Constipation - FunctionalPhase 3NCT02042183

Lubiprostone in Children With Functional Constipation

A Phase 3 study testing Lubiprostone in people with Constipation - Functional, run by Sucampo Pharma Americas, LLC at 117 sites in 7 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

Study to determine if children (6-17 years old) with functional constipation will respond to being treated with lubiprostone for 12 weeks. Read more about this study

Who is it for?: Ages 6 to 17 years
Conditions the study is for: Constipation - Functional
What is being tested?: Lubiprostone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 606 participants
Where: 117 sitesin 7 countries
Study dates: 13 Dec 2013to 27 Jul 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 6 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Medically-confirmed diagnosis of Functional Constipation per Rome III Diagnostic Criteria for Childhood Functional Constipation
At least 6 years of age but less than 18 years of age at the time of randomisation
Only stable dose of selective serotonin re-uptake inhibitors (SSRIs), serotonin-specific reuptake inhibitor (SNRIs), or monoamine oxidase inhibitors (MAO) inhibitors are allowed if subject is taking antidepressants

Who cannot join

Any gastrointestinal (GI) condition, other than constipation and/or irritable bowel syndrome (IBS), affecting GI motility or defecation
Untreated faecal impaction at the time of screening
Medical/surgical condition that might interfere with the absorption, distribution, metabolism, or excretion of the study medication

Trial locations and contacts

117 sites in 7 countries.

Country

City, postcode or hospital

117 sites in 7 countries

United States87 sites

Texas Tech University Health Sciences Center
Amarillo, Texas, 79106
Children's Center for Digestive Healthcare/GI Care for Kids
Atlanta, Georgia, 30342
Austin Center for Clinical Research
Austin, Texas, 78756
Johns Hopkins Children's Center
Baltimore, Maryland, 21287
A1 Clinical Research
Baytown, Texas, 77521
PriMed Clinical Research
Beavercreek, Ohio, 45431
Pioneer Clinical Research
Bellevue, Nebraska, 68005
Northwest Clinicial Research Center
Bellevue, Washington, 98007
University of Alabama Pediatric Gastroenterology
Birmingham, Alabama, 35233
Boston Children's Hospital
Boston, Massachusetts, 02115
Digestive Diseases and Nutrition Center Women and Childrens Hospital of Buffalo
Buffalo, New York, 14222
University of Vermont Medical Center
Burlington, Vermont, 05445
UNC School of Medicine
Chapel Hill, North Carolina, 27599
Coastal Pediatric Associates - James Island
Charleston, South Carolina, 29412
Coastal Clinical Research
Charleston, South Carolina, 29414
Pediatric Research of Charlottesville, LLC
Charlottesville, Virginia, 22902
MCB Clinical Research
Colorado Springs, Colorado, 80910
Nationwide Children's Hospital
Columbus, Ohio, 43205
3rd Coast Research Associates
Corpus Christi, Texas, 78413
WCCT Global
Costa Mesa, California, 92626
Childrens Medical Center Dallas
Dallas, Texas, 75390
UnityPoint Health Des Moines/ Blank Children's Clinic
Des Moines, Iowa, 50309
Square-1 Clinical Research, Inc.
Erie, Pennsylvania, 16506
INOVA Pediatric Digestive Diseases Center
Fairfax, Virginia, 22031
Northwest Arkansas Pediatric Clinic
Fayetteville, Arkansas, 72703
Cook Children's Medical Center
Fort Worth, Texas, 76104
University of Florida
Gainesville, Florida, 32610
Greenville Health System
Greenville, South Carolina, 29615
Cyn3rgy Research
Gresham, Oregon, 97030
Palmetto Professional Research
Hialeah, Florida, 33016
Baylor College of Medicine
Houston, Texas, 77030
University of Iowa Children's Hospital
Iowa City, Iowa, 52242
Gastrointestinal Associates, PA
Jackson, Mississippi, 39202
University of Mississippi Medical Center
Jackson, Mississippi, 39216
The Jackson Clinic, P.C.
Jackson, Tennessee, 38305
Smart Medical Research, Inc.
Jackson Heights, New York, 11372
Nemours Children's Clinic
Jacksonville, Florida, 32207
The Children's Mercy Hospital
Kansas City, Missouri, 64145
Envision Clinical Research, LLC
Laredo, Texas, 78041
Midwest Children's Health Research Institute
Lincoln, Nebraska, 68504
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, 72202
Applied Clinical Research of Arkansas
Little Rock, Arkansas, 72212
Bridgerland Clinical Research
Logan, Utah, 84341
Loma Linda University Health Care
Loma Linda, California, 92350
DCOL Center for Clinical Research
Longview, Texas, 75605
Children's Hospital Los Angeles
Los Angeles, California, 90027
University of Louisville Research Foundation Inc. Kosair Charities Pediatric Clinical Research Unit
Louisville, Kentucky, 40202
Le Bonheur Children's Hospital
Memphis, Tennessee, 38105
Acevedo Clinical Research Associates
Miami, Florida, 33142
Savin Medical Group Research Center
Miami Lakes, Florida, 33014
Medical College of Wisconsin
Milwaukee, Wisconsin, 58226
University of South Alabama Women's and Children's Hospital
Mobile, Alabama, 36604
Coastal Pediatrics Associates - Mount Pleasant
Mt. Pleasant, South Carolina, 29464
Monroe Carell Junior Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232
Children's Hospital
New Orleans, Louisiana, 70118
NY Presbyterian Weill Cornell
New York, New York, 10021
Morgan Stanley Children's Hospital of New York Presbyterian
New York, New York, 10032
PediaResearch, LLC - Newburgh
Newburgh, Indiana, 47630
The Children's Hospital of the King's Daughter
Norfolk, Virginia, 23507
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Children's Hospital of Orange County
Orange, California, 92868
Digestive & Liver Center of Florida
Orlando, Florida, 32819
PediaResearch, LLC - Owensboro
Owensboro, Kentucky, 42301
Center For Children's Digestive Health
Park Ridge, Illinois, 60068
Nemours Childrens Clinic
Pensacola, Florida, 32504
Methodist Medical Center
Peoria, Illinois, 61602
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
St. Christopher's Hospital for Children/Drexel University
Philadelphia, Pennsylvania, 19134
Arizona Children's Center at Maricopa Medical Center
Phoenix, Arizona, 85008
Phoenix Children's Hospital
Phoenix, Arizona, 85016
Children's Hospital of Pittsburgh UPMC
Pittsburgh, Pennsylvania, 15224
Zain Research LLC
Richland, Washington, 99352
Pediatric Gastroenterology Carilion Medical Center
Roanoke, Virginia, 24014
Mayo Clinic
Rochester, Minnesota, 55905
Primary Children's Medical Center
Salt Lake City, Utah, 84132
University of California, San Francisco
San Francisco, California, 94143
Medical Clinics of Sealy
Sealy, Texas, 77474
Willis-Knighton Physician Network
Shreveport, Louisiana, 71101
Virgo-Carter Pediatrics
Silver Spring, Maryland, 20910
Spartanburg Medical Research
Spartanburg, South Carolina, 29303
Wee Care Pediatrics
Syracuse, Utah, 84075
MultiCare Health System Institute for Research and Innovation
Tacoma, Washington, 98405
Toledo Children's Hospital
Toledo, Ohio, 43606
AAPRI Clinical Research
Warwick, Rhode Island, 02886
Emmerson Clinical Research
Washington D.C., District of Columbia, 20020
Heartland Research Associates
Wichita, Kansas, 67205
Nemours/Alfred I. duPont Hospital for Children
Wilmington, Delaware, 19803

Other trials in United States

Poland9 sites

Medical University of Bialystok
Bialystok, 15-274
Szpital Uniwersytecki
Bydgoszcz, 85-168
ATOPIA Poradnie Specjalistyczne
Krakow, 31-159
Medical University of Lodz
Lodz, 91-738
Szpital Pediatryczny ICZMP
Lodz, 93-338
Gabinet Lekarski Bartosc Korczowski
Rzeszów, 35-210
Children's Memorial Health Institute
Warsaw, 00-632
Przychodnia Specjalistyczna PROSEN
Warsaw, 01-231
Children's Memorial Health Institute
Warsaw, 04-730

Other trials in Poland

United Kingdom7 sites

Kent and Canterbury Hospital
Canterbury, CT1 3NG
Darlington Memorial Hospital
Darlington, DL3 6HZ
Royal Hospital for Sick Children
Glasgow, G3 8SJ
Royal London Hospital
London, E1 1BB
Chelsea and Westminster Hospital NHS Foundation Trust
London, SW10 9NH
Great Ormond Street Hospital for children NHS Foundation Trust
London, WC1N 3JH
Sheffield Children Hospital
Sheffield, S10 2TH

Other trials in United Kingdom

France4 sites

CHU-Bordeaux
Bordeaux, 33000
Groupe Hospitalier Est
Bron, 69677
Armand-Trousseau Teaching Hospital
Paris, 75012
Hôpital Necker
Paris, 75743

Other trials in France

Netherlands4 sites

Emma Children's Hospital
Amsterdam, 1105 AZ
Amphia Ziekenhuis
Breda, 4800 RK
Maasstad Hospital Rotterdam
Rotterdam, 3079 DZ
Isala Klinieken
Zwolle, 8025 AB

Other trials in Netherlands

Belgium3 sites

Universitair Kinderziekenhuis Brussel
Brussels, 01090
University Hospital Gasthuisberg
Leuven, 03000
CHC - Clinique Saint-Joseph
Montegnée, 04420

Other trials in Belgium

Canada3 sites

London Health Sciences Centre
London, Ontario, N6C 2V5
Sainte Justine University Health Center
Montreal, H3T 1C5
Centre de recherche du CHUS
Sherbrooke, Quebec, J1H 5N4

Other trials in Canada

About this study

Official title: A Multicentre, Randomised, Placebo-controlled, Double-blinded Study of the Efficacy, Safety, and Pharmacokinetics of Lubiprostone in Paediatric Subjects Aged ≥ 6 Years to < 18 Years With Functional Constipation

Study to determine if children (6-17 years old) with functional constipation will respond to being treated with lubiprostone for 12 weeks.

Read the detailed description

Dose administration details:

Participants with a body weight <50 kg at baseline received Lubiprostone 12 mcg BID for 12 weeks. If the dose was safe but did not show any efficacy at Week 1, dosage was increased to 24 mcg BID.
Participants with a body weight >50 kg at baseline received Lubiprostone 24 mcg BID for 12 weeks. If the dose was unsafe at Week 1, dosage was decreased to 12 mcg BID.

Conditions: Constipation - Functional
Being tested: Lubiprostone, Placebo

What participants receive

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

LubiprostoneDrug
Also called Amitiza
12 or 24 mcg soft capsules of lubiprostone for oral administration, depending on baseline weight and response during week 1
PlaceboDrug
Also called Matching Placebo
0 mcg soft capsules of placebo for oral administration

Study groups in NCT02042183
Study group	Role	What they receive
Lubiprostone	Experimental	Participants receive lubiprostone twice daily (BID) up to 12 weeks Receives: Drug: Lubiprostone
Placebo	Placebo comparator	Participants receive placebo BID up to 12 weeks Receives: Drug: Placebo

What is being measured

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

Number of Participants Classified as Overall Responders at Week 12
An overall responder is defined as a participant who qualified as a weekly responder for 9 of the 12 treatment weeks, with durability demonstrated by at least 3 of the responder weeks occurring during the last 4 weeks of the treatment period. A weekly responder is defined as a participant who has at least 3 spontaneous bowel movements during the week, and at least one more than at baseline.
Measured: at Week 12

Secondary outcomes (1)

Mean Number of SBMs Observed Each Week for 12 Weeks
Data provided is based on observed cases. Baseline is the average of the 2 weeks before being randomized. Participants are summarized by actual dose received after week 1.
Measured: within 12 Weeks

Timeline

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

13 Dec 201327 Jul 2016

First posted22 Jan 2014 (estimated)
Study start13 Dec 2013
Primary completion27 Jul 2016
Study completion27 Jul 2016

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Constipation - FunctionalStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Placebo controlled
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 606 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02042183
Sponsor's protocol ID: SAG/0211PFC-1131
Other IDs: 2013-004384-31, EMEA-000245-PIP01-08
Status last verified: Jul 2020
First submitted: 17 Jan 2014
Last updated: 21 Jul 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Basic results are provided here, with statistical results and discussion reserved for publications.

Publications

Benninga MA, Hussain SZ, Sood MR, Nurko S, Hyman P, Clifford RA, O'Gorman M, Losch-Beridon T, Mareya S, Lichtlen P, Di Lorenzo C. Lubiprostone for Pediatric Functional Constipation: Randomized, Controlled, Double-Blind Study With Long-term Extension. Clin Gastroenterol Hepatol. 2022 Mar;20(3):602-610.e5. doi: 10.1016/j.cgh.2021.04.005. Epub 2021 Apr 7.
PubMed 33838349

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

Not yet recruitingPhase 3
Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders
Bloating, Rifaximin
Recruiting
Effects of Connective Tissue Massage Plus Biofeedback for Dyssynergic Defecation
Dyssynergic Defecation
RecruitingObservational study
Relationship Between Interoception and Postural Control in Constipation-Predominant Irritable Bowel Syndrome
Constipation, Irritable Bowel Disease
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
RecruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)

All Constipation - Functional trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicentre, Randomised, Placebo-controlled, Double-blinded Study of the Efficacy, Safety, and Pharmacokinetics of Lubiprostone in Paediatric Subjects Aged ≥ 6 Years to < 18 Years With Functional Constipation
ClinicalTrials.gov ID: NCT02042183
Acronym / sponsor ID: SAG/0211PFC-1131
Conditions: Constipation - Functional
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 606 participants (actual)
Lead sponsor: Sucampo Pharma Americas, LLCIndustry (pharma, biotech, devices)
Collaborators: Sucampo AG
Study start: 13 Dec 2013 (actual)
Primary completion: 27 Jul 2016 (actual)
Study completion: 27 Jul 2016 (actual)
First posted: 22 Jan 2014 (estimated)
Results: Posted 21 Jul 2020

Clinical summary

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

Study to determine if children (6-17 years old) with functional constipation will respond to being treated with lubiprostone for 12 weeks.

Detailed description

Dose administration details:

Participants with a body weight <50 kg at baseline received Lubiprostone 12 mcg BID for 12 weeks. If the dose was safe but did not show any efficacy at Week 1, dosage was increased to 24 mcg BID.
Participants with a body weight >50 kg at baseline received Lubiprostone 24 mcg BID for 12 weeks. If the dose was unsafe at Week 1, dosage was decreased to 12 mcg BID.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: Placebo controlled

Arm	Type	Receives
Lubiprostone	Experimental	Drug: LubiprostoneParticipants receive lubiprostone twice daily (BID) up to 12 weeks
Placebo	Placebo comparator	Drug: PlaceboParticipants receive placebo BID up to 12 weeks

Who may qualify

Ages: 6 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

Medically-confirmed diagnosis of Functional Constipation per Rome III Diagnostic Criteria for Childhood Functional Constipation
At least 6 years of age but less than 18 years of age at the time of randomisation
Only stable dose of selective serotonin re-uptake inhibitors (SSRIs), serotonin-specific reuptake inhibitor (SNRIs), or monoamine oxidase inhibitors (MAO) inhibitors are allowed if subject is taking antidepressants

Key exclusion criteria (3 listed)

Any gastrointestinal (GI) condition, other than constipation and/or irritable bowel syndrome (IBS), affecting GI motility or defecation
Untreated faecal impaction at the time of screening
Medical/surgical condition that might interfere with the absorption, distribution, metabolism, or excretion of the study medication

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
LubiprostoneAlso: Amitiza12 or 24 mcg soft capsules of lubiprostone for oral administration, depending on baseline weight and response during week 1	Drug	Lubiprostone
PlaceboAlso: Matching Placebo0 mcg soft capsules of placebo for oral administration	Drug	Placebo

Primary outcome

Number of Participants Classified as Overall Responders at Week 12
Time frame: at Week 12
An overall responder is defined as a participant who qualified as a weekly responder for 9 of the 12 treatment weeks, with durability demonstrated by at least 3 of the responder weeks occurring during the last 4 weeks of the treatment period. A weekly responder is defined as a participant who has at least 3 spontaneous bowel movements during the week, and at least one more than at baseline.

1 secondary outcome

Mean Number of SBMs Observed Each Week for 12 Weeks
Time frame: within 12 Weeks

Results and safety

Results posted to the registry on 21 Jul 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lubiprostone	404	339
Placebo	202	166

Primary outcome: Number of Participants Classified as Overall Responders at Week 12

Time frame: at Week 12. Count of participants. Unit: Participants

Measure	Lubiprostone n = 399	Placebo n = 195
Value	76	28

Lubiprostone vs Placebo: p = 0.1609, Cochran-Mantel-Haenszel

Population analysed: mITT population

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Treatment emergent adverse events (TEAEs) in the safety population are reported for 14 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lubiprostone	11 of 400 (2.8%)	234 of 400 (58.5%)	0 of 400
Placebo	7 of 195 (3.6%)	82 of 195 (42.1%)	0 of 195

Limitations and caveats (from the sponsor): Outcome measures were not identified as such in the protocol, and some tables were recalculated at the request of the Food and Drug Administration, so revised data necessary to calculate the primary endpoint were posted.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33838349Benninga MA, Hussain SZ, Sood MR, Nurko S, Hyman P, Clifford RA, O'Gorman M, Losch-Beridon T, Mareya S, Lichtlen P, Di Lorenzo C. Lubiprostone for Pediatric Functional Constipation: Randomized, Controlled, Double-Blind Study With Long-term Extension. Clin Gastroenterol Hepatol. 2022 Mar;20(3):602-610.e5. doi: 10.1016/j.cgh.2021.04.005. Epub 2021 Apr 7.
Individual participant dataSharing planned: No. Basic results are provided here, with statistical results and discussion reserved for publications.

Related trials for Constipation - Functional

Not yet recruitingPhase 3
Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders
Bloating, Rifaximin
Recruiting
Effects of Connective Tissue Massage Plus Biofeedback for Dyssynergic Defecation
Dyssynergic Defecation
RecruitingObservational study
Relationship Between Interoception and Postural Control in Constipation-Predominant Irritable Bowel Syndrome
Constipation, Irritable Bowel Disease
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
RecruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)

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.

Clinical Team Leader study director

Mallinckrodt

117 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lubiprostone in people with Constipation - Functional, run by Sucampo Pharma Americas, LLC at 117 sites in 7 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 3 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 21 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 117 sites in United States, Poland, United Kingdom, France, Netherlands and 2 more countries. 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. Some participants in this study may receive a placebo. 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 21 Jul 2020). 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 Participants Classified as Overall Responders at Week 12 (time frame: at Week 12). 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 NCT02042183, 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 21 Jul 2020.