disorders, Bipolar Disorder

What participants receive

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

Sublingual orally disintegrating olanzapine (SODO)Drug
Also called LY170053, Zydis
5 to 20mg dose, supplied in 5mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks.
Oral olanzapineDrug
Also called LY170053, Zyprexa
5 to 20mg dose, supplied in 5mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks.

Study groups in NCT00303602
Study group	Role	What they receive
A	Experimental	Sublingual orally disintegrating olanzapine (SODO) Receives: Drug: Sublingual orally disintegrating olanzapine (SODO)
B	Active comparator	Oral olanzapine Receives: Drug: Oral olanzapine

What is being measured

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

Time Course of Change From Baseline in Body Mass Index (BMI)
Body mass index is an estimate of body fat based on body weight divided by height squared. Comparison of changes at various time points throughout the study. Change = Time point value minus baseline (Visit 2) value.
Measured: Visit 2 (Baseline) to Visit 7 (16 Weeks)

Secondary outcomes (17)

Mean Change From Baseline to 16 Week Endpoint in Body Mass Index (BMI)
Body mass index is an estimate of body fat based on body weight divided by height squared. Comparison of change from baseline to endpoint. Change = Endpoint (Week 16) minus Baseline (Week 0)
Measured: Visit 2 (Baseline) and Visit 7 (Week 16)
Mean Change From Baseline to 16 Week Endpoint in Body Mass Index (BMI) for the Treatment Completers
Body mass index is an estimate of body fat based on body weight divided by height squared. Comparisons of change from baseline to endpoint between participants who completed their treatment. Change = Endpoint value minus Baseline value.
Measured: Visit 2 (Baseline) and Visit 7 (16 Weeks)
Mean Change From Baseline to 16 Week Endpoint in Weight
Weight of undressed patient (undergarments allowed), measured preferably at the same time each day.
Measured: Visit 2 (Baseline) and Visit 7 (16 Weeks)
Mean Change From Baseline to 16 Week Endpoint in Waist Circumference
Waist circumference is measured on a bare abodomen just above the hip bone.
Measured: Visit 2 (Baseline) and Visit 7 (Week 16)
Number of Patients Achieving at Least 5% Loss of Body Weight in Any Post-Baseline Period
Percentage loss of body weight = 100*(postbaseline weight - baseline weight)/baseline weight
Measured: Visit 2 (Baseline) to Visit 7 (Week 16)
Number of Participants Discontinuing the Trial by Visit (Week)
The number of participants who discontinued by visit (non-cumulative).
Measured: Visit 2 (Baseline) to Visit 7 (Week 16)
Change From Baseline to 16 Week Endpoint in Subjective Appetite Using a Visual Analog Scale
Participant chooses where they think their appetite lies on a 10 centimeter line between two anchors (0 - very poor appetite and 10 - very strong appetite). The possible range of scores is 0 to 100 and represents millimeters on the 10 centimeter line.
Measured: Visit 2 (Baseline) and Visit 7 (Week 16)
Mean Change From Baseline to 16 Week Endpoint in Blood Pressure
Sitting blood pressure, taken from the same arm.
Measured: Visit 2 (Baseline) and Visit 7 (Week 16)
Mean Change From Baseline to 16 Week Endpoint in Fasting Lipoproteins (Total Cholesterol, High-Density Lipoprotein Cholesterol [HDL-Cholesterol], Low-Density Lipoprotein Cholesterol [LDL-Cholesterol] [Calculated], and Triglycerides)
Patients should be fasting a minimum of eight hours prior to lipoprotein measurements.
Measured: Visit 2 (Baseline) and Visit 7 (Week 16)
Change From Baseline to 16 Week Endpoint in Fasting Plasma Glucose
Patients should be fasting a minimum of eight hours prior to plasma glucose measurement.
Measured: Visit 2 (Baseline) and Visit 7 (Week 16)
Mean Change From Baseline to 16 Week Endpoint in Fasting Serum Insulin
Patients should be fasting a minimum of eight hours prior to serum insulin measurement.
Measured: Visit 2 (Baseline) and Visit 7 (Week 16)
Mean Change From Baseline to 16 Week Endpoint in Glycosylated Hemoglobin
Measured: Visit 2 (Baseline) and Visit 7 (Week 16)
Mean Changes From Baseline to 16 Week Endpoint Homeostasis Model Assessments of Insulin Sensitivity HOMA-S (Calculated)
HOMA-S is an estimate of insulin sensitivity. The HOMA model is a computer model of the glucose insulin feedback system in the fasted state. The model consists of a number of non-linear empirical equations describing the functions of organs and tissues involved in glucose regulation.
Measured: Visit 2 (Baseline) and Visit 7 (Week 16)
Number of Participants Meeting a Definition for the Presence of Metabolic Syndrome as Defined by Adult Treatment Panel III (ATP III) Criteria at Baseline and 16 Week Endpoint
Patient meets definition of metabolic syndrome if they have >=3 risk factors: Waist circumference (men>102cm, women>88cm); triglycerides >=1.7mmol/L; HDL cholesterol (men<1.04mmol/L, women<1.30mmol/L); blood pressure >135/>=85 mmHg; Fasting glucose >=6.1mmol/L
Measured: Visit 2 (Baseline) and Visit 7 (Week 16)
Mean Change From Baseline to 16 Week Endpoint in the Clinical Global Impression-Severity (CGI-S) Scale
Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Measured: Visit 2 (Baseline) and Visit 7 (Week 16)
Mean Change From Baseline to 16 Week Endpoint in the Subjective Well-Being Under Neuroleptics (SWN) Scale
Measures subjective well-being for previous 7 days. 20 items covering 5 health domains (subscales) (4 items each): emotional regulation, self-control, mental functioning, social integration, and physical functioning. Individual scores range from 1 (not at all) to 6 (very much). Subscale scores range from 1 to 24. Total score ranges from 1 to 120.
Measured: Visit 2 (Baseline) and Visit 7 (Week 16)
Mean Change From Baseline to 16 Week Endpoint in the Global Assessment of Functioning (GAF) Scale
Measures physician's judgment of a patient's overall level of functioning. Ratings are based on a scale of 1 to 100, with the following classification range: 1-10 (severely impaired) to 91-100 (superior functioning).
Measured: Visit 2 (Baseline) and Visit 7 (Week 16)

Timeline

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

Mar 2006Dec 2007

First posted17 Mar 2006 (estimated)
Study startMar 2006
Primary completionDec 2007
Study completionDec 2007

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 SchizophreniaStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 149 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00303602
Sponsor's protocol ID: 10268
Other IDs: F1D-CA-S063
Status last verified: Jun 2009
First submitted: 15 Mar 2006
Last updated: 10 Jun 2009
Results posted: Yes, on ClinicalTrials.gov

Publications

Case M, Treuer T, Karagianis J, Hoffmann VP. The potential role of appetite in predicting weight changes during treatment with olanzapine. BMC Psychiatry. 2010 Sep 14;10:72. doi: 10.1186/1471-244X-10-72.
PubMed 20840778

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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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: BMI Evaluation: Placebo and Active Comparator Trial of Olanzapine Zydis Pills Used Sublingually (PLATYPUS)
ClinicalTrials.gov ID: NCT00303602
Acronym / sponsor ID: 10268
Conditions: Schizophrenia, Schizoaffective Disorder, Bipolar Disorder
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 149 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Mar 2006
Primary completion: Dec 2007 (actual)
Study completion: Dec 2007 (actual)
First posted: 17 Mar 2006 (estimated)
Results: Posted 2 Jun 2009

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
A	Experimental	Drug: Sublingual orally disintegrating olanzapine (SODO)Sublingual orally disintegrating olanzapine (SODO)
B	Active comparator	Drug: Oral olanzapineOral olanzapine

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Be at least 18 years old
Have gained weight while taking olanzapine
Be able to visit the doctor's office seven times over 4 months (17 weeks)

Key exclusion criteria (4 listed)

Have started a weight loss program within the last 8 weeks
Have an illness that might affect patient's weight during the study
Have an allergy to phenylalanine, mannitol or saccharine
Be taking any medication (except for olanzapine) that might affect patient's weight

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
Sublingual orally disintegrating olanzapine (SODO)Also: LY170053, Zydis5 to 20mg dose, supplied in 5mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks.	Drug	A
Oral olanzapineAlso: LY170053, Zyprexa5 to 20mg dose, supplied in 5mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks.	Drug	B

Primary outcome

Time Course of Change From Baseline in Body Mass Index (BMI)
Time frame: Visit 2 (Baseline) to Visit 7 (16 Weeks)
Body mass index is an estimate of body fat based on body weight divided by height squared. Comparison of changes at various time points throughout the study. Change = Time point value minus baseline (Visit 2) value.

17 secondary outcomes

Mean Change From Baseline to 16 Week Endpoint in Body Mass Index (BMI)
Time frame: Visit 2 (Baseline) and Visit 7 (Week 16)
Mean Change From Baseline to 16 Week Endpoint in Body Mass Index (BMI) for the Treatment Completers
Time frame: Visit 2 (Baseline) and Visit 7 (16 Weeks)
Mean Change From Baseline to 16 Week Endpoint in Weight
Time frame: Visit 2 (Baseline) and Visit 7 (16 Weeks)
Mean Change From Baseline to 16 Week Endpoint in Waist Circumference
Time frame: Visit 2 (Baseline) and Visit 7 (Week 16)
Number of Patients Achieving at Least 5% Loss of Body Weight in Any Post-Baseline Period
Time frame: Visit 2 (Baseline) to Visit 7 (Week 16)
Number of Participants Discontinuing the Trial by Visit (Week)
Time frame: Visit 2 (Baseline) to Visit 7 (Week 16)
Change From Baseline to 16 Week Endpoint in Subjective Appetite Using a Visual Analog Scale
Time frame: Visit 2 (Baseline) and Visit 7 (Week 16)
Mean Change From Baseline to 16 Week Endpoint in Blood Pressure
Time frame: Visit 2 (Baseline) and Visit 7 (Week 16)
Mean Change From Baseline to 16 Week Endpoint in Fasting Lipoproteins (Total Cholesterol, High-Density Lipoprotein Cholesterol [HDL-Cholesterol], Low-Density Lipoprotein Cholesterol [LDL-Cholesterol] [Calculated], and Triglycerides)
Time frame: Visit 2 (Baseline) and Visit 7 (Week 16)
Change From Baseline to 16 Week Endpoint in Fasting Plasma Glucose
Time frame: Visit 2 (Baseline) and Visit 7 (Week 16)
Mean Change From Baseline to 16 Week Endpoint in Fasting Serum Insulin
Time frame: Visit 2 (Baseline) and Visit 7 (Week 16)
Mean Change From Baseline to 16 Week Endpoint in Glycosylated Hemoglobin
Time frame: Visit 2 (Baseline) and Visit 7 (Week 16)
Mean Changes From Baseline to 16 Week Endpoint Homeostasis Model Assessments of Insulin Sensitivity HOMA-S (Calculated)
Time frame: Visit 2 (Baseline) and Visit 7 (Week 16)
Number of Participants Meeting a Definition for the Presence of Metabolic Syndrome as Defined by Adult Treatment Panel III (ATP III) Criteria at Baseline and 16 Week Endpoint
Time frame: Visit 2 (Baseline) and Visit 7 (Week 16)
Mean Change From Baseline to 16 Week Endpoint in the Clinical Global Impression-Severity (CGI-S) Scale
Time frame: Visit 2 (Baseline) and Visit 7 (Week 16)
Mean Change From Baseline to 16 Week Endpoint in the Subjective Well-Being Under Neuroleptics (SWN) Scale
Time frame: Visit 2 (Baseline) and Visit 7 (Week 16)
Mean Change From Baseline to 16 Week Endpoint in the Global Assessment of Functioning (GAF) Scale
Time frame: Visit 2 (Baseline) and Visit 7 (Week 16)

Results and safety

Results posted to the registry on 2 Jun 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SODO	84	65
SOT	65	50

Primary outcome: Time Course of Change From Baseline in Body Mass Index (BMI)

Time frame: Visit 2 (Baseline) to Visit 7 (16 Weeks). Least squares mean (Standard Error). Unit: kilograms/square meters

Measure	SODO n = 82	SOT n = 63
Week 2 (N=82, N=63)	0.09 (0.06)	0.16 (0.07)
Week 4 (N=79, N=63)	0.25 (0.08)	0.27 (0.09)
Week 8 (N=75, N=58)	0.34 (0.12)	0.32 (0.13)
Week 12 (N=70, N=54)	0.47 (0.16)	0.54 (0.18)
Week 16 (N=67, N=51)	0.52 (0.18)	0.72 (0.20)

SODO vs SOT: p = 0.428, Mixed Models Analysis
SODO vs SOT: p = 0.859, Mixed Models Analysis
SODO vs SOT: p = 0.885, Mixed Models Analysis

Population analysed: Intention to treat

17 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
SODO	2 of ?	32 of ?	Not reported
SOT	0 of ?	32 of ?	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2009.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 20840778Case M, Treuer T, Karagianis J, Hoffmann VP. The potential role of appetite in predicting weight changes during treatment with olanzapine. BMC Psychiatry. 2010 Sep 14;10:72. doi: 10.1186/1471-244X-10-72.
Lilly Clinical Trial RegistryLink 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.

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

Eli Lilly and Company

21 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 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 10 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Canada, United States, Netherlands, Mexico, Puerto Rico. 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 2 Jun 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time Course of Change From Baseline in Body Mass Index (BMI) (time frame: Visit 2 (Baseline) to Visit 7 (16 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 NCT00303602, 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 10 Jun 2009.