HypoglycemiaPhase 1NCT00745186
Pharmacokinetics (PK) and Pharmacodynamics (PD) of Mayne Glucagon for Injection Compared With Glucagen® (Novo Nordisk) in Healthy Volunteers
A Phase 1 study testing Glucagen and Mayne Glucagon in people with Hypoglycemia, run by Hospira, now a wholly owned subsidiary of Pfizer at 1 site in United Kingdom.
Trial summary
The purpose of this study is to evaluate the pharmacokinetics and pharmacodynamic bioequivalence and safety of Hospira Glucagon for Injection and GlucaGen® in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoglycemia
- What is being tested?
- Glucagen and Mayne Glucagon
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2007to Mar 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Male or female aged 18-50 years inclusive
- Body weight between 50 - 100 kg and body mass index (BMI) between 18 and 30 kg/m2 or, if outside the range, considered not clinically significant by the investigator
- Non-smokers or ex-smokers who have not smoked with in the previous 3 months
- Written informed consent given
- Willing and able to comply with the requirements of the protocol and available for the planned duration of the study
- Subject must agree to use an adequate method of contraception during the study and for 12 weeks after the last dose of investigational medicinal product (IMP). Adequate methods of contraception for subject or partner include condoms with spermicide gel, diaphragm with spermicide gel, coil (intrauterine device), surgical sterilisation, subdermal implant, vasectomy, oral contraceptive pill, depot progesterone injections and abstinence. If a volunteer is usually not sexually active but becomes active he/she or their partner must use one of the contraceptive methods listed . Male subjects whose partner is of child bearing potential must ensure that they or their partner use effective contraception for the course of the study and 12 weeks thereafter
Who cannot join
- History or presence of any clinically significant findings that, in the opinion of the investigator, would preclude inclusion in the study
- History or presence of clinical significant gastrointestinal pathology or symptoms, liver or kidney disease or any other condition that might interfere with the absorption, distribution, metabolism or excretion of the drug.
- Any clinically significant laboratory findings
- Clinically significant abnormalities in 12-lead electrocardiogram (ECG) results
- Positive pregnancy test or lactation
- Participation in any other clinical study using an investigational product or device within the previous 12 weeks
Show all 11Show fewer
- Positive human immunodeficiency virus (HIV), Hepatitis B or C test
- History of drug or alcohol abuse within the past two years or alcohol consumption greater than 21 units per week for males and greater than 14 units per week for females
- Blood donation of ≥ 500 mL in the previous 12 weeks
- Hypersensitivity to Glucagon and/or any excipients
- Use of prescription medicines or St John's Wort in the previous 2 weeks. The use of over-the-counter medicines within 5 days of dosing except those deemed by the investigator not to interfere with the outcome of the study. Vitamins, minerals and nutritional supplements may be taken at the discretion of the investigator. Hormonal contraceptives will be permitted.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open Label, Four Way Crossover Study to Compare the Pharmacokinetics, Pharmacodynamics and Safety After Intramuscular (IM) Administration of Mayne Glucagon for Injection With Glucagen® (Novo Nordisk) in Healthy Volunteers.
The purpose of this study is to evaluate the pharmacokinetics and pharmacodynamic bioequivalence and safety of Hospira Glucagon for Injection and GlucaGen® in healthy volunteers.
Read the detailed description
Glucagon has been shown to be effective in the treatment of hypoglycemia, low blood sugar levels, in patients with diabetes. It primarily functions as a counter-regulatory hormone by opposing the actions of insulin to maintain blood glucose levels. A major problem for diabetic patients with hypoglycemia is the development of defective counter regulatory responses including reduced or absent glucagon responses to hypoglycemia. Mayne Glucagon for Injection has been developed as an alternative to currently marketed products.
Administration of exogenous glucagon i.e., not produced in the body, has been shown to be effective in the treatment of low blood sugar in patients with diabetes. Mayne has developed a product, Glucagon for Injection, which is an alternative to currently marketed products. The only difference is the source of the active ingredient. The formulation, routes of administration, dosage regimen and indications of Mayne Glucagon for Injection are identical to those currently registered for the marketed product.
A total of 28 healthy volunteers will be recruited into this study at one investigational site.
- Conditions
- Hypoglycemia
- Being tested
- Glucagen, Mayne Glucagon
- Medical subject headings
- Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlucagenDrug
0.2 mg or 1 mg Glucagen single injection
Mayne GlucagonDrug
0.2 mg or 1 mg Mayne Glucagon
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Glucagen Receives: Drug: Glucagen |
| 2 | Experimental | Mayne Glucagon Receives: Drug: Mayne Glucagon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve from Time 0 to the Last Time Point (AUC0-tlast) for 1 mg Dose Level
Measured: Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90, 120, 150, 180 and 240 minutes.
Maximum Glucagon Concentration Observed (Cmax) for 1 mg Dose Level
Measured: Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90, 120, 150, 180 and 240 minutes.
Maximum Blood Glucose Concentration Observed (BG Cmax) for 1 mg Dose Level
Measured: Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20,25,30, 35, 40, 45, 60, 90, 120, 150, 180 and 240 minutes.
Secondary outcomes (19)
Area under the curve from time 0 extrapolated to infinity (AUC0-inf) for 1 mg Dose Level
Measured: Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90, 120, 150, 180 and 240 minutes.
Time at which Cmax occurs (Tmax) for 1 mg Dose Level
Measured: Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90, 120, 150, 180 and 240 minutes.
Elimination half life (T1/2) for 1 mg Dose Level
Measured: Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20,25, 30, 35, 40, 45, 60, 90, 120, 150, 180 and 240 minutes.
Area Under the Curve from Time 0 to the Last Time Point (AUC0-tlast) for 0.2 mg Dose Level
Measured: Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90 and 120 minutes.
Maximum Glucagon Concentration Observed (Cmax) for 0.2 mg Dose Level
Measured: Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90 and 120 minutes.
Area under the curve from time 0 extrapolated to infinity (AUC0-inf) for 0.2 mg Dose Level
Measured: Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90 and 120 minutes.
Time at which Cmax occurs (Tmax) for 0.2 mg Dose Level
Measured: Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90 and 120 minutes.
Elimination half-life (T1/2) for 0.2 mg Dose Level
Measured: Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90 and 120 minutes.
Time at which Blood Glucose Cmax occurs (BG Tmax) for 1 mg Dose Level
Measured: Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90, 120, 150, 180 and 240 minutes.
Area under the curve from time 0 to return to baseline (rtb) for 1 mg Dose Level
Measured: Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90, 120, 150, 180 and 240 minutes.
Maximum absolute Blood Glucose excursion (MAE) from baseline for 1 mg Dose Level
Measured: Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90, 120, 150, 180 and 240 minutes.
Area under the glucose excursion versus time curve from 0 to rtb for 1 mg Dose Level
Measured: Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90, 120, 150, 180 and 240 minutes.
The earliest recorded time of the MAE for 1 mg Dose Level
Measured: Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90, 120, 150, 180 and 240 minutes.
Maximum Blood Glucose Concentration Observed (BG Cmax) for 0.2 mg Dose Level
Measured: Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90 and 120 minutes.
Time at which Blood Glucose Cmax occurs (BG Tmax) for 0.2 mg Dose Level
Measured: Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90 and 120 minutes.
Area under the curve from time 0 to return to baseline (rtb) for 0.2 mg Dose Level
Measured: Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90 and 120 minutes.
Maximum absolute Blood Glucose excursion (MAE) from baseline for 0.2 mg Dose Level
Measured: Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90 and 120 minutes.
Area under the glucose excursion versus time curve from 0 to rtb for 0.2 mg Dose Level
Measured: Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90 and 120 minutes.
The earliest recorded time of the MAE for 0.2 mg Dose Level
Measured: Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90 and 120 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2008 (estimated)
- Study startAug 2007
- Primary completionOct 2007
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoglycemiaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stuart Mair, Principal investigator, Syneos Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00745186
- Sponsor's protocol ID
- GLC061
- Status last verified
- Jun 2015
- First submitted
- 2 Sep 2008
- Last updated
- 20 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Four Way Crossover Study to Compare the Pharmacokinetics, Pharmacodynamics and Safety After Intramuscular (IM) Administration of Mayne Glucagon for Injection With Glucagen® (Novo Nordisk) in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT00745186
- Acronym / sponsor ID
- GLC061
- Conditions
- Hypoglycemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Hospira, now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Oct 2007 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 3 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the pharmacokinetics and pharmacodynamic bioequivalence and safety of Hospira Glucagon for Injection and GlucaGen® in healthy volunteers.
Detailed description
Glucagon has been shown to be effective in the treatment of hypoglycemia, low blood sugar levels, in patients with diabetes. It primarily functions as a counter-regulatory hormone by opposing the actions of insulin to maintain blood glucose levels. A major problem for diabetic patients with hypoglycemia is the development of defective counter regulatory responses including reduced or absent glucagon responses to hypoglycemia. Mayne Glucagon for Injection has been developed as an alternative to currently marketed products.
Administration of exogenous glucagon i.e., not produced in the body, has been shown to be effective in the treatment of low blood sugar in patients with diabetes. Mayne has developed a product, Glucagon for Injection, which is an alternative to currently marketed products. The only difference is the source of the active ingredient. The formulation, routes of administration, dosage regimen and indications of Mayne Glucagon for Injection are identical to those currently registered for the marketed product.
A total of 28 healthy volunteers will be recruited into this study at one investigational site.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: GlucagenGlucagen |
| 2 | Experimental | Drug: Mayne GlucagonMayne Glucagon |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy Male or female aged 18-50 years inclusive
- Body weight between 50 - 100 kg and body mass index (BMI) between 18 and 30 kg/m2 or, if outside the range, considered not clinically significant by the investigator
- Non-smokers or ex-smokers who have not smoked with in the previous 3 months
- Written informed consent given
- Willing and able to comply with the requirements of the protocol and available for the planned duration of the study
Key exclusion criteria (11 listed)
- History or presence of any clinically significant findings that, in the opinion of the investigator, would preclude inclusion in the study
- History or presence of clinical significant gastrointestinal pathology or symptoms, liver or kidney disease or any other condition that might interfere with the absorption, distribution, metabolism or excretion of the drug.
- Any clinically significant laboratory findings
- Clinically significant abnormalities in 12-lead electrocardiogram (ECG) results
- Positive pregnancy test or lactation
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 |
|---|---|---|
| Glucagen0.2 mg or 1 mg Glucagen single injection | Drug | 1 |
| Mayne Glucagon0.2 mg or 1 mg Mayne Glucagon | Drug | 2 |
Primary outcome
Area Under the Curve from Time 0 to the Last Time Point (AUC0-tlast) for 1 mg Dose Level
Time frame: Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90, 120, 150, 180 and 240 minutes.
Maximum Glucagon Concentration Observed (Cmax) for 1 mg Dose Level
Time frame: Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90, 120, 150, 180 and 240 minutes.
Maximum Blood Glucose Concentration Observed (BG Cmax) for 1 mg Dose Level
Time frame: Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20,25,30, 35, 40, 45, 60, 90, 120, 150, 180 and 240 minutes.
19 secondary outcomes
Area under the curve from time 0 extrapolated to infinity (AUC0-inf) for 1 mg Dose Level
Time frame: Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90, 120, 150, 180 and 240 minutes.
Time at which Cmax occurs (Tmax) for 1 mg Dose Level
Time frame: Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90, 120, 150, 180 and 240 minutes.
Elimination half life (T1/2) for 1 mg Dose Level
Time frame: Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20,25, 30, 35, 40, 45, 60, 90, 120, 150, 180 and 240 minutes.
Area Under the Curve from Time 0 to the Last Time Point (AUC0-tlast) for 0.2 mg Dose Level
Time frame: Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90 and 120 minutes.
Maximum Glucagon Concentration Observed (Cmax) for 0.2 mg Dose Level
Time frame: Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90 and 120 minutes.
Area under the curve from time 0 extrapolated to infinity (AUC0-inf) for 0.2 mg Dose Level
Time frame: Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90 and 120 minutes.
Time at which Cmax occurs (Tmax) for 0.2 mg Dose Level
Time frame: Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90 and 120 minutes.
Elimination half-life (T1/2) for 0.2 mg Dose Level
Time frame: Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90 and 120 minutes.
Time at which Blood Glucose Cmax occurs (BG Tmax) for 1 mg Dose Level
Time frame: Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90, 120, 150, 180 and 240 minutes.
Area under the curve from time 0 to return to baseline (rtb) for 1 mg Dose Level
Time frame: Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90, 120, 150, 180 and 240 minutes.
Maximum absolute Blood Glucose excursion (MAE) from baseline for 1 mg Dose Level
Time frame: Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90, 120, 150, 180 and 240 minutes.
Area under the glucose excursion versus time curve from 0 to rtb for 1 mg Dose Level
Time frame: Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90, 120, 150, 180 and 240 minutes.
The earliest recorded time of the MAE for 1 mg Dose Level
Time frame: Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90, 120, 150, 180 and 240 minutes.
Maximum Blood Glucose Concentration Observed (BG Cmax) for 0.2 mg Dose Level
Time frame: Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90 and 120 minutes.
Time at which Blood Glucose Cmax occurs (BG Tmax) for 0.2 mg Dose Level
Time frame: Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90 and 120 minutes.
Area under the curve from time 0 to return to baseline (rtb) for 0.2 mg Dose Level
Time frame: Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90 and 120 minutes.
Maximum absolute Blood Glucose excursion (MAE) from baseline for 0.2 mg Dose Level
Time frame: Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90 and 120 minutes.
Area under the glucose excursion versus time curve from 0 to rtb for 0.2 mg Dose Level
Time frame: Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90 and 120 minutes.
The earliest recorded time of the MAE for 0.2 mg Dose Level
Time frame: Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90 and 120 minutes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2017.
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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.
Stuart Mair principal investigator
Syneos Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Glucagen and Mayne Glucagon in people with Hypoglycemia, run by Hospira, now a wholly owned subsidiary of Pfizer at 1 site in United Kingdom.
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 6 inclusion and 11 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 20 Mar 2017. 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 Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Area Under the Curve from Time 0 to the Last Time Point (AUC0-tlast) for 1 mg Dose Level (time frame: Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90, 120, 150, 180 and 240 minutes.). 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?
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 20 Mar 2017.