AzTrials
AzTrials

Chronic Idiopathic ConstipationPhase 3NCT01919697

Open-label Extension (OLE) Study of Plecanatide for Chronic Idiopathic Constipation (CIC)

A Phase 3 study testing Plecanatide in people with Chronic Idiopathic Constipation, run by Bausch Health Americas, Inc. at 220 sites in 2 countries.

Completed

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

Official record
Search all trials

Trial summary

This is a multi-center, open-label, 52-week safety and tolerability study of plecanatide in patients with Chronic Idiopathic Constipation (CIC). Read more about this study

Who is it for?
Ages 18 to 81 years
Conditions the study is for
Chronic Idiopathic Constipation
What is being tested?
Plecanatide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,370 participants
Where
220 sitesin 2 countries
Study dates
Aug 2013to Mar 2016
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 to 81 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient completed a previous double-blind plecanatide study and was compliant with the study requirements.
  • Patient is in good health without unstable acute illness or exacerbation of an unstable chronic illness or chronic disease that may affect study assessments, particularly if there has been a significant change to health status since the previous plecanatide study.

Who cannot join

  • Patient has had major surgery including laparoscopic procedures requiring general anesthesia within 60 days of Day 1.
  • Patient has a medical history of hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection.
  • Patient has taken a protocol-prohibited drug without the appropriate washout period.

Trial locations and contacts

220 sites in 2 countries.

220 sites in 2 countries

United States211 sites

  • Synergy Research Site

    Albuquerque, New Mexico, 87108

  • Synergy Research Site

    Albuquerque, New Mexico, 87109

  • Synergy Research Site

    Anaheim, California, 92801

  • Synergy Research Site

    Anaheim, California, 92804

  • Synergy Research Site

    Anderson, South Carolina, 29621

  • Synergy Research Site

    Arlington, Texas, 76012

  • Synergy Research Site

    Artesia, California, 90701

  • Synergy Research Site

    Athens, Georgia, 30606

  • Synergy Research Site

    Atlanta, Georgia, 30342

  • Synergy Research Site

    Augusta, Kansas, 67010

  • Synergy Research Site

    Austin, Texas, 78731

  • Synergy Research Site

    Austin, Texas, 78745

  • Synergy Research Site

    Bastrop, Louisiana, 71220

  • Synergy Research Site

    Beavercreek, Ohio, 45432

  • Synergy Research Site

    Biloxi, Mississippi, 39531

  • Synergy Research Site

    Birmingham, Alabama, 35242

  • Synergy Research Site

    Blackfoot, Idaho, 83221

  • Synergy Research Site

    Boston, Massachusetts, 02131

  • Synergy Research Site

    Boynton Beach, Florida, 33426

  • Synergy Research Site

    Brandon, Florida, 33511

  • Synergy Research Site

    Bristol, Connecticut, 06010

  • Synergy Research Site

    Brooklyn, New York, 11206

  • Synergy Research Site

    Brownsburg, Indiana, 46112

  • Synergy Research Site

    Carlsbad, California, 92008

  • Synergy Research Site

    Cary, North Carolina, 27518

  • Synergy Research Site

    Centerville, Ohio, 45459

  • Synergy Research Site

    Cerritos, California, 90703

  • Synergy Research Site

    Chandler, Arizona, 85224

  • Synergy Research Site

    Channelview, Texas, 77530

  • Synergy Research Site

    Chapel Hill, North Carolina, 27599

  • Synergy Research Site

    Charleston, South Carolina, 29406

  • Synergy Research Site

    Charlotte, North Carolina, 28210

  • Synergy Research Site

    Charlotte, North Carolina, 28277

  • Synergy Research Site

    Chattanooga, Tennessee, 37421

  • Synergy Research Site

    Chesterfield, Michigan, 48047

  • Synergy Research Site

    Chevy Chase, Maryland, 20815

  • Synergy Research Site

    Chicago, Illinois, 60602

  • Synergy Research Site

    Christiansburg, Virginia, 24073

  • Synergy Research Site

    Chula Vista, California, 91910

  • Synergy Research Site

    Cincinnati, Ohio, 45224

  • Synergy Research Site

    Cincinnati, Ohio, 45246

  • Synergy Research Site

    Clearwater, Florida, 33756

  • Synergy Research Site

    Clearwater, Florida, 33759

  • Synergy Research Site

    Cleveland, Ohio, 44122

  • Synergy Research Site

    Clive, Iowa, 50325

  • Synergy Research Site

    Colorado Springs, Colorado, 80904

  • Synergy Research Site

    Colorado Springs, Colorado, 80907

  • Synergy Research Site

    Colorado Springs, Colorado, 80909

  • Synergy Research Site

    Columbia, South Carolina, 29203

  • Synergy Research Site

    Corona, California, 92879

  • Synergy Research Site

    Cutler Bay, Florida, 33189

  • Synergy Research Site

    Dallas, Texas, 75230

  • Synergy Research Site

    Dallas, Texas, 75234

  • Synergy Research Site

    Decatur, Georgia, 30032

  • Synergy Research Site

    Decatur, Georgia, 30033

  • Synergy Research Site

    DeLand, Florida, 32720

  • Synergy Research Site

    Denver, Colorado, 80218

  • Synergy Research Site

    Denver, Colorado, 80220

  • Synergy Research Site

    Denver, Colorado, 80246

  • Synergy Research Site

    Dothan, Alabama, 36305

  • Synergy Research Site

    Elizabeth, New Jersey, 07202

  • Synergy Research Site

    Encinitas, California, 92024

  • Synergy Research Site

    Fargo, North Dakota, 58103

  • Synergy Research Site

    Flint, Michigan, 48504

  • Synergy Research Site

    Fort Lauderdale, Florida, 33306

  • Synergy Research Site

    Fountain Valley, California, 92708

  • Synergy Research Site

    Franklin, Tennessee, 37064

  • Synergy Research Site

    Fresno, California, 93726

  • Synergy Research Site

    Grand Island, Nebraska, 68803

  • Synergy Research Site

    Great Neck, New York, 11023

  • Synergy Research Site

    Greensboro, North Carolina, 27403

  • Synergy Research Site

    Gulf Shores, Alabama, 36542

  • Synergy Research Site

    Hawaiian Gardens, California, 90716

  • Synergy Research Site

    Henderson, Nevada, 89014

  • Synergy Research Site

    Henrico, Virginia, 23233

  • Synergy Research Site

    Hialeah, Florida, 33012

  • Synergy Research Site

    Hialeah, Florida, 33013

  • Synergy Research Site

    Hialeah, Florida, 33016

  • Synergy Research Site

    Homestead, Florida, 33030

  • Synergy Research Site

    Houston, Texas, 77034

  • Synergy Research Site

    Houston, Texas, 77043

  • Synergy Research Site

    Houston, Texas, 77062

  • Synergy Research Site

    Houston, Texas, 77070

  • Synergy Research Site

    Houston, Texas, 77090

  • Synergy Research Site

    Houston, Texas, 77099

  • Synergy Research Site

    Huber Heights, Ohio, 45424

  • Synergy Research Site

    Humble, Texas, 77338

  • Synergy Research Site

    Huntsville, Alabama, 35801

  • Synergy Research Site

    Jackson, Mississippi, 39202

  • Synergy Research Site

    Jackson, Tennessee, 38305

  • Synergy Research Site

    Jupiter, Florida, 33458

  • Synergy Research Site

    Katy, Texas, 77450

  • Synergy Research Site

    Kinston, North Carolina, 28501

  • Synergy Research Site

    Knoxville, Tennessee, 37912

  • Synergy Research Site

    La Mirada, California, 90638

  • Synergy Research Site

    Laguna Hills, California, 92653

  • Synergy Research Site

    Lakeland, Florida, 33805

  • Synergy Research Site

    Lancaster, California, 93534

  • Synergy Research Site

    Las Vegas, Nevada, 89103

  • Synergy Research Site

    Las Vegas, Nevada, 89119

  • Synergy Research Site

    Las Vegas, Nevada, 89121

  • Synergy Research Site

    Levittown, Pennsylvania, 19056

  • Synergy Research Site

    Lexington, Kentucky, 40503

  • Synergy Research Site

    Limerick, Pennsylvania, 19468

  • Synergy Research Site

    Little Rock, Arkansas, 72211

  • Synergy Research Site

    Littleton, Colorado, 80128

  • Synergy Research Site

    Lodi, New Jersey, 07644

  • Synergy Research Site

    Logan, Utah, 84341

  • Synergy Research Site

    Long Beach, California, 90806

  • Synergy Research Site

    Los Angeles, California, 90015

  • Synergy Research Site

    Los Angeles, California, 90045

  • Synergy Research Site

    Lynchburg, Virginia, 24502

  • Synergy Research Site

    Marlton, New Jersey, 08053

  • Synergy Research Site

    Marrero, Louisiana, 70072

  • Synergy Research Site

    Maumee, Ohio, 43537

  • Synergy Research Site

    Memphis, Tennessee, 38119

  • Synergy Research Site

    Mentor, Ohio, 44060

  • Synergy Research Site

    Metairie, Louisiana, 70006

  • Synergy Research Site

    Miami, Florida, 33015

  • Synergy Research Site

    Miami, Florida, 33032

  • Synergy Research Site

    Miami, Florida, 33122

  • Synergy Research Site

    Miami, Florida, 33125

  • Synergy Research Site

    Miami, Florida, 33126

  • Synergy Research Site

    Miami, Florida, 33130

  • Synergy Research Site

    Miami, Florida, 33142

  • Synergy Research Site

    Miami, Florida, 33144

  • Synergy Research Site

    Miami, Florida, 33155

  • Synergy Research Site

    Miami, Florida, 33165

  • Synergy Research Site

    Miami, Florida, 33173

  • Synergy Research Site

    Miami, Florida, 33174

  • Synergy Research Site

    Miami, Florida, 33175

  • Synergy Research Site

    Miami, Florida, 33176

  • Synergy Research Site

    Miami, Florida, 33186

  • Synergy Research Site

    Miami Lakes, Florida, 33016

  • Synergy Research Site

    Miami Springs, Florida, 33166

  • Synergy Research Site

    Mission Hills, California, 91345

  • Synergy Research Site

    Nashville, Tennessee, 37211

  • Synergy Research Site

    New Bedford, Massachusetts, 02740

  • Synergy Research Site

    New Orleans, Louisiana, 70115

  • Synergy Research Site

    New Orleans, Louisiana, 70119

  • Synergy Research Site

    New Tazewell, Tennessee, 37825

  • Synergy Research Site

    New York, New York, 10016

  • Synergy Research Site

    Newport News, Virginia, 23606

  • Synergy Research Site

    Newton, Kansas, 67114

  • Synergy Research Site

    Norfolk, Virginia, 23502

  • Synergy Research Site

    Norfolk, Virginia, 23507

  • Synergy Research Site

    Norman, Oklahoma, 73071

  • Synergy Research Site

    North Hollywood, California, 91606

  • Synergy Research Site

    North Little Rock, Arkansas, 72117

  • Synergy Research Site

    Oakwood, Georgia, 30566

  • Synergy Research Site

    Oakwood, Ohio, 45419

  • Synergy Research Site

    Oklahoma City, Oklahoma, 73102

  • Synergy Research Site

    Oklahoma City, Oklahoma, 73104

  • Synergy Research Site

    Omaha, Nebraska, 68114

  • Synergy Research Site

    Orange, California, 92868

  • Synergy Research Site

    Orlando, Florida, 32801

  • Synergy Research Site

    Orlando, Florida, 32806

  • Synergy Research Site

    Orlando, Florida, 32807

  • Synergy Research Site

    Owensboro, Kentucky, 42303

  • Synergy Research Site

    Pasadena, California, 91105

  • Synergy Research Site

    Pembroke Pines, Florida, 33026

  • Synergy Research Site

    Philadelphia, Pennsylvania, 19152

  • Synergy Research Site

    Phoenix, Arizona, 85018

  • Synergy Research Site

    Pittsburgh, Pennsylvania, 15206

  • Synergy Research Site

    Plano, Texas, 75093

  • Synergy Research Site

    Port Orange, Florida, 32129

  • Synergy Research Site

    Poughkeepsie, New York, 12601

  • Synergy Research Site

    Raleigh, North Carolina, 27612

  • Synergy Research Site

    Reno, Nevada, 89511

  • Synergy Research Site

    Richland, Washington, 99352

  • Synergy Research Site

    Richmond, Virginia, 23294

  • Synergy Research Site

    Rochester, Michigan, 48307

  • Synergy Research Site

    Sacramento, California, 95821

  • Synergy Research Site

    Saginaw, Michigan, 48604

  • Synergy Research Site

    Salt Lake City, Utah, 84124

  • Synergy Research Site

    San Antonio, Texas, 78209

  • Synergy Research Site

    San Antonio, Texas, 78215

  • Synergy Research Site

    San Diego, California, 92103

  • Synergy Research Site

    San Diego, California, 92108

  • Synergy Research Site

    San Diego, California, 92114

  • Synergy Research Site

    Sandy Springs, Georgia, 30328

  • Synergy Research Site

    Savannah, Georgia, 31406

  • Synergy Research Site

    Seattle, Washington, 98105

  • Synergy Research Site

    Shawnee Mission, Kansas, 66218

  • Synergy Research Site

    Shreveport, Louisiana, 71103

  • Synergy Research Site

    Smyrna, Georgia, 30082

  • Synergy Research Site

    Snellville, Georgia, 30078

  • Synergy Research Site

    Southfield, Michigan, 48034

  • Synergy Research Site

    St Louis, Missouri, 63128

  • Synergy Research Site

    St. George, Utah, 84790

  • Synergy Research Site

    St. Petersburg, Florida, 33709

  • Synergy Research Site

    Stow, Ohio, 44224

  • Synergy Research Site

    Sugar Land, Texas, 77479

  • Synergy Research Site

    Tacoma, Washington, 98405

  • Synergy Research Site

    Tamarac, Florida, 33319

  • Synergy Research Site

    Tampa, Florida, 33606

  • Synergy Research Site

    Tampa, Florida, 33607

  • Synergy Research Site

    Tempe, Arizona, 85283

  • Synergy Research Site

    Thousand Oaks, California, 91360

  • Synergy Research Site

    Tucson, Arizona, 85704

  • Synergy Research Site

    Tucson, Arizona, 85712

  • Synergy Research Site

    Tucson, Arizona, 85716

  • Synergy Research Site

    Waterbury, Connecticut, 06708

  • Synergy Research Site

    Wauwatosa, Wisconsin, 53226

  • Synergy Research Site

    West Jordan, Utah, 84088

  • Synergy Research Site

    West Palm Beach, Florida, 33409

  • Synergy Research Site

    Wichita, Kansas, 67205

  • Synergy Research Site

    Wichita, Kansas, 67207

  • Synergy Research Site

    Wilmington, North Carolina, 28401

  • Synergy Research Site

    Winston-Salem, North Carolina, 27103

  • Synergy Research Site

    Yardley, Pennsylvania, 19067

Other trials in United States

Canada9 sites

  • Synergy Research Site

    Bridgewater, Nova Scotia, B4V 3N2

  • Synergy Research Site

    Cambridge, Ontario, N1S 2M6

  • Synergy Research Site

    Greater Sudbury, Ontario, P3A 1Y8

  • Synergy Research Site

    Kelowna, British Columbia, V1Y 1Z9

  • Synergy Research Site

    Mirabel, Quebec, J7J 2K8

  • Synergy Research Site

    Pointe-Claire, Quebec, H9R 4S3

  • Synergy Research Site

    Saint Romuald, Quebec, G6W 5M6

  • Synergy Research Site

    Toronto, Ontario, M3J 2C5

  • Synergy Research Site

    Toronto, Ontario, M9W 4L6

Other trials in Canada

About this study

Official title: An Open-Label Extension (OLE), Long-term Safety and Tolerability Study of Plecanatide in Patients With Chronic Idiopathic Constipation (CIC)

This is a multi-center, open-label, 52-week safety and tolerability study of plecanatide in patients with Chronic Idiopathic Constipation (CIC).

Read the detailed description

This is an open-label extension study of plecanatide in the treatment of patients with CIC who previously completed Synergy Protocols SP304-20210 and SP304203-00 (The CIC3 Study).

The planned duration of each patient's study participation is up to 411 days, including up to 33 days of screening, 8 study visits over 52 weeks of treatment and a follow-up visit 2 weeks after the last dose of study drug.

Being tested
Plecanatide
Keywords
Plecantaide, Chronic Idiopathic Constipation, Chronic, Idiopathic, Constipation, Synergy, CIC, CIC study, CIC OLE, CIC OLE study, OLE, OLE CIC, OLE CIC3, Open label, Open label study, Long term, Long term study, Extension, Extension study
Medical subject headings
Bronchiolitis Obliterans Syndrome, Constipation

What participants receive

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

  • PlecanatideDrug

Study groups in NCT01919697
Study groupRoleWhat they receive
Plecanatide 3.0 mgExperimentalPlecanatide 3.0 mg, one tablet by mouth daily for 52 weeks
Receives: Drug: Plecanatide
Plecanatide 6.0 mgExperimentalPlecanatide 6.0 mg, one tablet by mouth daily for 52 weeks
Receives: Drug: Plecanatide

What is being measured

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

  1. Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE)

    All clinically significant findings upon Physical Examinations of the Safety Population during the treatment period were reported as TEAEs. Safety was evaluated based on number of patients who experienced at least one TEAE.

    Measured: From first dose up to 72 weeks

  2. Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE) Leading to Discontinuation of Plecanatide

    Tolerability was evaluated based on number of patients who experienced at least one TEAE leading to discontinuation of the study drug

    Measured: From first dose up to 72 weeks

  3. Summary of Vital Signs at >Day 364 - Blood Pressure (Systolic and Diastolic; mmHg)

    The vital signs included in the assessments were blood pressure (systolic and diastolic; mmHg), heart rate (beats per minute), body temperature (°C) and respiration rate (breaths per minute).

    Measured: From first dose up to 72 weeks

  4. Summary of Vital Signs at >Day 364 - Heart Rate (Beats Per Minute)

    The vital signs included in the assessments were blood pressure (systolic and diastolic; mmHg), heart rate (beats per minute), body temperature (°C) and respiration rate (breaths per minute).

    Measured: From first dose up to 72 weeks

  5. Summary of Vital Signs at >Day 364 - Body Temperature (°C)

    The vital signs included in the assessments were blood pressure (systolic and diastolic; mmHg), heart rate (beats per minute), body temperature (°C) and respiration rate (breaths per minute).

    Measured: From first dose up to 72 weeks

  6. Summary of Vital Signs at >Day 364 - Respiration Rate (Breaths Per Minute)

    The vital signs included in the assessments were blood pressure (systolic and diastolic; mmHg), heart rate (beats per minute), body temperature (°C) and respiration rate (breaths per minute).

    Measured: From first dose up to 72 weeks

  7. Summary of ECG Results Shift From Baseline at > Day 364

    Baseline was defined as the last non-missing value collected prior to first dose of study drug)

    Measured: From first dose up to 72 weeks

  8. Summary of Treatment-Emergent Laboratory Abnormalities With At Least a 1-grade Shift From Baseline

    Baseline was defined as the last non-missing value collected prior to first dose of study drug within a given entry into the study. The Common Terminology Criteria for Adverse Events (CTCAE), Grades 1 through 5 were used for descriptions of severity for each Adverse Event (AE): Grade 1 - Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; Grade 2 - Moderate; minimal, local or noninvasive intervention indicated; limiting age appropriate instrumental Activities of Daily Living (ADL); Grade 3 - Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL; Grade 4 - Life-threatening consequences; urgent intervention indicated; Grade 5 - Death related to AE.

    Measured: From first dose up to 72 weeks

Secondary outcomes (4)

  1. Summary of Patient Patient Global Assessment (PGA) for Constipation Severity at > Day 364

    Constipation severity was measured using a 5-point score: 1=None, 2=Mild, 3=Moderate, 4=Severe, 5=Very severe Baseline was defined as the last non-missing value collected prior to first dose of study drug within a given entry into the study.

    Measured: Form first dose up to 72 weeks

  2. Summary of Patient Global Assessment (PGA) for Constipation - Change From Baseline to > Day 364

    Change of Constipation measured using a 7-point score: 1=Very Much Improved, 2=Much Improved, 3=Minimally Improved, 4=No change, 5=Minimally Worse, 6=Much Worse, 7=Very Much Worse Baseline is defined as the last non-missing value collected prior to first dose of study drug within a given entry into the study.

    Measured: From first dose up to 72 weeks

  3. Summary of Patient Global Assessment (PGA) for Treatment Satisfaction at > Day 364

    Baseline was defined as the last non-missing value collected prior to first dose of study drug within a given entry into the study. Treatment Satisfaction was measured using a 5-point score: 1=Not At All Satisfied, 2=A Little Satisfied, 3=Moderately Satisfied, 4=Quite Satisfied, 5=Very Satisfied.

    Measured: From first dose up to 72 weeks

  4. Summary of Patient Global Assessment (PGA) for Treatment Continuation at End of Treatment

    Treatment continuation was measured using 5-point score: 1=Not At All Likely, 2=A Little Likely, 3=Moderately Likely, 4=Quite Likely, 5=Very Likely

    Measured: From first dose up to 72 weeks

Timeline

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

  1. First posted9 Aug 2013 (estimated)
  2. Study startAug 2013
  3. Primary completionJan 2016
  4. Study completionMar 2016

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,370 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01919697
Sponsor's protocol ID
SP304203-01
Status last verified
Jun 2019
First submitted
7 Aug 2013
Last updated
2 Jul 2019
Data monitoring committee
No

Publications

  • Barish CF, Griffin P. Safety and tolerability of plecanatide in patients with chronic idiopathic constipation: long-term evidence from an open-label study. Curr Med Res Opin. 2018 Apr;34(4):751-755. doi: 10.1080/03007995.2018.1430024. Epub 2018 Feb 2.

    PubMed 29343131

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Plecanatide in people with Chronic Idiopathic Constipation, run by Bausch Health Americas, Inc. at 220 sites in 2 countries.

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

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 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 2 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 220 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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 2 Jul 2019). 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?

Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE) (time frame: From first dose up to 72 weeks). The study lists 8 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 NCT01919697, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in