Short Bowel SyndromePhase 3NCT02340819

Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Teduglutide in Japanese Subjects With PN-dependent Short Bowel Syndrome (SBS)

A Phase 3 study testing Teduglutide in people with Short Bowel Syndrome, run by Shire at 5 sites in Japan.

Completed

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

Trial summary

The purpose of this study is to evaluate the safety and efficacy of an investigational treatment (teduglutide) in Japanese patients with PN-dependent SBS. This study will also look at how teduglutide moves through the body (pharmacokinetics). Read more about this study

Who is it for?: Ages 16 years and older
Conditions the study is for: Short Bowel Syndrome
What is being tested?: Teduglutide
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 11 participants
Where: 5 sitesJapan
Study dates: 18 Dec 2014to 5 Nov 2018
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 16 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

This study has 3 stages, consisting of an optimization/stabilization period (Stage 1), a 24-week treatment period in which all patients will receive teduglutide (Stage 2), and a long-term extension (Stage 3).

During the long-term extension (Stage 3), patients will continue to receive teduglutide for up to an additional 24 months or until teduglutide is commercially available, whichever comes earlier.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Japan5 sites

Hospital of Hyogo College of Medicine
Hyōgo, Nishinomiya, 663-8501
Osaka University Hospital, Department of Gastroenterological Surgery
Osaka, Suita, 565-0871
Osaka University Hospital, Department of Pediatric Surgery
Osaka, Suita, 565-0871
Tohoku University Hospital
Sendai, Aoba-ku, 980-8574
Yokohama Municipal Citizen's Hospital
Yokohama, Hodogaya-ku, 240-8555

Other trials in Japan

About this study

Official title: A 4-Stage, Open-label, Multicenter Study Including Long-term Extension to Evaluate the Safety, Efficacy and Pharmacokinetics of Teduglutide in Japanese Subjects With PN-dependent Short Bowel Syndrome

Conditions: Short Bowel Syndrome
Being tested: Teduglutide
Medical subject headings: Short Bowel Syndrome

What participants receive

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

TeduglutideDrug
0.05 mg/kg/day administered by subcutaneous injection over a 24-week period.

Study groups in NCT02340819
Study group	Role	What they receive
Arm 1	Experimental	0.05 mg/kg/day administered by subcutaneous injection over a 24-week period. Receives: Drug: Teduglutide

What is being measured

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

Stage 2: Absolute Change From Baseline in Weekly Parenteral Support (PS) Volume at Week 24
Absolute change from baseline in weekly PS volume at Week 24 was reported.
Measured: Baseline (stage 2), Week 24
Stage 2: Percent Change From Baseline in Weekly Parenteral Support (PS) Volume at Week 24
Percent change from baseline in weekly PS volume at Week 24 was reported.
Measured: Baseline (stage 2), Week 24
Stage 2: Percentage of Participants Who Demonstrate Response to Teduglutide at End of Stage 2
Response was defined as the achievement of at least a 20% reduction from baseline (Visit 2) in weekly PS volume at Week 20 and again at Week 24.
Measured: End of Stage 2 (up to Week 24)
Stage 2: Absolute Change From Baseline in Number of Days Per Week of Parenteral Support (PS) Usage at Week 24
Absolute change from baseline in number of days per Week of PS usage at Week 24 was reported.
Measured: Baseline (stage 2), Week 24
Stage 2: Absolute Change From Baseline in Plasma Citrulline Levels at Week 24
Plasma citrulline was measured as an assessment of enterocyte mass. Absolute change from baseline in plasma citrulline levels at Week 24 was reported.
Measured: Baseline (stage 2), Week 24
Stage 2: Percent Change From Baseline in Plasma Citrulline Levels at Week 24
Plasma citrulline was measured as an assessment of enterocyte mass. Percent change from baseline in plasma citrulline at Week 24 was reported.
Measured: Baseline (stage 2), Week 24
Stage 2: Number of Participants Who Achieved Enteral Autonomy at Week 24
Enteral autonomy was defined as no prescribed PS and no use of PS recorded in the participant diary at the end of stage 2. Number of participants who achieved enteral autonomy at Week 24 was reported.
Measured: Week 24
Stage 3: Absolute Change From Baseline in Weekly Parenteral Support (PS) Volume at Extension Month 24
Absolute change from baseline in weekly PS volume at extension Month 24 was reported. Extension month 24 = 30 months of teduglutide treatment.
Measured: Baseline (stage 3), Extension Month 24
Stage 3: Percent Change From Baseline in Weekly Parenteral Support (PS) Volume at Extension Month 24
Percent change from baseline in weekly PS volume at extension Month 24 was reported. Extension month 24 = 30 months of teduglutide treatment.
Measured: Baseline (stage 3), Extension Month 24
Stage 3: Absolute Change From Baseline in Number of Days Per Week of Parenteral Support (PS) Usage at Extension Month 24
Absolute change from baseline in number of days per Week of PS usage at extension Month 24 was reported. Extension month 24 = 30 months of teduglutide treatment.
Measured: Baseline (stage 3), Extension Month 24
Stage 3: Absolute Change From Baseline in Plasma Citrulline Levels at Extension Month 24
Plasma citrulline was measured as an assessment of enterocyte mass. Absolute change from baseline in plasma citrulline levels at extension Month 24 was reported. Extension month 24 = 30 months of teduglutide treatment.
Measured: Baseline (stage 3), Extension Month 24
Stage 3: Percent Change From Baseline in Plasma Citrulline Levels at Extension Month 24
Plasma citrulline was measured as an assessment of enterocyte mass. Percent change from baseline in plasma citrulline at extension Month 24 was reported. Extension month 24 = 30 months of teduglutide treatment.
Measured: Baseline (stage 3), Extension Month 24
Stage 4: Absolute Change From Baseline in Weekly Parenteral Support (PS) Volume at End of Treatment
Absolute change from baseline in weekly PS volume at end of treatment was reported.
Measured: Baseline (stage 4), End of Treatment (up to 47 months)
Stage 4: Percent Change From Baseline in Weekly Parenteral Support (PS) Volume at End of Treatment
Percent change from baseline in weekly PS volume at end of treatment was reported.
Measured: Baseline (stage 4), End of Treatment (up to 47 months)
Stage 4: Absolute Change From Baseline in Number of Days Per Week of Parenteral Support (PS) Usage at End of Treatment
Absolute change from baseline in number of days per week of PS usage at end of treatment was reported.
Measured: Baseline (stage 4), End of Treatment (up to 47 months)
Stage 4: Absolute Change From Baseline in Plasma Citrulline Levels at End of Treatment
Plasma citrulline was measured as an assessment of enterocyte mass. Absolute change from baseline in plasma citrulline levels at end of treatment was reported.
Measured: Baseline (stage 4), End of Treatment (up to 47 months)
Stage 4: Percent Change From Baseline in Plasma Citrulline Levels at End of Treatment
Plasma citrulline was measured as an assessment of enterocyte mass. Percent change in plasma citrulline from baseline at end of treatment was reported.
Measured: Baseline (stage 4), End of Treatment (up to 47 months)

Secondary outcomes (7)

Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-Inf) of Teduglutide in Plasma
Area under the concentration-time curve from time zero to infinity of teduglutide in plasma were evaluated.
Measured: Pre-dose, 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dose
Area Under the Concentration-Time Curve From Time Zero to the Last Time Point (AUC0-t) of Teduglutide in Plasma
Area under the concentration-time curve from time zero to the last time point of teduglutide in plasma were evaluated.
Measured: Pre-dose, 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dose
Maximum Concentration (Cmax) of Teduglutide in Plasma
Maximum concentration of teduglutide in plasma were evaluated.
Measured: Pre-dose, 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dose
Time to Reach Maximum Observed Drug Concentration (Tmax) of Teduglutide in Plasma
Time to reach maximum observed drug concentration of teduglutide in plasma was evaluated.
Measured: Pre-dose, 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dose
Terminal Half-Life (t1/2) of Teduglutide in Plasma
Terminal half-life of teduglutide in plasma were evaluated.
Measured: Pre-dose, 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dose
Apparent Clearance (CL/F) of Teduglutide in Plasma
Apparent clearance of teduglutide in plasma were evaluated.
Measured: Pre-dose, 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dose
Apparent Volume of Distribution (Vz/F) of Teduglutide in Plasma
Apparent volume of distribution of teduglutide in plasma were evaluated.
Measured: Pre-dose, 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dose

Timeline

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

18 Dec 20145 Nov 2018

First posted19 Jan 2015 (estimated)
Study start18 Dec 2014
Primary completion5 Nov 2018
Study completion5 Nov 2018

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 Short Bowel SyndromeStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02340819
Sponsor's protocol ID: TED-C14-004
Status last verified: May 2021
First submitted: 13 Nov 2014
Last updated: 9 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: De-identified individual participant data from this particular study will not be shared as there is a reasonable likelihood that individual patients could be re-identified (due to the limited number of study participants/study sites, …)

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

RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruitingPhase 3
Efficacy and Safety of PJ009 in Patients With Short Bowel Syndrome Requiring Parenteral Nutrition
Short Bowel Syndrome
Not yet recruitingPhase 2
Efficacy and Safety of TRA16 Administered Orally in Patients With Enteric Hyperoxaluria (EH).
Enteric Hyperoxaluria
RecruitingPhase 3
Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS
Short Bowel Syndrome
Active, not recruitingObservational study
Registry for Participants With Short Bowel Syndrome
Short Bowel Syndrome

All Short Bowel Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 4-Stage, Open-label, Multicenter Study Including Long-term Extension to Evaluate the Safety, Efficacy and Pharmacokinetics of Teduglutide in Japanese Subjects With PN-dependent Short Bowel Syndrome
ClinicalTrials.gov ID: NCT02340819
Acronym / sponsor ID: TED-C14-004
Conditions: Short Bowel Syndrome
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 11 participants (actual)
Lead sponsor: ShireIndustry (pharma, biotech, devices)
Study start: 18 Dec 2014 (actual)
Primary completion: 5 Nov 2018 (actual)
Study completion: 5 Nov 2018 (actual)
First posted: 19 Jan 2015 (estimated)
Results: Posted 20 Nov 2019

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Arm 1	Experimental	Drug: Teduglutide0.05 mg/kg/day administered by subcutaneous injection over a 24-week period.

Who may qualify

Ages: 16 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

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
Teduglutide0.05 mg/kg/day administered by subcutaneous injection over a 24-week period.	Drug	Arm 1

Primary outcome

Stage 2: Absolute Change From Baseline in Weekly Parenteral Support (PS) Volume at Week 24
Time frame: Baseline (stage 2), Week 24
Absolute change from baseline in weekly PS volume at Week 24 was reported.
Stage 2: Percent Change From Baseline in Weekly Parenteral Support (PS) Volume at Week 24
Time frame: Baseline (stage 2), Week 24
Percent change from baseline in weekly PS volume at Week 24 was reported.
Stage 2: Percentage of Participants Who Demonstrate Response to Teduglutide at End of Stage 2
Time frame: End of Stage 2 (up to Week 24)
Response was defined as the achievement of at least a 20% reduction from baseline (Visit 2) in weekly PS volume at Week 20 and again at Week 24.
Stage 2: Absolute Change From Baseline in Number of Days Per Week of Parenteral Support (PS) Usage at Week 24
Time frame: Baseline (stage 2), Week 24
Absolute change from baseline in number of days per Week of PS usage at Week 24 was reported.
Stage 2: Absolute Change From Baseline in Plasma Citrulline Levels at Week 24
Time frame: Baseline (stage 2), Week 24
Plasma citrulline was measured as an assessment of enterocyte mass. Absolute change from baseline in plasma citrulline levels at Week 24 was reported.
Stage 2: Percent Change From Baseline in Plasma Citrulline Levels at Week 24
Time frame: Baseline (stage 2), Week 24
Plasma citrulline was measured as an assessment of enterocyte mass. Percent change from baseline in plasma citrulline at Week 24 was reported.
Stage 2: Number of Participants Who Achieved Enteral Autonomy at Week 24
Time frame: Week 24
Enteral autonomy was defined as no prescribed PS and no use of PS recorded in the participant diary at the end of stage 2. Number of participants who achieved enteral autonomy at Week 24 was reported.
Stage 3: Absolute Change From Baseline in Weekly Parenteral Support (PS) Volume at Extension Month 24
Time frame: Baseline (stage 3), Extension Month 24
Absolute change from baseline in weekly PS volume at extension Month 24 was reported. Extension month 24 = 30 months of teduglutide treatment.
Stage 3: Percent Change From Baseline in Weekly Parenteral Support (PS) Volume at Extension Month 24
Time frame: Baseline (stage 3), Extension Month 24
Percent change from baseline in weekly PS volume at extension Month 24 was reported. Extension month 24 = 30 months of teduglutide treatment.
Stage 3: Absolute Change From Baseline in Number of Days Per Week of Parenteral Support (PS) Usage at Extension Month 24
Time frame: Baseline (stage 3), Extension Month 24
Absolute change from baseline in number of days per Week of PS usage at extension Month 24 was reported. Extension month 24 = 30 months of teduglutide treatment.
Stage 3: Absolute Change From Baseline in Plasma Citrulline Levels at Extension Month 24
Time frame: Baseline (stage 3), Extension Month 24
Plasma citrulline was measured as an assessment of enterocyte mass. Absolute change from baseline in plasma citrulline levels at extension Month 24 was reported. Extension month 24 = 30 months of teduglutide treatment.
Stage 3: Percent Change From Baseline in Plasma Citrulline Levels at Extension Month 24
Time frame: Baseline (stage 3), Extension Month 24
Plasma citrulline was measured as an assessment of enterocyte mass. Percent change from baseline in plasma citrulline at extension Month 24 was reported. Extension month 24 = 30 months of teduglutide treatment.
Stage 4: Absolute Change From Baseline in Weekly Parenteral Support (PS) Volume at End of Treatment
Time frame: Baseline (stage 4), End of Treatment (up to 47 months)
Absolute change from baseline in weekly PS volume at end of treatment was reported.
Stage 4: Percent Change From Baseline in Weekly Parenteral Support (PS) Volume at End of Treatment
Time frame: Baseline (stage 4), End of Treatment (up to 47 months)
Percent change from baseline in weekly PS volume at end of treatment was reported.
Stage 4: Absolute Change From Baseline in Number of Days Per Week of Parenteral Support (PS) Usage at End of Treatment
Time frame: Baseline (stage 4), End of Treatment (up to 47 months)
Absolute change from baseline in number of days per week of PS usage at end of treatment was reported.
Stage 4: Absolute Change From Baseline in Plasma Citrulline Levels at End of Treatment
Time frame: Baseline (stage 4), End of Treatment (up to 47 months)
Plasma citrulline was measured as an assessment of enterocyte mass. Absolute change from baseline in plasma citrulline levels at end of treatment was reported.
Stage 4: Percent Change From Baseline in Plasma Citrulline Levels at End of Treatment
Time frame: Baseline (stage 4), End of Treatment (up to 47 months)
Plasma citrulline was measured as an assessment of enterocyte mass. Percent change in plasma citrulline from baseline at end of treatment was reported.

7 secondary outcomes

Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-Inf) of Teduglutide in Plasma
Time frame: Pre-dose, 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dose
Area Under the Concentration-Time Curve From Time Zero to the Last Time Point (AUC0-t) of Teduglutide in Plasma
Time frame: Pre-dose, 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dose
Maximum Concentration (Cmax) of Teduglutide in Plasma
Time frame: Pre-dose, 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dose
Time to Reach Maximum Observed Drug Concentration (Tmax) of Teduglutide in Plasma
Time frame: Pre-dose, 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dose
Terminal Half-Life (t1/2) of Teduglutide in Plasma
Time frame: Pre-dose, 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dose
Apparent Clearance (CL/F) of Teduglutide in Plasma
Time frame: Pre-dose, 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dose
Apparent Volume of Distribution (Vz/F) of Teduglutide in Plasma
Time frame: Pre-dose, 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dose

Results and safety

Results posted to the registry on 20 Nov 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Teduglutide	11	7

Primary outcome: Stage 2: Absolute Change From Baseline in Weekly Parenteral Support (PS) Volume at Week 24

Time frame: Baseline (stage 2), Week 24. Mean (Standard Deviation). Unit: Liter per week (L/week)

Measure	Teduglutide n = 9
Value	-4.92 (4.749)

Population analysed: Intent-to-treat (ITT) population consisted of all participants who were enrolled and eligible to enter Stage 2. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.

Primary outcome: Stage 2: Percent Change From Baseline in Weekly Parenteral Support (PS) Volume at Week 24

Time frame: Baseline (stage 2), Week 24. Mean (Standard Deviation). Unit: Percent change in PS volume

Measure	Teduglutide n = 9
Value	-30.07 (25.892)

Population analysed: ITT population consisted of all participants who were enrolled and eligible to enter Stage 2. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.

Primary outcome: Stage 2: Percentage of Participants Who Demonstrate Response to Teduglutide at End of Stage 2

Time frame: End of Stage 2 (up to Week 24). Number. Unit: Percentage of Participants

Measure	Teduglutide n = 11
PS Response: Yes	45.5
PS Response: No	54.5

Population analysed: ITT population consisted of all participants who were enrolled and eligible to enter Stage 2.

Primary outcome: Stage 2: Absolute Change From Baseline in Number of Days Per Week of Parenteral Support (PS) Usage at Week 24

Time frame: Baseline (stage 2), Week 24. Mean (Standard Deviation). Unit: Days per week (days/week)

Measure	Teduglutide n = 9
Value	-1.0 (1.80)

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: From start of study treatment up to end of the study (up to 47 months). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Teduglutide	7 of 11 (63.6%)	11 of 11 (100%)	1 of 11

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. De-identified individual participant data from this particular study will not be shared as there is a reasonable likelihood that individual patients could be re-identified (due to the limited number of study participants/study sites, …)

Related trials for Short Bowel Syndrome

RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruitingPhase 3
Efficacy and Safety of PJ009 in Patients With Short Bowel Syndrome Requiring Parenteral Nutrition
Short Bowel Syndrome
Not yet recruitingPhase 2
Efficacy and Safety of TRA16 Administered Orally in Patients With Enteric Hyperoxaluria (EH).
Enteric Hyperoxaluria
RecruitingPhase 3
Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS
Short Bowel Syndrome
Active, not recruitingObservational study
Registry for Participants With Short Bowel Syndrome
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Study Director study director

Takeda

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Teduglutide in people with Short Bowel Syndrome, run by Shire at 5 sites in Japan.

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

Who may be eligible to take part?

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 9 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Japan. 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 20 Nov 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?

Stage 2: Absolute Change From Baseline in Weekly Parenteral Support (PS) Volume at Week 24 (time frame: Baseline (stage 2), Week 24). The study lists 17 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 NCT02340819.

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 9 Jun 2021.