HyponatremiaPhase 3SALACIANCT01227512

Effects of Tolvaptan vs Fluid Restriction in Hospitalized Subjects With Dilutional Hyponatremia

A Phase 3 study testing tolvaptan and Fluid Restriction in people with Hyponatremia and Dilutional Hyponatremia, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 56 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Hyponatremia, Dilutional Hyponatremia, Inappropriate ADH Syndrome
What is being tested?: tolvaptan and Fluid Restriction
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 124 participants
Where: 56 sitesUnited States
Study dates: Oct 2010to May 2013
Phase: Phase 3
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Hyponatremia in clinically euvolemic or hypervolemic states, defined as serum sodium < 130 mEq/L prior to randomization
Clinically significant symptoms of hyponatremia, defined as a CGI-S score between 3-6, inclusive
Female subjects of child bearing potential who agree to remain abstinent or to practice double-barrier forms of birth control from screening through 30 days following first dose on IMP

Who cannot join

Women who are pregnant or breast feeding, and females of childbearing potential who are not using acceptable contraceptive methods (such as barrier contraceptives or methods that result in a failure rate of less than 1%)
Hyponatremia in hypovolemic states, defined as the presence of clinical and historical evidence of extracellular fluid volume depletion, including but not limited to skin turgor, orthostatic changes in blood pressure or heart rate, dry mucous membranes, or a response to IV saline challenge
Subjects who are likely to require prolonged hospitalization for reasons other than hyponatremia, eg. new femoral fracture, surgeries requiring extended recovery
Recent prior treatment for hyponatremia: hypertonic saline (including normal saline challenge) (within 8 hours of baseline) or urea, lithium, demeclocycline, conivaptan or tolvaptan (within 4 days of baseline). Includes any treatment, other than fluid restriction for the purpose of increasing serum sodium.
Hyponatremia symptoms of a severity (eg, CGI = 7) such that they require immediate intervention with hypertonic saline; or are expected to require such therapy within 48 hours
Causes of neurological symptoms which are attributable to psychological (psychosis), structural (dementia of the Alzheimer's type, stroke, transient ischemic attack, multi-infarct dementia) or other metabolic causes (eg. hyper- or hypo-: oxemia, glycemia, calcemia, ammonemia, etc)

Show all 21Show fewer

Acute and transient hyponatremia associated with head trauma or severe neurological injury (eg. stroke, subdural hematoma)or the use of recreational drugs.
History of hyponatremia known to be due to severe, untreated hypothyroidism/adrenal insufficiency
Subjects with psychogenic polydipsia
Systolic arterial blood pressure < 90 mmHg at screening
History of hypersensitivity and/or idiosyncratic reaction to benzazepine or benzazepine derivatives (such as benazepril), or tolvaptan
History of drug or medication abuse within the 3 months prior to screening, or current alcohol abuse
Uncontrolled diabetes mellitus defined as glucose > 300 mg/dL [16.7 mmol/L]
Current urinary tract obstruction (eg, obstructive benign prostatic hypertrophy)
Current condition of anuria
Serum creatinine > 3.5 mg/dL at screening
Terminally ill or moribund condition with little chance of short-term (eg, 30 day) survival
Subjects whose hyponatremia is the result of any medication that can safely be withdrawn (examples of drugs often not withdrawn include: anticonvulsants [eg, carbamazepine] and antipsychotics [eg, haloperidol])
Patients receiving DDAVP within 2 days of screening
Patients with history of active variceal bleeding within the past 30 days, without prior approval from sponsor medical monitor
Participation in another investigational drug trial within the past 30 days

Trial locations and contacts

56 sites in 1 country.

City, postcode or hospital

56 sites in 1 country

United States56 sites

Otsuka Investigational Site
Azusa, California, 91702
Otsuka Investigational Site
Baltimore, Maryland, 21215
Otsuka Investigational Site
Banning, California, 92220
Otsuka Investigational Site
Bethleham, Pennsylvania, 18017
Otsuka Investigational Site
Birmingham, Alabama, 35216
Otsuka Investigational Site
Birmingham, Alabama, 35242
Otsuka Investigational Site
Buffalo, New York, 14203
Otsuka Investigational Site
Buffalo, New York, 14215
Otsuka Investigational Site
Cincinnati, Ohio, 45267
Otsuka Investigational Site
Cleveland, Ohio, 44195
Otsuka Investigational Site
Columbus, Ohio, 43212
Otsuka Investigational Site
Culver City, California, 90232
Otsuka Investigational Site
Denver, Colorado, 80210
Otsuka Investigational Site
Elizabethtown, Kentucky, 42701
Otsuka Investigational Site
Fairfax, Virginia, 22030
Otsuka Investigational Site
Fairfield, Ohio, 45014
Otsuka Investigational Site
Fountain Valley, California, 92708
Otsuka Investigational Site
Galveston, Texas, 77555
Otsuka Investigational Site
Grand Island, Nebraska, 68803
Otsuka Investigational Site
Haddon Heights, New Jersey, 08035
Otsuka Investigational Site
Houston, Texas, 77030
Otsuka Investigational Site
Jackson, Mississippi, 39216
Otsuka Investigational Site
Jacksonville, Florida, 32207
Otsuka Investigational Site
Jacksonville, Florida, 32209
Otsuka Investigational Site
Jacksonville, Florida, 32216
Otsuka Investigational Site
Jamaica, New York, 11418
Otsuka Investigational Site
Los Angeles, California, 90025
Otsuka Investigational Site
Los Angeles, California, 90033
Otsuka Investigational Site
Madison, Wisconsin, 53705
Otsuka Investigational Site
Minneapolis, Minnesota, 55455
Otsuka Investigational Site
Mission, Texas, 78572
Otsuka Investigational Site
Mobile, Alabama, 36608
Otsuka Investigational Site
New York, New York, 10032
Otsuka Investigational Site
Newark, New Jersey, 07103
Otsuka Investigational Site
Northridge, California, 91324
Otsuka Investigational Site
Oklahoma City, Oklahoma, 73120
Otsuka Investigational Site
Omaha, Nebraska, 68131
Otuska Investigational Site
Orange, California, 92868
Otsuka Investigational Site
Orlando, Florida, 32803
Otsuka Investigational Site
Philadelphia, Pennsylvania, 19102
Otsuka Investigational Site
Philadelphia, Pennsylvania, 19140
Otsuka Investigational Site
Port Charlotte, Florida, 33952
Otsuka Investigational Site
Providence, Rhode Island, 02903
Otsuka Investigational Site
Rochester, Minnesota, 55905
Otsuka Investigational Site
Saginaw, Michigan, 48602
Otsuka Investigational Site
San Antonio, Texas, 78205
Otsuka Investigational Site
San Antonio, Texas, 78229
Otsuka Investigational Site
Savannah, Georgia, 31405
Otsuka Investigational Site
Southfield, Michigan, 48075
Otsuka Investigational Site
Springfield, Massachusetts, 01107
Otsuka Investigational Site
St Louis, Missouri, 63110
Otsuka Investigational Site
The Bronx, New York, 10461
Otsuka Investigational Site
Toledo, Ohio, 43560
Otsuka Investigational Site
Washington D.C., District of Columbia, 20010
Otsuka Investigational Site
West Reading, Pennsylvania, 19611
Otsuka Investigational Site
Yorba Linda, California, 92886

Other trials in United States

About this study

Official title: Phase 3b, Multicenter, Randomized, Single-blind, Parallel Group Trial of the Effects of Titrated Oral SAMSCA(r) (Tolvaptan) 15, 30, or 60 mg QD Compared to Placebo Plus Fluid Restriction on Length of Hospital Stay and Symptoms in Subjects Hospitalized With Dilutional Hyponatremia

The purpose of this study is to determine if hospitalized patients with symptomatic hyponatremia treated with tolvaptan are in the hospital for less time than patients treated with fluid restriction. The study will also test if tolvaptan is better than fluid restriction in treating the symptoms of hyponatremia in hospitalized patients.

Conditions: Hyponatremia, Dilutional Hyponatremia, Inappropriate ADH Syndrome
Being tested: tolvaptan, Fluid Restriction
Keywords: Hyponatremia, Dilutional Hyponatremia, Euvolemic Hyponatremia, Hypervolemic Hyponatremia, Fluid Restriction, Tolvaptan
Medical subject headings: Hyponatremia, Inappropriate ADH Syndrome

What participants receive

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

tolvaptanDrug
Also called SAMSCA, OPC-41061, OPC-156
15 mg titrated to 30 mg then 60 mg once daily as oral tablet for up to 7 days based on response.
Fluid RestrictionOther
Placebo tablet once daily with prescribed daily fluid intake of 1500 mL, then intensifying to 2 lower volumes of fluid intake for up to 7 days based on response.
Since all particpants were blinded to treatment, titration to stricter fluid restriction followed the same algorithm as tolvaptan, increasing both the level of fluid restriction and increasing the placebo "dose"

Study groups in NCT01227512
Study group	Role	What they receive
Tolvaptan 15-60mg	Experimental	Oral tablet without fluid restriction. After the initial dose, daily dose may be titrated based on response. Receives: Drug: tolvaptan
Fluid Restriction	Active comparator	Placebo tablet with prescribed fluid restriction. After the initial dose, level of fluid restriction may titrated based response. Receives: Other: Fluid Restriction

What is being measured

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

Length of Hospital Stay (LoS)
LoS was time to clinically ready to be hospital discharged (CRBD) from study treatment initiation, disregarding prolonged hospitalization due solely to social factors.
Measured: 45 days

Secondary outcomes (7)

Change From Baseline to 48 Hour Post Dose in Clinical Global Impression-Severity (CGI-S) of Hyponatremia Symptoms.
Change from baseline in blinded rater assessed CGI-S at 48 hours post-first dose or at discharge/rescue therapy, if earlier was assessed.
The CGI-S is a one-question rating scale which was as follows: "Considering your total clinical experience with hyponatremia symptoms in this particular population, how symptomatic is the patient at this time?" 0=not assessed; 1=normal, not at all symtpmatic; 2=borderline symptomatic; 3=mildly symptomatic; 4=moderately symptomatic; 5=markedly symptomatic; 6=severely symptomatic; 7=among the most severly symptomatic patients.
Measured: Baseline to 48 hours post dose
Change From Baseline to 24 and 72 Hours Post Dose in CGI-S of Hyponatremia Symptoms.
Change in CGI-S of hyponatremia symptoms from pretreatment baseline at 24 and 72 hours post-first dose, or at discharge/rescue therapy if earlier was assessed.
The CGI-S is a one-question rating scale which was as follows: "Considering your total clinical experience with hyponatremia symptoms in this particular population, how symptomatic is the patient at this time?" 0=not assessed; 1=normal, not at all symtpmatic; 2=borderline symptomatic; 3=mildly symptomatic; 4=moderately symptomatic; 5=markedly symptomatic; 6=severely symptomatic; 7=among the most severly symptomatic patients.
Measured: Baseline to 24 and 72 hours post dose
Change From Baseline to 48 Hours Post Dose in Clinical Global Impression - Improvement (CGI-I) Score of Hyponatremia Symptoms.
Change in CGI-I score at 48 hours post-first dose or discharge/rescue therapy, if earlier was assessed.
The CGI-I is a one-question rating scale where the participant is asked to rate total improvement whether or not, in their judgment, it is due entirely to trial treatment. Compared to his/her condition at admission to the trial, how much has he/she changed? 0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse
Measured: Baseline to 48 hours post dose
Change From Baseline in Serum Sodium Concentration (24 Hour Area Under the Curve [AUC]).
Average 24 hour AUC of serum sodium concentration change from baseline, from Day 1 Hour 0 up to 72 hours post-first dose was assessed.
A serum sodium sample was drawn at pre-treament and 8, 24, 48, and 72 hours post-first dose. Serum sodium was also assessed between 36 and 72 hours after the last dose.
Analysis of AUC was for daily average AUC, hence the units or AUC are mEq/L/24 hours.
Measured: 0 to 72 hours
Time to First 2-point Improvement in CGI-S Score.
CGI-S data up to 72 hours were used to identify 2-point improvements. Please refer to outcome measure 2 for details on the scale. For the analysis of time to first 2-point improvement in CGI-S, CGI-S data up to Hour 72 were used to identify 2-point improvements. Data for participants who received rescue therapy were censored at the time of receiving rescue therapy. For participants who were discharged before Hour 72 without reaching 2-point improvement in CGI-S, data were censored at the time of discharge. Other participants who did not reach the 2-point improvement during the 72 hours also had their data censored at their last CGI-S observations within 72 hours.
Measured: Up to 72 hours
Percentage of Participants With Clinical Global Impression-Improvement (CGI-I) Score Improved to a Score of 1 or 2.
Percentage of responders (defined as CGI-I score of 1 = very much improved or 2 = much improved) at 48 hours post-first dose, or at discharge/rescue therapy, if earlier. Participants given rescue therapy were given a score of 7.
Measured: 48 hours post dose
Percentage of Participants Requiring Rescue Therapy for Hyponatremia
Percentage of participants requiring rescue therapy within first 7 days of treatment for hyponatremia.
Measured: 7 days

Timeline

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

Oct 2010May 2013

First posted25 Oct 2010 (estimated)
Study startOct 2010
Primary completionMay 2013
Study completionMay 2013

Why it stopped: Recruitment challenges and results of interim futility analysis, which showed less than likely to achieve primary endpoint goal-length of hospital stay.

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 HyponatremiaStudies of the same condition, open and under way.
More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 124 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01227512
Sponsor's protocol ID: 156-08-275
Acronym: SALACIA
Status last verified: Oct 2014
First submitted: 22 Oct 2010
Last updated: 30 Oct 2014
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

RecruitingPhase 3
Systematic Use of DDAVP to Prevent Serum Sodium Overcorrection in Severe Hyponatremia
Hyponatremia
Enrolling by invitationObservational study
International Multi-center Retrospective Study of Patients With Serum Sodium ≤110 mmol/L to Determine the Relationship Between Osmotic Demyelination Syndrome (ODS) and Rapid Correction of Hyponatremia
Hyponatremia Symptomatic, Osmotic Demyelination Syndrome
Active, not recruitingObservational study
Samsca Post-marketing General Drug Use-results Survey in Patients With Hyponatremia in SIADH
Antidiuretic Hormone, Inappropriate Secretion
Recruiting
Urea for Treatment of Hyponatremia in Patients With SIAD Unresponsive to Fluid Restriction
SIAD - Syndrome of Inappropriate Antidiuresis
Active, not recruitingObservational study
Hyponatremia - Complications, Prognosis, Epidemiology in Finnish Tertiary Care
Hyponatremia, Osmotic Demyelination Syndrome

All Hyponatremia trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 3b, Multicenter, Randomized, Single-blind, Parallel Group Trial of the Effects of Titrated Oral SAMSCA(r) (Tolvaptan) 15, 30, or 60 mg QD Compared to Placebo Plus Fluid Restriction on Length of Hospital Stay and Symptoms in Subjects Hospitalized With Dilutional Hyponatremia
ClinicalTrials.gov ID: NCT01227512
Acronym / sponsor ID: SALACIA / 156-08-275
Conditions: Hyponatremia, Dilutional Hyponatremia, Inappropriate ADH Syndrome
Keywords: Hyponatremia, Dilutional Hyponatremia, Euvolemic Hyponatremia, Hypervolemic Hyponatremia, Fluid Restriction, Tolvaptan
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Recruitment challenges and results of interim futility analysis, which showed less than likely to achieve primary endpoint goal-length of hospital stay.
Enrolment: 124 participants (actual)
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
Study start: Oct 2010
Primary completion: May 2013 (actual)
Study completion: May 2013 (actual)
First posted: 25 Oct 2010 (estimated)
Results: Posted 17 Oct 2014

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Tolvaptan 15-60mg	Experimental	Drug: tolvaptanOral tablet without fluid restriction. After the initial dose, daily dose may be titrated based on response.
Fluid Restriction	Active comparator	Other: Fluid RestrictionPlacebo tablet with prescribed fluid restriction. After the initial dose, level of fluid restriction may titrated based response.

Who may qualify

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

Key inclusion criteria (3 listed)

Hyponatremia in clinically euvolemic or hypervolemic states, defined as serum sodium < 130 mEq/L prior to randomization
Clinically significant symptoms of hyponatremia, defined as a CGI-S score between 3-6, inclusive
Female subjects of child bearing potential who agree to remain abstinent or to practice double-barrier forms of birth control from screening through 30 days following first dose on IMP

Key exclusion criteria (21 listed)

Women who are pregnant or breast feeding, and females of childbearing potential who are not using acceptable contraceptive methods (such as barrier contraceptives or methods that result in a failure rate of less than 1%)
Hyponatremia in hypovolemic states, defined as the presence of clinical and historical evidence of extracellular fluid volume depletion, including but not limited to skin turgor, orthostatic changes in blood pressure or heart rate, dry mucous membranes, or a response to IV saline challenge
Subjects who are likely to require prolonged hospitalization for reasons other than hyponatremia, eg. new femoral fracture, surgeries requiring extended recovery
Recent prior treatment for hyponatremia: hypertonic saline (including normal saline challenge) (within 8 hours of baseline) or urea, lithium, demeclocycline, conivaptan or tolvaptan (within 4 days of baseline). Includes any treatment, other than fluid restriction for the purpose of increasing serum sodium.
Hyponatremia symptoms of a severity (eg, CGI = 7) such that they require immediate intervention with hypertonic saline; or are expected to require such therapy within 48 hours

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
tolvaptanAlso: SAMSCA, OPC-41061, OPC-15615 mg titrated to 30 mg then 60 mg once daily as oral tablet for up to 7 days based on response.	Drug	Tolvaptan 15-60mg
Fluid RestrictionPlacebo tablet once daily with prescribed daily fluid intake of 1500 mL, then intensifying to 2 lower volumes of fluid intake for up to 7 days based on response. Since all particpants were blinded to treatment, titration to stricter fluid restriction followed the same algorithm as tolvaptan, increasing both the level of fluid restriction and increasing the placebo "dose"	Other	Fluid Restriction

Primary outcome

Length of Hospital Stay (LoS)
Time frame: 45 days
LoS was time to clinically ready to be hospital discharged (CRBD) from study treatment initiation, disregarding prolonged hospitalization due solely to social factors.

7 secondary outcomes

Change From Baseline to 48 Hour Post Dose in Clinical Global Impression-Severity (CGI-S) of Hyponatremia Symptoms.
Time frame: Baseline to 48 hours post dose
Change From Baseline to 24 and 72 Hours Post Dose in CGI-S of Hyponatremia Symptoms.
Time frame: Baseline to 24 and 72 hours post dose
Change From Baseline to 48 Hours Post Dose in Clinical Global Impression - Improvement (CGI-I) Score of Hyponatremia Symptoms.
Time frame: Baseline to 48 hours post dose
Change From Baseline in Serum Sodium Concentration (24 Hour Area Under the Curve [AUC]).
Time frame: 0 to 72 hours
Time to First 2-point Improvement in CGI-S Score.
Time frame: Up to 72 hours
Percentage of Participants With Clinical Global Impression-Improvement (CGI-I) Score Improved to a Score of 1 or 2.
Time frame: 48 hours post dose
Percentage of Participants Requiring Rescue Therapy for Hyponatremia
Time frame: 7 days

Results and safety

Results posted to the registry on 17 Oct 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tolvaptan 15-60 mg/Day	66	53
Placebo	58	48

Primary outcome: Length of Hospital Stay (LoS)

Time frame: 45 days. Median (95% Confidence Interval). Unit: Days

Measure	Tolvaptan 15-60mg/Day n = 66	Placebo n = 55
Value	3.5 (3.0 to 4.5)	4.0 (3.5 to 5.0)

Tolvaptan 15-60mg/Day vs Placebo: p = 0.9495, Generalized Wilcoxon Test

Population analysed: Analysis was performed on the modified intent-to-treat population (MITT) which included all randomized participants who received at least one dose of study drug regardless of any protocol violation.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were recorded from the time the Informed Consent Form was signed up to 45 days after study drug administration.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tolvaptan 15-60 mg/Day	18 of 66 (27.3%)	52 of 66 (78.8%)	Not reported
Placebo	9 of 55 (16.4%)	43 of 55 (78.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hyponatremia

RecruitingPhase 3
Systematic Use of DDAVP to Prevent Serum Sodium Overcorrection in Severe Hyponatremia
Hyponatremia
Enrolling by invitationObservational study
International Multi-center Retrospective Study of Patients With Serum Sodium ≤110 mmol/L to Determine the Relationship Between Osmotic Demyelination Syndrome (ODS) and Rapid Correction of Hyponatremia
Hyponatremia Symptomatic, Osmotic Demyelination Syndrome
Active, not recruitingObservational study
Samsca Post-marketing General Drug Use-results Survey in Patients With Hyponatremia in SIADH
Antidiuretic Hormone, Inappropriate Secretion
Recruiting
Urea for Treatment of Hyponatremia in Patients With SIAD Unresponsive to Fluid Restriction
SIAD - Syndrome of Inappropriate Antidiuresis
Active, not recruitingObservational study
Hyponatremia - Complications, Prognosis, Epidemiology in Finnish Tertiary Care
Hyponatremia, Osmotic Demyelination Syndrome

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.

Ann Dandurand, MD study director

Otsuka Pharmaceutical Development & Commercialization, Inc.

56 sites 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 3 inclusion and 21 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: stopped early, as of the sponsor's last update on 30 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 17 Oct 2014). 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?

Length of Hospital Stay (LoS) (time frame: 45 days). 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 NCT01227512.

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 30 Oct 2014.