AsthmaPhase 2NCT00507130

A Study to Evaluate the Safety and Tolerability of the Administration of MEDI-528 When Administered in Multiple Doses to Adults With Mild Persistent Asthma

A Phase 2 study testing MEDI528 0.3 mg/kg, MEDI528 1 mg/kg and MEDI528 3 mg/kg in people with Asthma, run by MedImmune LLC at 9 sites in 2 countries.

Completed

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

Official record

Search all trials

Trial summary

The primary objective of this study is to evaluate the safety and tolerability of escalating multiple SC doses of MEDI-528 in adult patients with mild persistent asthma. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Asthma
What is being tested?: MEDI528 0.3 mg/kg, MEDI528 1 mg/kg and MEDI528 3 mg/kg
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 36 participants
Where: 9 sitesin 2 countries
Study dates: Jul 2007to Sep 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female adults, age 18 through 65 years of age at time of screening;
Weight ≤ 100 kg and body mass index ≤ 35;
Written informed consent obtained from the patient prior to receipt of any study medication or beginning study procedures;
Previously documented diagnosis of asthma based on episodic symptoms of airflow obstruction such as wheezing or chest tightness, with alternative diagnoses (e.g., chronic obstructive pulmonary disease) ruled out;
Currently receiving treatment with short-acting β2 agonists, ICS at doses ≤ 264 μg/day fluticasone or equivalent, or both (National Heart, Lung, and Blood Institute [NHLBI], 2002);
FEV1 or peak expiratory flow (PEF) ≥ 80% of predictable value;

Show all 12Show fewer

Have had a diagnosis of mild persistent asthma, defined as having asthma symptoms with a frequency of more than twice a week but less than once daily, or nighttime symptoms with a frequency of more than twice a month but less than once a week (NHLBI, 2002);
Have AHR based on documented clinical history of either methacholine inhalation challenge with PC20 ≤ 16 mg/mL or partial reversibility of ≤ 12% in FEV1 within the past 18 months (including screening);
Able to provide spirometry readings that meet American Thoracic Society/European Respiratory Society standards (Miller, 2005);
Sexually active females, unless surgically sterile or at least 1 year post-menopausal, must use an effective method of avoiding pregnancy (including oral, implanted, or transdermal contraceptives, intrauterine device, female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner) for 21 days prior to the first dose of study drug, and must agree to continue using such precautions through Study Day 150. Cessation of birth control after this point should be discussed with a responsible physician. Sexually active males, unless surgically sterile, must likewise use an effective method of birth control (condom) and must agree to continue using such precautions through Study Day 150;
Ability to complete the study period, including follow-up period, of up to 150 days; and
Willing to forego other forms of experimental treatment and study procedures during the study.

Who cannot join

Receipt of MEDI-528 in any previous clinical study or prior randomization into the trial;
History of allergy or reaction to any component of the MEDI-528 formulation;
Lung disease other than persistent asthma (e.g. chronic bronchitis);
FEV1 < 80% of predicted values;
History of severe asthma or asthma exacerbation requiring intubation;
Use of systemic immunosuppressive drugs including systemic corticosteroids or ICS with doses > 264 μg/day fluticasone or equivalent within 4 weeks prior to Study Day 0;

Show all 26Show fewer

Use of long-acting β2 agonists, theophylline, cromolyn sodium, nedocromil sodium, leukotriene receptor antagonists, or any other inhaled or systemic medication for asthma (except short-acting β2 agonists or ICS at doses ≤ 264 μg/day fluticasone or equivalent) within the 2 weeks prior to Study Day 0;
Current use of any β-adrenergic antagonist (e.g., propranolol);
Any disease or illness, other than asthma, that may require the use of systemic corticosteroids during the study period;
Acute illnesses or evidence of significant active infection, such as fever ≥ 38.0°C (100.5°F) at screening and up through time of the first dose of study drug;
Current allergy vaccination therapy (desensitization immunotherapy), with less than 3 months of stable maintenance doses prior to screening;
Receipt of any investigational drug therapy within 30 days or any biologic(s) within 5 half-lives of the agent prior to the first dose of study drug through Study Day 150;
Receipt of any therapy with a leukocyte-depleting agent unless recovery in white cell count has been documented before screening;
Pregnancy (sexually active females must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to study drug administration on Study Day 0);
Lactating or breastfeeding woman;
Evidence of infection with hepatitis B or C virus, or human immunodeficiency virus-1 or -2 (HIV-1 or HIV-2), or active infection with hepatitis A;
History of significant systemic disease (e.g., cancer, infection, hematological, renal, hepatic, coronary artery disease or other cardiovascular disease, endocrinologic, neurologic, rheumatologic, or gastrointestinal disease);
History of cancer other than non-melanoma skin cancer or cervical carcinoma-in-situ treated with apparent success with curative therapy (remission for ≥ 1 year prior to screening);
History of primary immunodeficiency;
History of pancreatitis;
History of use of tobacco products of more than one cigarette per month or equivalent within 1 year prior to randomization or history of smoking of ≥ 10 pack-years;
Elective surgery planned during the study period through Study Day 150;
Clinically significant abnormalities on physical examination (other than asthma) prior to the first dose of study drug (including but not limited to splenomegaly); Clinically significant abnormality, as determined by the investigator, on 12-lead ECG, MRI, or chest radiograph at the time of screening;
At the time of screening, any abnormality of the following measurements: hemoglobin, total white blood cell count (WBC), platelet count, aspartate transaminase (AST), alanine transaminase (ALT), amylase, or serum creatinine above the upper limits of normal (ULN); or other abnormal laboratory values in the screening panel that, in the opinion of the principal investigator, are judged to be clinically significant;
Evidence of any systemic disease or respiratory disease (other than asthma), any finding upon physical examination or history of any disease that, in the opinion of the investigator or medical monitor, may compromise the safety of the patient in the study or confound the analysis of the study; or
Employees of the clinical study site or any other individuals involved with the conduct of the study, or family members of such individuals.

Trial locations and contacts

9 sites in 2 countries.

Country

City, postcode or hospital

9 sites in 2 countries

United States6 sites

Colorado Allergy & Asthma Centers, PC
Denver, Colorado, 80230
Clinical Research Institute, Inc.
Minneapolis, Minnesota, 55402
Northeast Medical Research Associates, Inc.
North Dartmouth, Massachusetts, 02747
North Carolina Clinical Research
Raleigh, North Carolina, 27607
Spartanburg Medical Research
Spartanburg, South Carolina, 29303
Toledo Center for Clinical Research
Sylvania, Ohio, 43560

Other trials in United States

Canada3 sites

McMaster University
Hamilton, Ontario, L8N 3Z5
Hôpital du Sacré-Coeur de Montréal
Montreal, Quebec, H4J 1C5
Hopital Laval
Québec, Quebec, G1V 4G5

Other trials in Canada

About this study

Official title: A Phase 2A, Randomized, Double-Blind, Placebo-Controlled,Dose-Escalation Study to Evaluate the Safety and Tolerability of Multiple-Dose Subcutaneous Administration of MEDI-528, A Humanized Anti-Interleukin-9 Monoclonal Antibody,When Administered to Adults With Mild Persistent Asthma

The primary objective of this study is to evaluate the safety and tolerability of escalating multiple SC doses of MEDI-528 in adult patients with mild persistent asthma.

Read the detailed description

The secondary objectives of this study are to:

Assess the PK of MEDI-528; and
Assess the IM of MEDI-528 in this patient population.

Conditions: Asthma
Being tested: MEDI528 0.3 mg/kg, MEDI528 1 mg/kg, MEDI528 3 mg/kg, PLACEBO
Medical subject headings: Asthma

What participants receive

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

MEDI528 0.3 mg/kgBiological
MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a subcutaneous (SC) dose for 4 weeks
MEDI528 1 mg/kgBiological
MEDI-528 at a dose of 1 mg/kg administered twice weekly as a subcutaneous (SC) dose for 4 weeks
MEDI528 3 mg/kgBiological
MEDI-528 at a dose of 3 mg/kg administered twice weekly as a subcutaneous (SC) dose for 4 weeks
PLACEBOOther
Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks

Study groups in NCT00507130
Study group	Role	What they receive
MEDI528 0.3 mg/kg	Experimental	MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a subcutaneous (SC) dose for 4 weeks Receives: Biological: MEDI528 0.3 mg/kg
MEDI528 1 mg/kg	Experimental	MEDI-528 at a dose of 1 mg/kg administered twice weekly as a subcutaneous (SC) dose for 4 weeks Receives: Biological: MEDI528 1 mg/kg
MEDI528 3 mg/kg	Experimental	MEDI-528 at a dose of 3 mg/kg administered twice weekly as a subcutaneous (SC) dose for 4 weeks Receives: Biological: MEDI528 3 mg/kg
PLACEBO	Placebo comparator	Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks Receives: Other: PLACEBO

What is being measured

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

Incidence of Adverse Events
Number of participants experiencing adverse events (includes both adverse events and serious adverse events)
Measured: Days 0 - 150
Incidence of Abnormal Troponin Levels
Number of participants with troponin levels greater than upper limit of normal
Measured: Days 0, 14, 28, 56, 84, and 150
Incidence of Abnormal Clinically Significant Electrocardiogram (ECG) Results
Number of participants with abnormal clinically significant ECG results
Measured: Days -14 to -1, 14, 28, 56, 84, and 150
Incidence of Abnormal Clinically Significant Magnetic Resonance Imaging (MRI) Results
Number of participants experiencing abnormal clinically significant MRI results
Measured: Days -14 to -1 and 28
Incidence of Serious Adverse Events
Number of participants experiencing serious adverse events
Measured: Days 0 - 150

Secondary outcomes (4)

Incidence of Anti-drug Antibodies (ADA) to MEDI-528
Number of participants with ADA to MEDI-528
Measured: Days 0, 28, 56, 84, 119, and 150
Time to Observed Maximum Serum Concentration (Tmax)
Tmax of MEDI-528
Measured: Days 0, 3, 7, 10, 14, 17, 21, 24, 26, 28, 31, 35, 42, 49, 56, 70, 84, 119, and 150
Observed Maximum Serum Concentration (Cmax)
Cmax of MEDI-528
Measured: Days 0, 3, 7, 10, 14, 17, 21, 24, 26, 28, 31, 35, 42, 49, 56, 70, 84, 119, and 150
Terminal Phase Half-life (T1/2)
T1/2 of MEDI-528
Measured: Days 0, 3, 7, 10, 14, 17, 21, 24, 26, 28, 31, 35, 42, 49, 56, 70, 84, 119, and 150

Timeline

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

Jul 2007Sep 2008

First posted25 Jul 2007 (estimated)
Study startJul 2007
Primary completionJul 2008
Study completionSep 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 AsthmaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

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

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00507130
Sponsor's protocol ID: MI-CP131
Other IDs: NCT00507130
Status last verified: Oct 2013
First submitted: 23 Jul 2007
Last updated: 11 Dec 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Parker JM, Oh CK, LaForce C, Miller SD, Pearlman DS, Le C, Robbie GJ, White WI, White B, Molfino NA; MEDI-528 Clinical Trials Group. Safety profile and clinical activity of multiple subcutaneous doses of MEDI-528, a humanized anti-interleukin-9 monoclonal antibody, in two randomized phase 2a studies in subjects with asthma. BMC Pulm Med. 2011 Feb 28;11:14. doi: 10.1186/1471-2466-11-14.
PubMed 21356110

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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Study at a glance

From the registry record, last updated by the sponsor on 11 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2A, Randomized, Double-Blind, Placebo-Controlled,Dose-Escalation Study to Evaluate the Safety and Tolerability of Multiple-Dose Subcutaneous Administration of MEDI-528, A Humanized Anti-Interleukin-9 Monoclonal Antibody,When Administered to Adults With Mild Persistent Asthma
ClinicalTrials.gov ID: NCT00507130
Acronym / sponsor ID: MI-CP131
Conditions: Asthma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: MedImmune LLCIndustry (pharma, biotech, devices)
Study start: Jul 2007
Primary completion: Jul 2008 (actual)
Study completion: Sep 2008 (actual)
First posted: 25 Jul 2007 (estimated)
Results: Posted 11 Dec 2013

Clinical summary

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

The primary objective of this study is to evaluate the safety and tolerability of escalating multiple SC doses of MEDI-528 in adult patients with mild persistent asthma.

Detailed description

The secondary objectives of this study are to:

Assess the PK of MEDI-528; and
Assess the IM of MEDI-528 in this patient population.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
MEDI528 0.3 mg/kg	Experimental	Biological: MEDI528 0.3 mg/kgMEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a subcutaneous (SC) dose for 4 weeks
MEDI528 1 mg/kg	Experimental	Biological: MEDI528 1 mg/kgMEDI-528 at a dose of 1 mg/kg administered twice weekly as a subcutaneous (SC) dose for 4 weeks
MEDI528 3 mg/kg	Experimental	Biological: MEDI528 3 mg/kgMEDI-528 at a dose of 3 mg/kg administered twice weekly as a subcutaneous (SC) dose for 4 weeks
PLACEBO	Placebo comparator	Other: PLACEBOPlacebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks

Who may qualify

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

Key inclusion criteria (12 listed)

Male or female adults, age 18 through 65 years of age at time of screening;
Weight ≤ 100 kg and body mass index ≤ 35;
Written informed consent obtained from the patient prior to receipt of any study medication or beginning study procedures;
Previously documented diagnosis of asthma based on episodic symptoms of airflow obstruction such as wheezing or chest tightness, with alternative diagnoses (e.g., chronic obstructive pulmonary disease) ruled out;
Currently receiving treatment with short-acting β2 agonists, ICS at doses ≤ 264 μg/day fluticasone or equivalent, or both (National Heart, Lung, and Blood Institute [NHLBI], 2002);

Key exclusion criteria (26 listed)

Receipt of MEDI-528 in any previous clinical study or prior randomization into the trial;
History of allergy or reaction to any component of the MEDI-528 formulation;
Lung disease other than persistent asthma (e.g. chronic bronchitis);
FEV1 < 80% of predicted values;
History of severe asthma or asthma exacerbation requiring intubation;

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
MEDI528 0.3 mg/kgMEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a subcutaneous (SC) dose for 4 weeks	Biological	MEDI528 0.3 mg/kg
MEDI528 1 mg/kgMEDI-528 at a dose of 1 mg/kg administered twice weekly as a subcutaneous (SC) dose for 4 weeks	Biological	MEDI528 1 mg/kg
MEDI528 3 mg/kgMEDI-528 at a dose of 3 mg/kg administered twice weekly as a subcutaneous (SC) dose for 4 weeks	Biological	MEDI528 3 mg/kg
PLACEBOPlacebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks	Other	PLACEBO

Primary outcome

Incidence of Adverse Events
Time frame: Days 0 - 150
Number of participants experiencing adverse events (includes both adverse events and serious adverse events)
Incidence of Abnormal Troponin Levels
Time frame: Days 0, 14, 28, 56, 84, and 150
Number of participants with troponin levels greater than upper limit of normal
Incidence of Abnormal Clinically Significant Electrocardiogram (ECG) Results
Time frame: Days -14 to -1, 14, 28, 56, 84, and 150
Number of participants with abnormal clinically significant ECG results
Incidence of Abnormal Clinically Significant Magnetic Resonance Imaging (MRI) Results
Time frame: Days -14 to -1 and 28
Number of participants experiencing abnormal clinically significant MRI results
Incidence of Serious Adverse Events
Time frame: Days 0 - 150
Number of participants experiencing serious adverse events

4 secondary outcomes

Incidence of Anti-drug Antibodies (ADA) to MEDI-528
Time frame: Days 0, 28, 56, 84, 119, and 150
Time to Observed Maximum Serum Concentration (Tmax)
Time frame: Days 0, 3, 7, 10, 14, 17, 21, 24, 26, 28, 31, 35, 42, 49, 56, 70, 84, 119, and 150
Observed Maximum Serum Concentration (Cmax)
Time frame: Days 0, 3, 7, 10, 14, 17, 21, 24, 26, 28, 31, 35, 42, 49, 56, 70, 84, 119, and 150
Terminal Phase Half-life (T1/2)
Time frame: Days 0, 3, 7, 10, 14, 17, 21, 24, 26, 28, 31, 35, 42, 49, 56, 70, 84, 119, and 150

Results and safety

Results posted to the registry on 11 Dec 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PLACEBO	9	8
MEDI528 0.3 mg/kg	9	9
MEDI528 1 mg/kg	9	8
MEDI528 3 mg/kg	9	8

Primary outcome: Incidence of Adverse Events

Time frame: Days 0 - 150. Number. Unit: Participants

Measure	PLACEBO n = 9	MEDI528 0.3 mg/kg n = 9	MEDI528 1 mg/kg n = 9	MEDI528 3 mg/kg n = 9
Value	9	9	9	9

Population analysed: All subjects who received at least one dose of investigational product (MEDI-528 or placebo)

Primary outcome: Incidence of Abnormal Troponin Levels

Time frame: Days 0, 14, 28, 56, 84, and 150. Number. Unit: Participants

Measure	PLACEBO n = 9	MEDI528 0.3 mg/kg n = 9	MEDI528 1 mg/kg n = 9	MEDI528 3 mg/kg n = 9
Value	0	0	0	1

Population analysed: All subjects who received at least one dose of investigational product (MEDI-528 or placebo)

Primary outcome: Incidence of Abnormal Clinically Significant Electrocardiogram (ECG) Results

Time frame: Days -14 to -1, 14, 28, 56, 84, and 150. Number. Unit: Participants

Measure	PLACEBO n = 9	MEDI528 0.3 mg/kg n = 9	MEDI528 1 mg/kg n = 9	MEDI528 3 mg/kg n = 9
Value	0	0	0	0

Population analysed: All subjects who received at least one dose of investigational product (MEDI-528 or placebo)

Primary outcome: Incidence of Abnormal Clinically Significant Magnetic Resonance Imaging (MRI) Results

Time frame: Days -14 to -1 and 28. Number. Unit: Participants

Measure	PLACEBO n = 9	MEDI528 0.3 mg/kg n = 9	MEDI528 1 mg/kg n = 9	MEDI528 3 mg/kg n = 9
Value	0	0	0	0

Population analysed: All subjects who received at least one dose of investigational product (MEDI-528 or placebo)

4 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
PLACEBO	1 of 9 (11.1%)	9 of 9 (100%)	Not reported
MEDI528 0.3 mg/kg	0 of 9 (0%)	9 of 9 (100%)	Not reported
MEDI528 1 mg/kg	0 of 9 (0%)	9 of 9 (100%)	Not reported
MEDI528 3 mg/kg	0 of 9 (0%)	9 of 9 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 21356110Parker JM, Oh CK, LaForce C, Miller SD, Pearlman DS, Le C, Robbie GJ, White WI, White B, Molfino NA; MEDI-528 Clinical Trials Group. Safety profile and clinical activity of multiple subcutaneous doses of MEDI-528, a humanized anti-interleukin-9 monoclonal antibody, in two randomized phase 2a studies in subjects with asthma. BMC Pulm Med. 2011 Feb 28;11:14. doi: 10.1186/1471-2466-11-14.

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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.

Joe Parker, M.D. study director

MedImmune LLC

9 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MEDI528 0.3 mg/kg, MEDI528 1 mg/kg and MEDI528 3 mg/kg in people with Asthma, run by MedImmune LLC at 9 sites in 2 countries.

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 12 inclusion and 26 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 11 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States, Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Dec 2013). 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?

Incidence of Adverse Events (time frame: Days 0 - 150). The study lists 5 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 NCT00507130, 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 11 Dec 2013.