Sickle Cell DiseasePhase 1NCT01430091

A Relative Bioavailability Study of a Prasugrel Orally Disintegrating Tablet

A Phase 1 study testing Prasugrel (clinical formulation) and Prasugrel (Orally Disintegrating Tablet [ODT]) in people with Sickle Cell Disease, run by Eli Lilly and Company at 1 site in United States.

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

This study compares the clinical tablet formulation of prasugrel taken orally with an orally disintegrating tablet (ODT) taken orally. The study will evaluate the amount of prasugrel active metabolite circulating in the blood for each treatment. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Sickle Cell Disease
What is being tested?: Prasugrel (clinical formulation) and Prasugrel (Orally Disintegrating Tablet [ODT])
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteUnited States
Study dates: Sep 2011to Oct 2011
Phase: Phase 1
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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Overtly healthy males or females, as determined by medical history and physical examination
Are either women who are of child-bearing potential, surgically sterilised or defined as post-menopausal. Female subjects of child-bearing potential (not surgically sterilised between menarche and menopause) must have a negative pregnancy test at the time of screening and must be using a reliable method of birth control. These include tubal ligation, an intrauterine device which has been in place for at least 3 months, the oral contraceptive pill which has been taken, without difficulty, for at least 3 months, or an approved hormonal implant. Barrier methods alone (condoms or diaphragm/cap) are not acceptable, but must be used in conjunction with a chemical method, that is, spermicidal gel. A woman is presumed to be post-menopausal if she has had amenorrhoea for greater than 12 months alone or amenorrheic for 6 to 12 months and has a serum oestradiol concentration <73 picomoles per liter (pmol/L) (20 picograms per milliliter [pg/mL]) (not applicable for women on hormone replacement therapy [HRT; oestrogen]) and a follicle stimulating hormone (FSH) concentration >40 international units per liter (IU/L).
Have clinical laboratory test results within normal reference range for the investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
Between the body mass index (BMI) of 18.5 and 32.0 kilograms per meter squared (kg/m^2), inclusive
Have acceptable blood pressure (BP) and heart rate (HR) (supine) as determined by the investigator
Have venous access sufficient to allow blood sampling
Are reliable and willing to make themselves available for the duration of the study, and will abide by the research unit policy and procedure and study restrictions
Have given written informed consent approved by Lilly and the Ethical Review Board (ERB) governing the site

Who cannot join

Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, haematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data, as determined by the investigator
Evidence of significant active neuropsychiatric disease
Have a history or presence of significant bleeding disorders, that is, haematemesis, melaena, severe or recurrent epistaxis, haemoptysis, haemorrhage, clinically overt haematuria, or intracranial haemorrhage
Have a history (within the last 5 years) or presence of gastric ulcers. Previous history of duodenal ulcer is acceptable but must have been successfully surgically or medically treated with no further evidence of disease in the past 6 months (from screening)
Have a personal or family history of coagulation or bleeding disorders or reasonable suspicion of vascular malformations, for example, cerebral haemorrhage, aneurysm, or premature stroke (cerebrovascular accident <65 years of age)
Have a self-reported history of significant bleeding from trauma (for example, prolonged bleeding after tooth extraction)

Show all 25Show fewer

Are pre-menopausal females with a history or presence of menorrhagia within the last 5 years (from screening)
Have clinically significant out of range values for prothrombin time (PT), activated partial thromboplastin time (APTT), or platelet count at screening
Have repeatedly reported positive results (at least 2 separate samples) on the faecal occult blood examination
Have a history of major surgery within 3 months of screening
Have planned surgery within 14 days after the last study day
Have a clinically significant abnormality in fundoscopic examination or petechiae examination
Have any other clinically significant abnormality following the investigator's review of the prestudy physical examination, electrocardiogram (ECG) and clinical (safety) laboratory tests
Regularly use known drugs of abuse and/or show unacceptable positive findings on urinary drug screening
Have known allergies or significant hypersensitivity to prasugrel or related drugs, or a history of relevant allergic drug reactions of any origin
Have donated blood of more than 500 mL within the previous 1 month before prasugrel administration
Show evidence of positive human immunodeficiency virus (HIV) antibodies
Show evidence of positive hepatitis C antibody
Show evidence of positive hepatitis B surface antigen
Have a regular alcohol intake greater than 21 units/week for males or 14 units/week for females or are unwilling to comply with the alcohol consumption requirements from 48 hours prior to the first dose of prasugrel until discharge from the clinical research unit (CRU) after the final Pharmacokinetics (PK) sample of Period 5 has been taken. One unit of alcohol is equal to 8 g ethanol
Smoke 10 or more cigarettes per day
Use prescription, over the counter or herbal medications that cannot safely be discontinued within 14 days prior to prasugrel administration. Exceptions: subjects may continue thyroid replacement therapy, HRT (oestrogen), contraceptives and certain medications that are inhaled or applied to the skin, eyes, or nose. The influenza vaccine may also be administered; however this must be at least 72 hours before any prasugrel dose
Use proton pump inhibitors, antacids, or H2 antagonists, which may impact stomach pH
Have participated in a study involving administration of an investigational compound within the 30 days prior to prasugrel administration
Have any other condition that, in the opinion of the principal investigator increases the risk to the study subject or decreases the likelihood of obtaining reliable results from the study

Trial locations and contacts

1 site in 1 country.

United States1 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.
Honolulu, Hawaii

Other trials in United States

About this study

Official title: Relative Bioavailability of a Prasugrel Paediatric Orally Disintegrating Tablet Formulation Compared to the Tablet in Healthy Adult Subjects

Conditions: Sickle Cell Disease
Being tested: Prasugrel (clinical formulation), Prasugrel (Orally Disintegrating Tablet [ODT])
Medical subject headings: Anemia, Sickle Cell

What participants receive

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

Prasugrel (clinical formulation)Drug
Also called LY640315, Effient®, Efient®
Administered orally
Prasugrel (Orally Disintegrating Tablet [ODT])Drug
Also called LY640315, Effient®, Efient®
Administered orally

Study groups in NCT01430091
Study group	Role	What they receive
Prasugrel clinical formulation	Active comparator	A single 5-milligram (mg) prasugrel tablet administered orally by swallowing it whole on 1 occasion. Receives: Drug: Prasugrel (clinical formulation)
Prasugrel (ODT) - on tongue	Experimental	A single 5-mg prasugrel orally disintegrating tablet (ODT) administered orally by placing it on top of the tongue and keeping it there until it disintegrates. Receives: Drug: Prasugrel (Orally Disintegrating Tablet [ODT])
Prasugrel (ODT) - apple juice	Experimental	A single 5-mg prasugrel ODT administered orally by placing it on top of the tongue followed by drinking approximately 180 milliliters (ml) apple juice within 1 minute after the tablet finishes disintegration. Receives: Drug: Prasugrel (Orally Disintegrating Tablet [ODT])
Prasugrel (ODT) - chewed	Experimental	A single 5-mg prasugrel ODT administered orally by placing it on top of the tongue, but then chewed and swallowed rather than waiting for it to disintegrate. Receives: Drug: Prasugrel (Orally Disintegrating Tablet [ODT])
Prasugrel (ODT) - under tongue	Experimental	A single 5-mg prasugrel ODT administered orally by placing it under (rather than on top of) the tongue and keeping it there until it disintegrates. Receives: Drug: Prasugrel (Orally Disintegrating Tablet [ODT])

What is being measured

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

Pharmacokinetics: Area Under the Concentration-Time Curve From Time Zero to the Last Measureable Concentration (AUC[0-tlast]) of Prasugrel's Active Metabolite (PRAS-AM)
Measured: Pre-dose up to 8 hours post-dose after each treatment
Pharmacokinetics: Maximum Concentration (Cmax) of Prasugrel's Active Metabolite (PRAS-AM)
Measured: Pre-dose up to 8 hours post-dose after each treatment
Pharmacokinetics: Time of Maximum Concentration (Tmax) of Prasugrel's Active Metabolite (PRAS-AM)
Measured: Pre-dose up to 8 hours post-dose after each treatment

Timeline

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

Sep 2011Oct 2011

First posted7 Sep 2011 (estimated)
Study startSep 2011
Primary completionOct 2011
Study completionOct 2011

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.
Other trials for Sickle Cell DiseaseStudies 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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01430091
Sponsor's protocol ID: 13040
Other IDs: H7T-EW-TADQ
Status last verified: Oct 2012
First submitted: 6 Sep 2011
Last updated: 6 Nov 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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

Active, not recruitingPhase 1/2
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Long-term Mitapivat Dosing in Subjects With Stable Sickle Cell Disease: An Extension of a Phase I Pilot Study of Mitapivat
Sickle Cell Disease, Hemolytic Anemia
RecruitingObservational study
HPC Offered for PRESERVE Expansion
Bone Marrow Transplant (BMT)
RecruitingPhase 1
Study to Evaluate the Safety and Tolerability of Escalating Doses of Fostamatinib in Subjects With Stable Sickle Cell Disease
Sickle Cell Disorders, Sickle Cell Disease
RecruitingPhase 4
Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease
Sickle Cell Disease (SCD), Vaso-Occlusive Pain Episode in Sickle Cell Disease
Not yet recruitingPhase 1
Buprenorphine for the Management of Pain in Children With Sickle Cell Disease
Sickle Cell Disease (SCD), Sickle Cell Disease Vaso-occlusive Crisis

All Sickle Cell Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Relative Bioavailability of a Prasugrel Paediatric Orally Disintegrating Tablet Formulation Compared to the Tablet in Healthy Adult Subjects
ClinicalTrials.gov ID: NCT01430091
Acronym / sponsor ID: 13040
Conditions: Sickle Cell Disease
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Sep 2011
Primary completion: Oct 2011 (actual)
Study completion: Oct 2011 (actual)
First posted: 7 Sep 2011 (estimated)
Results: Posted 6 Nov 2012

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: Crossover
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Prasugrel clinical formulation	Active comparator	Drug: Prasugrel (clinical formulation)A single 5-milligram (mg) prasugrel tablet administered orally by swallowing it whole on 1 occasion.
Prasugrel (ODT) - on tongue	Experimental	Drug: Prasugrel (Orally Disintegrating Tablet [ODT])A single 5-mg prasugrel orally disintegrating tablet (ODT) administered orally by placing it on top of the tongue and keeping it there until it disintegrates.
Prasugrel (ODT) - apple juice	Experimental	Drug: Prasugrel (Orally Disintegrating Tablet [ODT])A single 5-mg prasugrel ODT administered orally by placing it on top of the tongue followed by drinking approximately 180 milliliters (ml) apple juice within 1 minute after the tablet finishes disintegration.
Prasugrel (ODT) - chewed	Experimental	Drug: Prasugrel (Orally Disintegrating Tablet [ODT])A single 5-mg prasugrel ODT administered orally by placing it on top of the tongue, but then chewed and swallowed rather than waiting for it to disintegrate.
Prasugrel (ODT) - under tongue	Experimental	Drug: Prasugrel (Orally Disintegrating Tablet [ODT])A single 5-mg prasugrel ODT administered orally by placing it under (rather than on top of) the tongue and keeping it there until it disintegrates.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Overtly healthy males or females, as determined by medical history and physical examination
Are either women who are of child-bearing potential, surgically sterilised or defined as post-menopausal. Female subjects of child-bearing potential (not surgically sterilised between menarche and menopause) must have a negative pregnancy test at the time of screening and must be using a reliable method of birth control. These include tubal ligation, an intrauterine device which has been in place for at least 3 months, the oral contraceptive pill which has been taken, without difficulty, for at least 3 months, or an approved hormonal implant. Barrier methods alone (condoms or diaphragm/cap) are not acceptable, but must be used in conjunction with a chemical method, that is, spermicidal gel. A woman is presumed to be post-menopausal if she has had amenorrhoea for greater than 12 months alone or amenorrheic for 6 to 12 months and has a serum oestradiol concentration <73 picomoles per liter (pmol/L) (20 picograms per milliliter [pg/mL]) (not applicable for women on hormone replacement therapy [HRT; oestrogen]) and a follicle stimulating hormone (FSH) concentration >40 international units per liter (IU/L).
Have clinical laboratory test results within normal reference range for the investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
Between the body mass index (BMI) of 18.5 and 32.0 kilograms per meter squared (kg/m^2), inclusive
Have acceptable blood pressure (BP) and heart rate (HR) (supine) as determined by the investigator

Key exclusion criteria (25 listed)

Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, haematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data, as determined by the investigator
Evidence of significant active neuropsychiatric disease
Have a history or presence of significant bleeding disorders, that is, haematemesis, melaena, severe or recurrent epistaxis, haemoptysis, haemorrhage, clinically overt haematuria, or intracranial haemorrhage
Have a history (within the last 5 years) or presence of gastric ulcers. Previous history of duodenal ulcer is acceptable but must have been successfully surgically or medically treated with no further evidence of disease in the past 6 months (from screening)
Have a personal or family history of coagulation or bleeding disorders or reasonable suspicion of vascular malformations, for example, cerebral haemorrhage, aneurysm, or premature stroke (cerebrovascular accident <65 years of age)

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
Prasugrel (clinical formulation)Also: LY640315, Effient®, Efient®Administered orally	Drug	Prasugrel clinical formulation
Prasugrel (Orally Disintegrating Tablet [ODT])Also: LY640315, Effient®, Efient®Administered orally	Drug	Prasugrel (ODT) - apple juice, Prasugrel (ODT) - chewed, Prasugrel (ODT) - on tongue, Prasugrel (ODT) - under tongue

Primary outcome

Pharmacokinetics: Area Under the Concentration-Time Curve From Time Zero to the Last Measureable Concentration (AUC[0-tlast]) of Prasugrel's Active Metabolite (PRAS-AM)
Time frame: Pre-dose up to 8 hours post-dose after each treatment
Pharmacokinetics: Maximum Concentration (Cmax) of Prasugrel's Active Metabolite (PRAS-AM)
Time frame: Pre-dose up to 8 hours post-dose after each treatment
Pharmacokinetics: Time of Maximum Concentration (Tmax) of Prasugrel's Active Metabolite (PRAS-AM)
Time frame: Pre-dose up to 8 hours post-dose after each treatment

Results and safety

Results posted to the registry on 6 Nov 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Participants	18	18

Primary outcome: Pharmacokinetics: Area Under the Concentration-Time Curve From Time Zero to the Last Measureable Concentration (AUC[0-tlast]) of Prasugrel's Active Metabolite (PRAS-AM)

Time frame: Pre-dose up to 8 hours post-dose after each treatment. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram * hour per milliliter (ng*h/mL)

Measure	Clinical Tablet n = 18	ODT on Top of Tongue n = 18	ODT on Top of Tongue With Juice Chaser n = 18	ODT Chewed and Swallowed n = 18	ODT Placed Under the Tongue n = 18
Value	43.3 (27.0)	42.7 (25.0)	42.3 (29)	41.0 (32)	42.0 (30)

Population analysed: Pharmacokinetic analyses were conducted on the full analysis set, which included all data from all randomized participants receiving at least 1 dose of prasugrel.

Primary outcome: Pharmacokinetics: Maximum Concentration (Cmax) of Prasugrel's Active Metabolite (PRAS-AM)

Time frame: Pre-dose up to 8 hours post-dose after each treatment. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram per milliliter (ng/mL)

Measure	Clinical Tablet n = 18	ODT on Top of Tongue n = 18	ODT on Top of Tongue With Juice Chaser n = 18	ODT Chewed and Swallowed n = 18	ODT Placed Under the Tongue n = 18
Value	47.3 (48)	47.6 (19)	32.3 (37)	38.3 (47)	41.9 (37)

Population analysed: Pharmacokinetic analyses were conducted on the full analysis set, which included all data from all randomized participants receiving at least 1 dose of prasugrel.

Primary outcome: Pharmacokinetics: Time of Maximum Concentration (Tmax) of Prasugrel's Active Metabolite (PRAS-AM)

Time frame: Pre-dose up to 8 hours post-dose after each treatment. Median (Full Range). Unit: hours

Measure	Clinical Tablet n = 18	ODT on Top of Tongue n = 18	ODT on Top of Tongue With Juice Chaser n = 18	ODT Chewed and Swallowed n = 18	ODT Placed Under the Tongue n = 18
Value	0.50 (0.25 to 1.00)	0.50 (0.25 to 2.00)	0.75 (0.25 to 1.50)	0.75 (0.25 to 2.00)	0.50 (0.25 to 2.00)

Population analysed: Pharmacokinetic analyses were conducted on the full analysis set, which included all data from all randomized participants receiving at least 1 dose of prasugrel.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Clinical Tablet	0 of 18 (0%)	2 of 18 (11.1%)	Not reported
ODT (Top of Tongue)	0 of 18 (0%)	3 of 18 (16.7%)	Not reported
ODT (Juice Chaser)	0 of 18 (0%)	1 of 18 (5.6%)	Not reported
ODT (Chew and Swallow)	0 of 18 (0%)	0 of 18 (0%)	Not reported
ODT (Under Tongue)	0 of 18 (0%)	0 of 18 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Sickle Cell Disease

Active, not recruitingPhase 1/2
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Long-term Mitapivat Dosing in Subjects With Stable Sickle Cell Disease: An Extension of a Phase I Pilot Study of Mitapivat
Sickle Cell Disease, Hemolytic Anemia
RecruitingObservational study
HPC Offered for PRESERVE Expansion
Bone Marrow Transplant (BMT)
RecruitingPhase 1
Study to Evaluate the Safety and Tolerability of Escalating Doses of Fostamatinib in Subjects With Stable Sickle Cell Disease
Sickle Cell Disorders, Sickle Cell Disease
RecruitingPhase 4
Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease
Sickle Cell Disease (SCD), Vaso-Occlusive Pain Episode in Sickle Cell Disease
Not yet recruitingPhase 1
Buprenorphine for the Management of Pain in Children With Sickle Cell Disease
Sickle Cell Disease (SCD), Sickle Cell Disease Vaso-occlusive Crisis

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 - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

1 site in 1 country: 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 8 inclusion and 25 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 6 Nov 2012. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 6 Nov 2012). 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?

Pharmacokinetics: Area Under the Concentration-Time Curve From Time Zero to the Last Measureable Concentration (AUC[0-tlast]) of Prasugrel's Active Metabolite (PRAS-AM) (time frame: Pre-dose up to 8 hours post-dose after each treatment). The study lists 3 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 NCT01430091.

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 6 Nov 2012.