Chronic Renal FailurePhase 1NCT01170078

A Study Comparing the Effects of Epoetin Hospira and Epogen/Epoetin Alfa (Amgen) When Administered IV in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment

A Phase 1 study testing Epoetin Hospira and Epogen in people with Chronic Renal Failure, run by Hospira, now a wholly owned subsidiary of Pfizer at 20 sites 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 assessed the comparability of the pharmacokinetics (PK) of epoetin following intravenous administration of Hospira Epoetin and Epogen/Epoetin Alfa (Amgen) in patients with chronic renal failure receiving hemodialysis treatment. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Chronic Renal Failure
What is being tested?: Epoetin Hospira and Epogen
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 107 participants
Where: 20 sitesUnited States
Study dates: Jul 2010to Jan 2011
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Able to provide written informed consent after risks and benefits of the study have been explained prior to any study related activities.
Males and females between 18 and 75 years of age (both inclusive).
Hemodialysis patients with chronic renal failure and anemia currently on stable epoetin treatment for at least 4 weeks prior to the Day 1 of Pre-treatment where during this period:
Epogen/Epoetin Alfa (Amgen) dose has been administered IV, 3 times a week and where each dose is <= 200 International Units(IU)/KG.
Hb levels were maintained within the 10-12 g/dL, with no more than a 0.5 g/dL change from the mean over this period.
No dose change during the last 4 weeks prior to Day 1 of pre-treatment period.

Show all 13Show fewer

Subjects on stable, adequate dialysis for at least 12 weeks prior to randomization, defined as no clinically relevant changes of dialysis regimen and/or dialyzer.
Subjects with adequate iron stores, defined as serum ferritin >= 100 µg/L and transferrin saturation (TSAT) >20% prior to randomization.
If female, subject must be postmenopausal for at lest 1 year prior to randomization, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or practicing at least one of the following forms of birth control:
hormonal contraceptives (oral, parenteral or transdermal) for at least 3 months prior to randomization.
intrauterine device (IUD)
double-barrier method (condoms, contraceptive sponge, diaphragm or vaginal ring with spermicidal jellies or cream).
If hormonal contraceptives are used, the specific contraceptive must have been used for at least 3 months prior to randomization. If the subject is currently using a hormonal contraceptive, she should also use a barrier method during this study and for 1 month after last dose of Study Medication (Dosing Day 3 of Treatment Period 2).

Who cannot join

A subject with any active, uncontrolled systemic disease that in the investigator's opinion may be significant to exclude participation in the study , including but not limited to microbial, viral or fungal infection or mental disease (including demyelinating diseases such as multiple sclerosis).
History of drug abuse or alcohol abuse within 2 years prior to randomization as determined by the Investigator or a positive serum or saliva drug screen during the Screening Period or on Day 1 of each Treatment Period.
Significant drug sensitivity or a significant allergic reaction to any drug, as well as known hypersensitivity or idiosyncratic reaction to epoetin (or it's excipients, including albumin) or any other related drugs.
A subject who in the Investigator's opinion, has any clinically significant abnormal laboratory evaluations, including Human Immunodeficiency Virus (HIV), Hepatitis B virus surface antigen (HBsAg) and liver function taken at Screening Visit.
Current treatment with long-acting epoetin analogues such as Aranesp.
The following within 6 months prior to randomization: unstable congestive heart failure (New York Heart Association [NYHA] class III or IV), cerebrovascular accident, myocardial infarction, coronary angioplasty or by-pass surgery.

Show all 14Show fewer

Uncontrolled hypertension in Investigator's opinion within 4 weeks prior to randomization.
A subject who has received a recent (within last 6 months) live or attenuated vaccination (except flu vaccination).
A female subject who is pregnant, nursing, or planning a pregnancy during the study.
Donated or lost >= 457 ml (i.e., 1 pint) blood volume (including plasmapheresis) or had a transfusion of any blood product within 3 months prior to randomization.
Known clinically manifested untreated deficiency of folic acid and/or vitamin B12.
Current participation or participation in a drug or other investigational research study within 30 days prior to randomization.
May not be able to comply with the requirements of this clinical trial, communicate effectively with study personnel, or is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.
Known positive test for anti-epoetin antibodies.

Trial locations and contacts

20 sites in 1 country.

City, postcode or hospital

20 sites in 1 country

United States20 sites

Study site
Alexandria, Virginia, 22306
Study site
Columbia, South Carolina, 29203
Study site
Denver, Colorado, 80230
Study site
Detroit, Michigan, 48236
Study site
Downey, California, 90241
Study site
Gulfport, Mississippi, 39501
Study site
Gurnee, Illinois, 60031
Study site
Houston, Texas, 77054
Study site
Houston, Texas, 77099
Study site
Knoxville, Tennessee, 37923
Study site
Lauderdale Lakes, Florida, 33313
Study site
Miami, Florida, 33150
Study site
Miami, Florida, 33173
Study site
Middlebury, Connecticut, 06762
Study site
Minneapolis, Minnesota, 55404
Study site
Philadelphia, Pennsylvania, 19106
Study site
Pontiac, Michigan, 48341
Study site
San Antonio, Texas, 78229
Study site
Tarzana, California, 91356-6123
Study site
Wichita, Kansas, 67214

Other trials in United States

About this study

Official title: A Phase 1 Study Comparing the Pharmacokinetics of Epoetin Hospira and Epoetin Alfa (Amgen) When Administered Intravenously in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment

Read the detailed description

This is a multicenter, active-controlled, cross-over, evaluator-blind, Phase I study in patients with chronic renal failure requiring hemodialysis. The study comprises a 4-week Screening Period, a 1-week Pre-Treatment Period, a 1-week Treatment Period 1, a 1-week Treatment Period 2 and a Follow-up visit at Week 7.

Subject eligibility will be determined during the 4-week Screening Period. All subjects must be optimally titrated and stable to qualify for entry into Pre-Treatment Period.

During the 1-week Pre-treatment period the patients will continue on the same stable dose as they received during the Screening Period. Blood samples will be collected during the Pre-Treatment Period to assess pharmacokinetics of Epogen. Eligible subjects will be randomized at Day 1 of Treatment Period 1 to receive either Epoetin Hospira or Epogen (Amgen) by intravenous (IV) bolus injections administered three times a week for 1 week.

Subjects will then be switched to receive the alternate study drug for three times a week for 1 week in Treatment Period 2. Blood samples will be collected during Treatment periods 1 and 2 to assess pharmacokinetics of Epoetin Hospira and Epogen.

Primary endpoint, i.e. pharmacokinetics concentrations, will be evaluator blinded. After completing Treatment Period 2, all subjects will receive standard of care treatment and will undergo a Follow-up Visit at Week 7 (i.e., 28 days after Treatment Period 2).

Conditions: Chronic Renal Failure
Being tested: Epoetin Hospira, Epogen
Keywords: chronic renal failure requiring hemodialysis
Medical subject headings: Kidney Failure, Chronic

What participants receive

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

Epoetin HospiraDrug
IV dose 3 times a week.
EpogenDrug
IV dose 3 times a week

Study groups in NCT01170078
Study group	Role	What they receive
Arm A: Epoetin Hospira administered IV for three doses	Experimental	Not described Receives: Drug: Epoetin Hospira
Arm B: Epogen administered IV for three doses	Active comparator	Not described Receives: Drug: Epogen

What is being measured

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

Baseline-adjusted area under the serum epoetin concentration curve from the time of dose administration to 48 hours (AUC0-48)
Measured: On Day 1 and 2 of Pre-Treatment and Treatment Periods 1 and 2 predose (0 hour). On Day 3 of Pre-Treatment Period and Treatment Periods 1 and 2 (i.e., 3rd epoetin dose of the week) at predose (0 hour) and postdose (0.5, 1, 2, 4, 6, 8, 12, 24 and 48 hours)
Maximum serum epoetin concentration (Cmax)
Measured: On Day 1 and 2 of Pre-Treatment and Treatment Periods 1 and 2 predose (0 hour). On Day 3 of Pre-Treatment Period and Treatment Periods 1 and 2 (i.e., 3rd epoetin dose of the week) at predose (0 hour) and postdose (0.5, 1, 2, 4, 6, 8, 12, 24 and 48 hours)
AUC from time of dose administration to the time of the last measurable concentration (AUC0-t)
If AUC0-48 cannot be calculated then AUC from time of dose administration to the time of the last measurable concentration (AUC0-t) will be used as the primary measure.
Measured: On Day 1 and 2 of Pre-Treatment and Treatment Periods 1 and 2 predose (0 hour). On Day 3 of Pre-Treatment Period and Treatment Periods 1 and 2 (i.e., 3rd epoetin dose of the week) at predose (0 hour) and postdose (0.5, 1, 2, 4, 6, 8, 12, 24 and 48 hours)

Secondary outcomes (6)

Dose-adjusted Cmax
Measured: On Day 1 and 2 of Pre-Treatment and Treatment Periods 1 and 2 predose (0 hour). On Day 3 of Pre-Treatment Period and Treatment Periods 1 and 2 (i.e., 3rd epoetin dose of the week) at predose (0 hour) and postdose (0.5, 1, 2, 4, 6, 8, 12, 24 and 48 hours)
AUC from time of dose administration to the time of the last measurable concentration (AUC0-t)
Measured: On Day 1 and 2 of Pre-Treatment and Treatment Periods 1 and 2 predose (0 hour). On Day 3 of Pre-Treatment Period and Treatment Periods 1 and 2 (i.e., 3rd epoetin dose of the week) at predose (0 hour) and postdose (0.5, 1, 2, 4, 6, 8, 12, 24 and 48 hours)
Elimination rate Constant (λz)
Measured: On Day 1 and 2 of Pre-Treatment and Treatment Periods 1 and 2 predose (0 hour). On Day 3 of Pre-Treatment Period and Treatment Periods 1 and 2 (i.e., 3rd epoetin dose of the week) at predose (0 hour) and postdose (0.5, 1, 2, 4, 6, 8, 12, 24 and 48 hours)
Elimination halflife (t1/2)
Measured: On Day 1 and 2 of Pre-Treatment and Treatment Periods 1 and 2 predose (0 hour). On Day 3 of Pre-Treatment Period and Treatment Periods 1 and 2 (i.e., 3rd epoetin dose of the week) at predose (0 hour) and postdose (0.5, 1, 2, 4, 6, 8, 12, 24 and 48 hours)
Clearance (CL)
Measured: On Day 1 and 2 of Pre-Treatment and Treatment Periods 1 and 2 predose (0 hour). On Day 3 of Pre-Treatment Period and Treatment Periods 1 and 2 (i.e., 3rd epoetin dose of the week) at predose (0 hour) and postdose (0.5, 1, 2, 4, 6, 8, 12, 24 and 48 hours)
Volume of Distribution (Vd)
Measured: On Day 1 and 2 of Pre-Treatment and Treatment Periods 1 and 2 predose (0 hour). On Day 3 of Pre-Treatment Period and Treatment Periods 1 and 2 (i.e., 3rd epoetin dose of the week) at predose (0 hour) and postdose (0.5, 1, 2, 4, 6, 8, 12, 24 and 48 hours)

Timeline

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

Jul 2010Jan 2011

First posted27 Jul 2010 (estimated)
Study startJul 2010
Primary completionJan 2011
Study completionJan 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic Renal FailureStudies 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: Single blind
Who is masked: Outcomes assessor
Enrolment: 107 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01170078
Sponsor's protocol ID: EPOE-10-08
Status last verified: Jun 2015
First submitted: 23 Jul 2010
Last updated: 20 Mar 2017
Results posted: No
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 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases

All Chronic Renal Failure trials

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 Phase 1 Study Comparing the Pharmacokinetics of Epoetin Hospira and Epoetin Alfa (Amgen) When Administered Intravenously in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment
ClinicalTrials.gov ID: NCT01170078
Acronym / sponsor ID: EPOE-10-08
Conditions: Chronic Renal Failure
Keywords: chronic renal failure requiring hemodialysis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 107 participants (actual)
Lead sponsor: Hospira, now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
Study start: Jul 2010
Primary completion: Jan 2011 (actual)
Study completion: Jan 2011 (actual)
First posted: 27 Jul 2010 (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.

Detailed description

Subject eligibility will be determined during the 4-week Screening Period. All subjects must be optimally titrated and stable to qualify for entry into Pre-Treatment Period.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Arm A: Epoetin Hospira administered IV for three doses	Experimental	Drug: Epoetin Hospira
Arm B: Epogen administered IV for three doses	Active comparator	Drug: Epogen

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Able to provide written informed consent after risks and benefits of the study have been explained prior to any study related activities.
Males and females between 18 and 75 years of age (both inclusive).
Hemodialysis patients with chronic renal failure and anemia currently on stable epoetin treatment for at least 4 weeks prior to the Day 1 of Pre-treatment where during this period:
Subjects on stable, adequate dialysis for at least 12 weeks prior to randomization, defined as no clinically relevant changes of dialysis regimen and/or dialyzer.
Subjects with adequate iron stores, defined as serum ferritin >= 100 µg/L and transferrin saturation (TSAT) >20% prior to randomization.

Key exclusion criteria (14 listed)

A subject with any active, uncontrolled systemic disease that in the investigator's opinion may be significant to exclude participation in the study , including but not limited to microbial, viral or fungal infection or mental disease (including demyelinating diseases such as multiple sclerosis).
History of drug abuse or alcohol abuse within 2 years prior to randomization as determined by the Investigator or a positive serum or saliva drug screen during the Screening Period or on Day 1 of each Treatment Period.
Significant drug sensitivity or a significant allergic reaction to any drug, as well as known hypersensitivity or idiosyncratic reaction to epoetin (or it's excipients, including albumin) or any other related drugs.
A subject who in the Investigator's opinion, has any clinically significant abnormal laboratory evaluations, including Human Immunodeficiency Virus (HIV), Hepatitis B virus surface antigen (HBsAg) and liver function taken at Screening Visit.
Current treatment with long-acting epoetin analogues such as Aranesp.

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
Epoetin HospiraIV dose 3 times a week.	Drug	Arm A: Epoetin Hospira administered IV for three doses
EpogenIV dose 3 times a week	Drug	Arm B: Epogen administered IV for three doses

Primary outcome

Baseline-adjusted area under the serum epoetin concentration curve from the time of dose administration to 48 hours (AUC0-48)
Time frame: On Day 1 and 2 of Pre-Treatment and Treatment Periods 1 and 2 predose (0 hour). On Day 3 of Pre-Treatment Period and Treatment Periods 1 and 2 (i.e., 3rd epoetin dose of the week) at predose (0 hour) and postdose (0.5, 1, 2, 4, 6, 8, 12, 24 and 48 hours)
Maximum serum epoetin concentration (Cmax)
Time frame: On Day 1 and 2 of Pre-Treatment and Treatment Periods 1 and 2 predose (0 hour). On Day 3 of Pre-Treatment Period and Treatment Periods 1 and 2 (i.e., 3rd epoetin dose of the week) at predose (0 hour) and postdose (0.5, 1, 2, 4, 6, 8, 12, 24 and 48 hours)
AUC from time of dose administration to the time of the last measurable concentration (AUC0-t)
Time frame: On Day 1 and 2 of Pre-Treatment and Treatment Periods 1 and 2 predose (0 hour). On Day 3 of Pre-Treatment Period and Treatment Periods 1 and 2 (i.e., 3rd epoetin dose of the week) at predose (0 hour) and postdose (0.5, 1, 2, 4, 6, 8, 12, 24 and 48 hours)
If AUC0-48 cannot be calculated then AUC from time of dose administration to the time of the last measurable concentration (AUC0-t) will be used as the primary measure.

6 secondary outcomes

Dose-adjusted Cmax
Time frame: On Day 1 and 2 of Pre-Treatment and Treatment Periods 1 and 2 predose (0 hour). On Day 3 of Pre-Treatment Period and Treatment Periods 1 and 2 (i.e., 3rd epoetin dose of the week) at predose (0 hour) and postdose (0.5, 1, 2, 4, 6, 8, 12, 24 and 48 hours)
AUC from time of dose administration to the time of the last measurable concentration (AUC0-t)
Time frame: On Day 1 and 2 of Pre-Treatment and Treatment Periods 1 and 2 predose (0 hour). On Day 3 of Pre-Treatment Period and Treatment Periods 1 and 2 (i.e., 3rd epoetin dose of the week) at predose (0 hour) and postdose (0.5, 1, 2, 4, 6, 8, 12, 24 and 48 hours)
Elimination rate Constant (λz)
Time frame: On Day 1 and 2 of Pre-Treatment and Treatment Periods 1 and 2 predose (0 hour). On Day 3 of Pre-Treatment Period and Treatment Periods 1 and 2 (i.e., 3rd epoetin dose of the week) at predose (0 hour) and postdose (0.5, 1, 2, 4, 6, 8, 12, 24 and 48 hours)
Elimination halflife (t1/2)
Time frame: On Day 1 and 2 of Pre-Treatment and Treatment Periods 1 and 2 predose (0 hour). On Day 3 of Pre-Treatment Period and Treatment Periods 1 and 2 (i.e., 3rd epoetin dose of the week) at predose (0 hour) and postdose (0.5, 1, 2, 4, 6, 8, 12, 24 and 48 hours)
Clearance (CL)
Time frame: On Day 1 and 2 of Pre-Treatment and Treatment Periods 1 and 2 predose (0 hour). On Day 3 of Pre-Treatment Period and Treatment Periods 1 and 2 (i.e., 3rd epoetin dose of the week) at predose (0 hour) and postdose (0.5, 1, 2, 4, 6, 8, 12, 24 and 48 hours)
Volume of Distribution (Vd)
Time frame: On Day 1 and 2 of Pre-Treatment and Treatment Periods 1 and 2 predose (0 hour). On Day 3 of Pre-Treatment Period and Treatment Periods 1 and 2 (i.e., 3rd epoetin dose of the week) at predose (0 hour) and postdose (0.5, 1, 2, 4, 6, 8, 12, 24 and 48 hours)

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.

Related trials for Chronic Renal Failure

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases

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.

The record lists no contact. Use the official record to reach the sponsor.

20 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Epoetin Hospira and Epogen in people with Chronic Renal Failure, run by Hospira, now a wholly owned subsidiary of Pfizer at 20 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 14 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 20 sites 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?

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?

Baseline-adjusted area under the serum epoetin concentration curve from the time of dose administration to 48 hours (AUC0-48) (time frame: On Day 1 and 2 of Pre-Treatment and Treatment Periods 1 and 2 predose (0 hour). On Day 3 of Pre-Treatment Period and Treatment Periods 1 and 2 (i.e., 3rd epoetin dose of the week) at predose (0 hour) and postdose (0.5, 1, 2, 4, 6, 8, 12, 24 and 48 hours)). 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 NCT01170078.

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.