Reflux EsophagitisPhase 3NCT03553563

A Study of Esomeplazole (D961H) in Japanese Paediatric Patients With Reflux Esophagitis, Gastric Ulcer or Duodenal Ulcer

A Phase 3 study testing D961H capsule 10mg and D961H sachet 10mg in people with Reflux Esophagitis and Gastric Ulcer, run by AstraZeneca at 15 sites in Japan.

Completed

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

Official record

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Trial summary

This is an open label, parallel group, multi-centre, phase III study to assess the safety and efficacy of D961H in maintenance therapy following initial healing therapy in Japanese paediatric patients with reflux esophagitis, and to assess the safety and efficacy of D961H in Japanese paediatric patients treated with… Read more about this study

Who is it for?: Ages 1 year to 14 years
Conditions the study is for: Reflux Esophagitis, Gastric Ulcer, Duodenal Ulcer
What is being tested?: D961H capsule 10mg and D961H sachet 10mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 15 sitesJapan
Study dates: 24 Jul 2018to 27 Dec 2022
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 1 year to 14 years
All sexes
No healthy volunteers
Child

Who may be able to join

For healed reflux esophagitis study
Endoscopically verified reflux esophagitis, Grade A or higher according to the Los Angels classification as judged by central evaluation committee.
For prevention of gastric ulcer or duodenal ulcer recurrence study
Patients with documented medical history of gastric ulser or duodenal ulser diagnosis based on upper gastrointestinal symptoms, fecal occult blood, esophagogastroduodenoscopy findings, etc.

Who cannot join

Patients less than 10 kg in weight.
Use of any other investigational compounds or participations in another clinical trial within 4 weeks prior to the enrolment.
Significant clinical illness within 4 weeks prior to the informed consent
Previous total gastrectomy.
Presence of hepatic diseases or other conditions that could interfere with evaluation of the study as judged by investigators. etc.

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

Japan15 sites

Research Site
Bunkyō City, 113-8431
Research Site
Bunkyō City, 113-8519
Research Site
Fuji-shi, 417-8567
Research Site
Izumi-shi, 594-1101
Research Site
Kagoshima, 890-8520
Research Site
Kanazawa, 920-8641
Research Site
Maebashi, 371-8511
Research Site
Matsumoto-shi, 390-8621
Research Site
Okayama, 701-1192
Research Site
Sakaishi, 593-8304
Research Site
Setagaya-ku, 157-8535
Research Site
Shinjuku-ku, 160-0023
Research Site
Takatsuki-shi, 569-8686
Research Site
Yokohama, 230-8765
Research Site
Yokohama, 232 8555

Other trials in Japan

About this study

Official title: An Open Label, Parallel Group, Multi-centre, Phase III Study to Assess the Efficacy and Safety of D961H for the Maintenance Therapy Following Initial Treatment in Japanese Paediatric Patients With Reflux Esophagitis and for the Prevention of Recurrence of Gastric Ulcer or Duodenal Ulcer in Japanese Paediatric Patients Treated With Non-steroidal Anti-inflammatory Drugs or Low-dose Aspirin

Doses of D961H in this study is set for the 2 groups (weight more than equal 10 kg to less than 20 kg and weight more than equal 20 kg) in the maintenance therapy for healed reflux esophagitis group and the prevention of gastric ulcer or duodenal ulcer recurrence by non-steroidal anti-inflammatory drugs or low-dose aspirin therapy group, Primary endpoints are evaluated at week 32. Further, this study is designed to evaluate the long term efficacy and safety of D961H for a maximum of 52 weeks, in consideration of the medical needs for long term proton pump inhibitor treatment. Patient can continue study treatment up to 52 weeks, if they want

Read the detailed description

Subjects are allocated to four groups based on their disease and weight.

Number of Subjects

Maintenance therapy for healed reflux esophagitis study part:

Group1:aged 1 to 14 years (weight more than equal 10 kg to less than 20 kg ), Maintenance phase, n=5 to 10
Group2:aged 1 to 14 years (weight more than equal 20 kg), Maintenance phase, n=10 to 20

Prevention of gastric ulcer or duodenal ulcer recurrence associated with long term non-steroidal anti-inflammatory drugs or low-dose aspirin therapy study part:

Group3:aged 1 to 14 years (weight more than equal 10 kg to less than 20 kg), n=5 to 10 at Week 0
Group4:aged 1 to 14 years (weight more than equal 20 kg), n=10 to 20 at Week 0

All subjects have a D961H administration for 32 or 52 weeks. all esophagogastroduodenoscopy findings are reviewed by central evaluation committee and study is conducted based on the judgement of central evaluation committee.

Data are entered in electric data capture system at study site by site staffs and all data are verified with source data by site monitors during the study.

Analyses will be performed by AstraZeneca or its representatives. A comprehensive statistical analysis plan will be developed and finalised before database lock and will describe the subject populations to be included in the analyses, and procedures for accounting for missing, unused, and spurious data. This section is a summary of the planned statistical analyses of the primary and secondary endpoints. Any deviations from this plan will be reported in the clinical study report.

Efficacy analyses are intended for Efficacy Analysis Set. ・Efficacy Analysis Set:All subjects who take at least 1 dose of the investigational product and have at least 1 efficacy datum assessment during the maintenance/prevention therapy period, and who have no important protocol deviation.

All safety analyses are performed on the Safety Analysis Set.

・Safety Analysis Set:All subjects who take at least 1 dose of the investigational product and have any post-treatment assessment.

Frequency and incidence rate of adverse events (AEs), serious adverse events (SAEs), discontinuation of investigational product due to adverse events (DAEs) and other significant adverse events (OAEs) will be presented by MedDRA System Organ Class (SOC) and Preferred Term (PT) for each group. In addition, summaries of AEs will be further broken down by maximum intensity and relationship to the investigational product as assigned by investigators

Conditions: Reflux Esophagitis, Gastric Ulcer, Duodenal Ulcer
Being tested: D961H capsule 10mg, D961H sachet 10mg
Keywords: D961H, paediatric, reflux esophagitis, gastric ulcer
Medical subject headings: Esophagitis, Peptic, Stomach Ulcer, Duodenal Ulcer

What participants receive

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

D961H capsule 10mgDrug
Also called esomeprazole
All Groups can select either capsule or sachet during the study.
D961H sachet 10mgDrug
Also called esomeprazole
All Groups can select either capsule or sachet during the study.

Study groups in NCT03553563
Study group	Role	What they receive
Group1	Experimental	Initial healing phase (8 weeks), D961H 10 mg once-daily; Maintenance phase (24 or 44 weeks), D961H 10 mg once-daily Receives: Drug: D961H capsule 10mg; Drug: D961H sachet 10mg
Group2	Experimental	Initial healing phase (8 weeks), D961H 20 mg once-daily; Maintenance phase (24 or 44 weeks) starts with D961H 10 mg once-daily and may be increased to 20 mg once-daily based on investigator's discretion Receives: Drug: D961H capsule 10mg; Drug: D961H sachet 10mg
Group3	Experimental	D961H 10 mg once-daily (32 or 52 weeks) Receives: Drug: D961H capsule 10mg; Drug: D961H sachet 10mg
Group4	Experimental	D961H starts with 10 mg once-daily, and may be increased to 20 mg once-daily based on investigator's discretion (32 or 52 weeks) Receives: Drug: D961H capsule 10mg; Drug: D961H sachet 10mg

What is being measured

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

Presence/Absence of Reflux Esophagitis Relapse
Maintenance therapy for healed reflux esophagitis study part:
Presence/absence of reflux esophagitis relapse from 8 to 32 weeks for all participants by assessment of the composite endpoint (reflux esophagitis -related symptoms or optional esophagogastroduodenoscopy findings) during the maintenance therapy.
Measured: 8 to 32 weeks
Presence/Absence of Gastric Ulcer or Duodenal Ulcer Recurrence
Prevention of gastric ulcer or duodenal ulcer recurrence associated with long term non-steroidal anti-inflammatory drugs or low-dose aspirin therapy study part:
Presence/absence of gastric ulcer or duodenal ulcer recurrence from 0 to 32 weeks for all participants by assessment of the composite endpoint (gastric ulcer or duodenal ulcer-related symptoms or optional esophagogastroduodenoscopy findings) during the prevention therapy.
Measured: 0 to 32 weeks
Adverse Events During Reflux Esophagitis Maintenance Therapy
Maintenance therapy for healed reflux esophagitis study part:
Safety from 8 to 32 weeks for all participants. Number of participants with any adverse event during the period.
Measured: 8 to 32 weeks
Adverse Events During Gastric Ulcer or Duodenal Ulcer Recurrence Prevention Therapy
Prevention of gastric ulcer or duodenal ulcer recurrence associated with long term non-steroidal anti-inflammatory drugs or low-dose aspirin therapy study part:
Safety from 0 to 32 weeks for all participants. Number of participants with any adverse event during the period.
Measured: 0 to 32 weeks

Secondary outcomes (4)

Presence/Absence of Reflux Esophagitis Relapse
Presence/absence of reflux esophagitis relapse from 8 to 52 weeks for participants who continued the study treatment after Week 32 by assessment of the composite endpoint (reflux esophagitis-related symptoms or optional esophagogastroduodenoscopy findings) during the maintenance therapy.
Measured: 8 to 52 weeks
Presence/Absence of Gastric Ulcer or Duodenal Ulcer Recurrence
Presence/absence of gastric ulcer or duodenal ulcer recurrence from 0 to 52 weeks for participants who continued the study treatment after Week 32 by assessment of the composite endpoint (gastric ulcer or duodenal ulcer-related symptoms or optional esophagogastroduodenoscopy findings) during the prevention therapy.
Measured: 0 to 52 weeks
Adverse Events During Reflux Esophagitis Maintenance Therapy
Maintenance therapy for healed reflux esophagitis study part:
Safety from 8 to 52 weeks for participants who continued the study treatment after Week 32. Number of participants with any adverse event during the period
Measured: 8 to 52 weeks
Adverse Events During Gastric Ulcer or Duodenal Ulcer Recurrence Prevention Therapy
Prevention of gastric ulcer or duodenal ulcer recurrence associated with long term non-steroidal anti-inflammatory drugs or low-dose aspirin therapy study part:
Safety from 0 to 52 weeks for participants who continued the study treatment after Week 32. Number of participants with any adverse event
Measured: 0 to 52 weeks

Timeline

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

24 Jul 201827 Dec 2022

First posted12 Jun 2018
Study start24 Jul 2018
Primary completion27 Dec 2022
Study completion27 Dec 2022

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 Reflux EsophagitisStudies of the same condition, open and under way.
More trials run by AstraZenecaThe 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: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: An open label, parallel four group, multi-centre, phase III study
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03553563
Sponsor's protocol ID: D961WC00001
Other IDs: 2018-000213-20, 2018
Status last verified: Feb 2026
First submitted: 5 Apr 2018
Last updated: 4 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

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

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All Reflux Esophagitis trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label, Parallel Group, Multi-centre, Phase III Study to Assess the Efficacy and Safety of D961H for the Maintenance Therapy Following Initial Treatment in Japanese Paediatric Patients With Reflux Esophagitis and for the Prevention of Recurrence of Gastric Ulcer or Duodenal Ulcer in Japanese Paediatric Patients Treated With Non-steroidal Anti-inflammatory Drugs or Low-dose Aspirin
ClinicalTrials.gov ID: NCT03553563
Acronym / sponsor ID: D961WC00001
Conditions: Reflux Esophagitis, Gastric Ulcer, Duodenal Ulcer
Keywords: D961H, paediatric, reflux esophagitis, gastric ulcer
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 24 Jul 2018 (actual)
Primary completion: 27 Dec 2022 (actual)
Study completion: 27 Dec 2022 (actual)
First posted: 12 Jun 2018 (actual)
Results: Posted 4 Mar 2026

Clinical summary

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

Detailed description

Subjects are allocated to four groups based on their disease and weight.

Number of Subjects

Maintenance therapy for healed reflux esophagitis study part:

Group1:aged 1 to 14 years (weight more than equal 10 kg to less than 20 kg ), Maintenance phase, n=5 to 10
Group2:aged 1 to 14 years (weight more than equal 20 kg), Maintenance phase, n=10 to 20

Prevention of gastric ulcer or duodenal ulcer recurrence associated with long term non-steroidal anti-inflammatory drugs or low-dose aspirin therapy study part:

Group3:aged 1 to 14 years (weight more than equal 10 kg to less than 20 kg), n=5 to 10 at Week 0
Group4:aged 1 to 14 years (weight more than equal 20 kg), n=10 to 20 at Week 0

Data are entered in electric data capture system at study site by site staffs and all data are verified with source data by site monitors during the study.

All safety analyses are performed on the Safety Analysis Set.

・Safety Analysis Set:All subjects who take at least 1 dose of the investigational product and have any post-treatment assessment.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4
Model description: An open label, parallel four group, multi-centre, phase III study

Arm	Type	Receives
Group1	Experimental	Drug: D961H capsule 10mg, Drug: D961H sachet 10mgInitial healing phase (8 weeks), D961H 10 mg once-daily; Maintenance phase (24 or 44 weeks), D961H 10 mg once-daily
Group2	Experimental	Drug: D961H capsule 10mg, Drug: D961H sachet 10mgInitial healing phase (8 weeks), D961H 20 mg once-daily; Maintenance phase (24 or 44 weeks) starts with D961H 10 mg once-daily and may be increased to 20 mg once-daily based on investigator's discretion
Group3	Experimental	Drug: D961H capsule 10mg, Drug: D961H sachet 10mgD961H 10 mg once-daily (32 or 52 weeks)
Group4	Experimental	Drug: D961H capsule 10mg, Drug: D961H sachet 10mgD961H starts with 10 mg once-daily, and may be increased to 20 mg once-daily based on investigator's discretion (32 or 52 weeks)

Who may qualify

Ages: 1 year to 14 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

For healed reflux esophagitis study
Endoscopically verified reflux esophagitis, Grade A or higher according to the Los Angels classification as judged by central evaluation committee.
For prevention of gastric ulcer or duodenal ulcer recurrence study
Patients with documented medical history of gastric ulser or duodenal ulser diagnosis based on upper gastrointestinal symptoms, fecal occult blood, esophagogastroduodenoscopy findings, etc.

Key exclusion criteria (5 listed)

Patients less than 10 kg in weight.
Use of any other investigational compounds or participations in another clinical trial within 4 weeks prior to the enrolment.
Significant clinical illness within 4 weeks prior to the informed consent
Previous total gastrectomy.
Presence of hepatic diseases or other conditions that could interfere with evaluation of the study as judged by investigators. etc.

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
D961H capsule 10mgAlso: esomeprazoleAll Groups can select either capsule or sachet during the study.	Drug	Group1, Group2, Group3, Group4
D961H sachet 10mgAlso: esomeprazoleAll Groups can select either capsule or sachet during the study.	Drug	Group1, Group2, Group3, Group4

Primary outcome

Presence/Absence of Reflux Esophagitis Relapse
Time frame: 8 to 32 weeks
Maintenance therapy for healed reflux esophagitis study part: Presence/absence of reflux esophagitis relapse from 8 to 32 weeks for all participants by assessment of the composite endpoint (reflux esophagitis -related symptoms or optional esophagogastroduodenoscopy findings) during the maintenance therapy.
Presence/Absence of Gastric Ulcer or Duodenal Ulcer Recurrence
Time frame: 0 to 32 weeks
Prevention of gastric ulcer or duodenal ulcer recurrence associated with long term non-steroidal anti-inflammatory drugs or low-dose aspirin therapy study part: Presence/absence of gastric ulcer or duodenal ulcer recurrence from 0 to 32 weeks for all participants by assessment of the composite endpoint (gastric ulcer or duodenal ulcer-related symptoms or optional esophagogastroduodenoscopy findings) during the prevention therapy.
Adverse Events During Reflux Esophagitis Maintenance Therapy
Time frame: 8 to 32 weeks
Maintenance therapy for healed reflux esophagitis study part: Safety from 8 to 32 weeks for all participants. Number of participants with any adverse event during the period.
Adverse Events During Gastric Ulcer or Duodenal Ulcer Recurrence Prevention Therapy
Time frame: 0 to 32 weeks
Prevention of gastric ulcer or duodenal ulcer recurrence associated with long term non-steroidal anti-inflammatory drugs or low-dose aspirin therapy study part: Safety from 0 to 32 weeks for all participants. Number of participants with any adverse event during the period.

4 secondary outcomes

Presence/Absence of Reflux Esophagitis Relapse
Time frame: 8 to 52 weeks
Presence/Absence of Gastric Ulcer or Duodenal Ulcer Recurrence
Time frame: 0 to 52 weeks
Adverse Events During Reflux Esophagitis Maintenance Therapy
Time frame: 8 to 52 weeks
Adverse Events During Gastric Ulcer or Duodenal Ulcer Recurrence Prevention Therapy
Time frame: 0 to 52 weeks

Results and safety

Results posted to the registry on 4 Mar 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1	7	6
Group 2	21	18
Group 3	9	9
Group 4	13	12

Primary outcome: Presence/Absence of Reflux Esophagitis Relapse

Time frame: 8 to 32 weeks. Count of participants. Unit: Participants

Measure	Group 1 n = 7	Group 2 n = 19
Presence of reflux esophagitis relapse	0	1
Absence of reflux esophagitis relapse	7	18

Population analysed: Out of the 21 participatns in Group 2, two participants were excluded from the summary of this outcome measure. one participant discontinued the study prior to 8 weeks after the start. The other participant was not fulfilled with the inclusion criteria for the efficacy analysis set.

Primary outcome: Presence/Absence of Gastric Ulcer or Duodenal Ulcer Recurrence

Time frame: 0 to 32 weeks. Count of participants. Unit: Participants

Measure	Group 3 n = 9	Group 4 n = 13
Presence of gastric ulcer or duodenal ulcer recurrence	1	0
Absence of gastric ulcer or duodenal ulcer recurrence	8	13

Primary outcome: Adverse Events During Reflux Esophagitis Maintenance Therapy

Time frame: 8 to 32 weeks. Count of participants. Unit: Participants

Measure	Group 1 n = 7	Group 2 n = 20
Value	7	16

Population analysed: Out of the 21 participatns in Group 2, one participant was excluded from the summary of this outcome measure. This participant discontinued the study prior to 8 weeks after the start.

Primary outcome: Adverse Events During Gastric Ulcer or Duodenal Ulcer Recurrence Prevention Therapy

Time frame: 0 to 32 weeks. Count of participants. Unit: Participants

Measure	Group 3 n = 9	Group 4 n = 13
Value	8	11

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1	0 of 7 (0%)	7 of 7 (100%)	0 of 7
Group 2	1 of 21 (4.8%)	20 of 21 (95.2%)	0 of 21
Group 3	3 of 9 (33.3%)	9 of 9 (100%)	0 of 9
Group 4	2 of 13 (15.4%)	11 of 13 (84.6%)	0 of 13

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Redacted CSR SynopsisLink provided by the sponsor.
Redacted CSPLink provided by the sponsor.
Redacted SAPLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Related trials for Reflux Esophagitis

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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.

Toshiaki Shimizu, M.D., Ph.D. study chair

Juntendo University Graduate School of Medicine

15 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 D961H capsule 10mg and D961H sachet 10mg in people with Reflux Esophagitis and Gastric Ulcer, run by AstraZeneca at 15 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?

The sponsor lists 4 inclusion and 5 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 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 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 4 Mar 2026). 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?

Presence/Absence of Reflux Esophagitis Relapse (time frame: 8 to 32 weeks). The study lists 4 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 NCT03553563.

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 4 Mar 2026.