Gastric Ulcer (GU)Phase 3NCT02153398

A Phase I/III Study of D961H 10 mg and 20 mg in Japanese Paediatric Patients With Gastrointestinal Acid Related Diseases

A Phase 3 study testing D961H sachet 10 mg, D961H capsule 10mg and D961H capsule 20 mg in people with Gastric Ulcer (GU) and Duodenal Ulcer (DU), 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

The objective of this study is to assess the safety, pharmacokinetics, pharmacodynamics and efficacy of repeated once daily oral administration of D961H 10 mg and D961H 20 mg in Japanese paediatric patients aged 1 to 14 years old who either have a diagnosis of or are suspected to have gastric ulcer (GU), duodenal… Read more about this study

Who is it for?: Ages 1 year to 14 years
Conditions the study is for: Gastric Ulcer (GU), Duodenal Ulcer (DU), Anastomotic Ulcer (AU)
What is being tested?: D961H sachet 10 mg, D961H capsule 10mg and D961H capsule 20 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 55 participants
Where: 15 sitesJapan
Study dates: Jun 2014to Apr 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 1 year to 14 years
All sexes
No healthy volunteers
Child

Who may be able to join

Provision of signed written informed consent from the patient's guardian
Patients aged ≥ 1 year to 14 years old
Patients who have a diagnosis of or suspected to have GU, DU, AU, NERD, RE or Zollinger-Ellison syndrome.

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 randomisation/registration.
Significant clinical illness within 4 weeks prior to the registration
Presence of hepatic diseases or other conditions that could interfere with evaluation of the study as judged by the investigators.
Positive for pregnancy test by urinary or lactation for post-menarchal females.
Previous total gastrectomy

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

Japan15 sites

Research Site
Bunkyō City
Research Site
Fukuoka
Research Site
Hiroshima
Research Site
Izumi-shi
Research Site
Maebashi
Research Site
Matsumoto-shi
Research Site
Osaka
Research Site
Saitama-shi
Research Site
Sapporo
Research Site
Setagaya-ku
Research Site
Shimotsuke-shi
Research Site
Shinjuku-ku
Research Site
Suzaka-shi
Research Site
Ureshino-shi
Research Site
Yokohama

Other trials in Japan

About this study

Official title: An Open-label, Parallel-group, Multi-centre, Phase I/III Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Repeated Once-daily Oral Administration of D961H 10 mg and D961H 20 mg in Japanese Paediatric Patients 1 to 14 Years Old With Gastrointestinal Acid Related Diseases

Conditions: Gastric Ulcer (GU), Duodenal Ulcer (DU), Anastomotic Ulcer (AU), Non-erosive Reflux Esophagitis Disease (NERD), Reflux Esophagitis (RE), Zollinger-Ellison Syndrome
Being tested: D961H sachet 10 mg, D961H capsule 10mg, D961H capsule 20 mg
Keywords: Gastric ulcer (GU), Duodenal ulcer (DU), Anastomotic ulcer (AU), Non-erosive reflux esophagitis disease (NERD), Reflux esophagitis (RE), Zollinger-Ellison syndrome
Medical subject headings: Stomach Ulcer, Duodenal Ulcer, Esophagitis, Peptic, Zollinger-Ellison Syndrome

What participants receive

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

D961H sachet 10 mgDrug
D961H capsule 10mgDrug
D961H capsule 20 mgDrug

Study groups in NCT02153398
Study group	Role	What they receive
Group 1: D961H sachet 10 mg	Experimental	Age: ≥1 year Weight: <20 kg Receives: Drug: D961H sachet 10 mg
Group 2: D961H capsule 10mg	Experimental	Age: ≥1 year to 11years Weight: ≥20 kg Receives: Drug: D961H capsule 10mg
Group 3: D961H capsule 20 mg	Experimental	Age: ≥1 year to 11years Weight: ≥20 kg Receives: Drug: D961H capsule 20 mg
Group 4: D961H capsule 10 mg	Experimental	Age: 12 to 14 years Weight: ≥20 kg Receives: Drug: D961H capsule 10mg
Group 5: D961H capsule 20 mg	Experimental	Age: 12 to 14 years Weight: ≥20 kg Receives: Drug: D961H capsule 20 mg

What is being measured

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

Disappearance of Heartburn at Week 8 by Patient Diaries
The disappearance of heartburn was assessed by the intensity of the symptom at Week 8. Patients who recognized disappearance of heartburn were defined as those who selected "Mild", "Moderate", or "Severe" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "None" at Week 8.
Measured: 8 weeks
Disappearance of Epigastric Pain at Week 8 by Patient Diaries
The disappearance of epigastric pain was assessed by the intensity of the symptom at Week 8. Patients who recognized disappearance of epigastric pain were defined as those who selected "Mild", "Moderate", or "Severe" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "None" at Week 8.
Measured: 8 weeks
Disappearance of Upper Abdominal Discomfort at Week 8 by Patient Diaries
The disappearance of upper abdominal discomfort was assessed by the intensity of the symptom at Week 8. Patients who recognized disappearance of upper abdominal discomfort were defined as those who selected "Mild", "Moderate", or "Severe" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "None" at Week 8.
Measured: 8 weeks
Disappearance of Regurgitation at Week 8 by Patient Diaries
The disappearance of regurgitation was assessed by the intensity of the symptom at Week 8. Patients who recognized disappearance of regurgitation were defined as those who selected "Mild", "Moderate", or "Severe" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "None" at Week 8.
Measured: 8 weeks
Aggravation of Heartburn at Week 8 by Patient Diaries
The aggravation of heartburn was assessed by the intensity of the symptom at Week 8. Patients who recognized aggravation of heartburn were defined as those who selected "None" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "Mild", "Moderate" or "Severe" at Week 8.
Measured: 8 weeks
Aggravation of Epigastric Pain at Week 8 by Patient Diaries
The aggravation of epigastric pain was assessed by the intensity of the symptom at Week 8. Patients who recognized aggravation of epigastric pain were defined as those who selected "None" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "Mild", "Moderate" or "Severe" at Week 8.
Measured: 8 weeks
Aggravation of Upper Abdominal Discomfort at Week 8 by Patient Diaries
The aggravation of upper abdominal discomfort was assessed by the intensity of the symptom at Week 8. Patients who recognized aggravation of upper abdominal discomfort were defined as those who selected "None" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "Mild", "Moderate" or "Severe" at Week 8.
Measured: 8 weeks
Aggravation of Regurgitation at Week 8 by Patient Diaries
The aggravation of regurgitation was assessed by the intensity of the symptom at Week 8. Patients who recognized aggravation of regurgitation were defined as those who selected "None" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "Mild", "Moderate" or "Severe" at Week 8.
Measured: 8 weeks
Disappearance of Heartburn at Week 8 by Investigators
The investigators assessed the presence/absence and the intensity of heartburn at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized disappearance of heartburn were defined as those who had a heartburn at pre-dose and did not have the corresponding symptoms at Week 8 judged by investigators.
Measured: 8 weeks
Disappearance of Epigastric Pain at Week 8 by Investigators
The investigators assessed the presence/absence and the intensity of epigastric pain at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized disappearance of epigastric pain were defined as those who had an epigastric pain at pre-dose and did not have the corresponding symptoms at Week 8 judged by investigators.
Measured: 8 weeks
Disappearance of Upper Abdominal Discomfort at Week 8 by Investigators
The investigators assessed the presence/absence and the intensity of upper abdominal discomfort at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized disappearance of upper abdominal discomfort were defined as those who had an upper abdominal discomfort at pre-dose and did not have the corresponding symptoms at Week 8 judged by investigators.
Measured: 8 weeks
Disappearance of Regurgitation at Week 8 by Investigators
The investigators assessed the presence/absence and the intensity of regurgitation at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized disappearance of regurgitation were defined as those who had a regurgitation at pre-dose and did not have the corresponding symptoms at Week 8 judged by investigators.
Measured: 8 weeks
Aggravation of Heartburn at Week 8 by Investigators
The investigators assessed the presence/absence and the intensity of heartburn at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized aggravation of heartburn were defined as those who had no heartburn at pre-dose and did have any of the corresponding symptoms at Week 8 judged by investigators.
Measured: 8 weeks
Aggravation of Epigastric Pain at Week 8 by Investigators
The investigators assessed the presence/absence and the intensity of epigastric pain at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized aggravation of epigastric pain were defined as those who had no epigastric pain at pre-dose and did have any of the corresponding symptoms at Week 8 judged by investigators.
Measured: 8 weeks
Aggravation of Upper Abdominal Discomfort at Week 8 by Investigators
The investigators assessed the presence/absence and the intensity of upper abdominal discomfort at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized aggravation of upper abdominal discomfort were defined as those who had no upper abdominal discomfort at pre-dose and did have any of the corresponding symptoms at Week 8 judged by investigators.
Measured: 8 weeks
Aggravation of Regurgitation at Week 8 by Investigators
The investigators assessed the presence/absence and the intensity of regurgitation at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized aggravation of regurgitation were defined as those who had no regurgitation at pre-dose and did have any of the corresponding symptoms at Week 8 judged by investigators.
Measured: 8 weeks

Secondary outcomes (7)

Area Under the Plasma Concentration-time Curve During a Dosing Interval (AUCtau) of Esomeprazole After at Least 5 Days of Repeated Dose
Measured: 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose
AUC From Time Zero to Time of Last Quantifiable Concentration (AUC0-t) of Esomeprazole After at Least 5 Days of Repeated Dose
Measured: 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose
Maximum Plasma Concentration (Cmax) of Esomeprazole After at Least 5 Days of Repeated Dose
Measured: 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose
Time to Reach Maximum Plasma Concentration (Tmax) of Esomeprazole After at Least 5 Days of Repeated Dose
Measured: 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose
Elimination Half-life (t1/2) of Esomeprazole After at Least 5 Days of Repeated Dose
Measured: 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose
Apparent Total Clearance (CL/F) of Esomeprazole After at Least 5 Days of Repeated Dose
Measured: 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose
Apparent Volume of Distribution (Vz/F) of Esomeprazole After at Least 5 Days of Repeated Dose
Measured: 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose

Timeline

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

Jun 2014Apr 2016

First posted3 Jun 2014 (estimated)
Study startJun 2014
Primary completionApr 2016
Study completionApr 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.
Other trials for Gastric Ulcer (GU)Studies 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 55 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02153398
Sponsor's protocol ID: D961TC00002
Other IDs: 26-022
Status last verified: Nov 2016
First submitted: 30 May 2014
Last updated: 19 Jan 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 19 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Parallel-group, Multi-centre, Phase I/III Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Repeated Once-daily Oral Administration of D961H 10 mg and D961H 20 mg in Japanese Paediatric Patients 1 to 14 Years Old With Gastrointestinal Acid Related Diseases
ClinicalTrials.gov ID: NCT02153398
Acronym / sponsor ID: D961TC00002
Conditions: Gastric Ulcer (GU), Duodenal Ulcer (DU), Anastomotic Ulcer (AU), Non-erosive Reflux Esophagitis Disease (NERD), Reflux Esophagitis (RE), Zollinger-Ellison Syndrome
Keywords: Gastric ulcer (GU), Duodenal ulcer (DU), Anastomotic ulcer (AU), Non-erosive reflux esophagitis disease (NERD), Reflux esophagitis (RE), Zollinger-Ellison syndrome
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 55 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Jun 2014
Primary completion: Apr 2016 (actual)
Study completion: Apr 2016 (actual)
First posted: 3 Jun 2014 (estimated)
Results: Posted 19 Jan 2017

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Group 1: D961H sachet 10 mg	Experimental	Drug: D961H sachet 10 mgAge: ≥1 year Weight: <20 kg
Group 2: D961H capsule 10mg	Experimental	Drug: D961H capsule 10mgAge: ≥1 year to 11years Weight: ≥20 kg
Group 3: D961H capsule 20 mg	Experimental	Drug: D961H capsule 20 mgAge: ≥1 year to 11years Weight: ≥20 kg
Group 4: D961H capsule 10 mg	Experimental	Drug: D961H capsule 10mgAge: 12 to 14 years Weight: ≥20 kg
Group 5: D961H capsule 20 mg	Experimental	Drug: D961H capsule 20 mgAge: 12 to 14 years Weight: ≥20 kg

Who may qualify

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

Key inclusion criteria (3 listed)

Provision of signed written informed consent from the patient's guardian
Patients aged ≥ 1 year to 14 years old
Patients who have a diagnosis of or suspected to have GU, DU, AU, NERD, RE or Zollinger-Ellison syndrome.

Key exclusion criteria (6 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 randomisation/registration.
Significant clinical illness within 4 weeks prior to the registration
Presence of hepatic diseases or other conditions that could interfere with evaluation of the study as judged by the investigators.
Positive for pregnancy test by urinary or lactation for post-menarchal females.

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 sachet 10 mg	Drug	Group 1: D961H sachet 10 mg
D961H capsule 10mg	Drug	Group 2: D961H capsule 10mg, Group 4: D961H capsule 10 mg
D961H capsule 20 mg	Drug	Group 3: D961H capsule 20 mg, Group 5: D961H capsule 20 mg

Primary outcome

Disappearance of Heartburn at Week 8 by Patient Diaries
Time frame: 8 weeks
The disappearance of heartburn was assessed by the intensity of the symptom at Week 8. Patients who recognized disappearance of heartburn were defined as those who selected "Mild", "Moderate", or "Severe" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "None" at Week 8.
Disappearance of Epigastric Pain at Week 8 by Patient Diaries
Time frame: 8 weeks
The disappearance of epigastric pain was assessed by the intensity of the symptom at Week 8. Patients who recognized disappearance of epigastric pain were defined as those who selected "Mild", "Moderate", or "Severe" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "None" at Week 8.
Disappearance of Upper Abdominal Discomfort at Week 8 by Patient Diaries
Time frame: 8 weeks
The disappearance of upper abdominal discomfort was assessed by the intensity of the symptom at Week 8. Patients who recognized disappearance of upper abdominal discomfort were defined as those who selected "Mild", "Moderate", or "Severe" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "None" at Week 8.
Disappearance of Regurgitation at Week 8 by Patient Diaries
Time frame: 8 weeks
The disappearance of regurgitation was assessed by the intensity of the symptom at Week 8. Patients who recognized disappearance of regurgitation were defined as those who selected "Mild", "Moderate", or "Severe" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "None" at Week 8.
Aggravation of Heartburn at Week 8 by Patient Diaries
Time frame: 8 weeks
The aggravation of heartburn was assessed by the intensity of the symptom at Week 8. Patients who recognized aggravation of heartburn were defined as those who selected "None" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "Mild", "Moderate" or "Severe" at Week 8.
Aggravation of Epigastric Pain at Week 8 by Patient Diaries
Time frame: 8 weeks
The aggravation of epigastric pain was assessed by the intensity of the symptom at Week 8. Patients who recognized aggravation of epigastric pain were defined as those who selected "None" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "Mild", "Moderate" or "Severe" at Week 8.
Aggravation of Upper Abdominal Discomfort at Week 8 by Patient Diaries
Time frame: 8 weeks
The aggravation of upper abdominal discomfort was assessed by the intensity of the symptom at Week 8. Patients who recognized aggravation of upper abdominal discomfort were defined as those who selected "None" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "Mild", "Moderate" or "Severe" at Week 8.
Aggravation of Regurgitation at Week 8 by Patient Diaries
Time frame: 8 weeks
The aggravation of regurgitation was assessed by the intensity of the symptom at Week 8. Patients who recognized aggravation of regurgitation were defined as those who selected "None" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "Mild", "Moderate" or "Severe" at Week 8.
Disappearance of Heartburn at Week 8 by Investigators
Time frame: 8 weeks
The investigators assessed the presence/absence and the intensity of heartburn at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized disappearance of heartburn were defined as those who had a heartburn at pre-dose and did not have the corresponding symptoms at Week 8 judged by investigators.
Disappearance of Epigastric Pain at Week 8 by Investigators
Time frame: 8 weeks
The investigators assessed the presence/absence and the intensity of epigastric pain at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized disappearance of epigastric pain were defined as those who had an epigastric pain at pre-dose and did not have the corresponding symptoms at Week 8 judged by investigators.
Disappearance of Upper Abdominal Discomfort at Week 8 by Investigators
Time frame: 8 weeks
The investigators assessed the presence/absence and the intensity of upper abdominal discomfort at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized disappearance of upper abdominal discomfort were defined as those who had an upper abdominal discomfort at pre-dose and did not have the corresponding symptoms at Week 8 judged by investigators.
Disappearance of Regurgitation at Week 8 by Investigators
Time frame: 8 weeks
The investigators assessed the presence/absence and the intensity of regurgitation at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized disappearance of regurgitation were defined as those who had a regurgitation at pre-dose and did not have the corresponding symptoms at Week 8 judged by investigators.
Aggravation of Heartburn at Week 8 by Investigators
Time frame: 8 weeks
The investigators assessed the presence/absence and the intensity of heartburn at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized aggravation of heartburn were defined as those who had no heartburn at pre-dose and did have any of the corresponding symptoms at Week 8 judged by investigators.
Aggravation of Epigastric Pain at Week 8 by Investigators
Time frame: 8 weeks
The investigators assessed the presence/absence and the intensity of epigastric pain at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized aggravation of epigastric pain were defined as those who had no epigastric pain at pre-dose and did have any of the corresponding symptoms at Week 8 judged by investigators.
Aggravation of Upper Abdominal Discomfort at Week 8 by Investigators
Time frame: 8 weeks
The investigators assessed the presence/absence and the intensity of upper abdominal discomfort at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized aggravation of upper abdominal discomfort were defined as those who had no upper abdominal discomfort at pre-dose and did have any of the corresponding symptoms at Week 8 judged by investigators.
Aggravation of Regurgitation at Week 8 by Investigators
Time frame: 8 weeks
The investigators assessed the presence/absence and the intensity of regurgitation at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized aggravation of regurgitation were defined as those who had no regurgitation at pre-dose and did have any of the corresponding symptoms at Week 8 judged by investigators.

7 secondary outcomes

Area Under the Plasma Concentration-time Curve During a Dosing Interval (AUCtau) of Esomeprazole After at Least 5 Days of Repeated Dose
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose
AUC From Time Zero to Time of Last Quantifiable Concentration (AUC0-t) of Esomeprazole After at Least 5 Days of Repeated Dose
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose
Maximum Plasma Concentration (Cmax) of Esomeprazole After at Least 5 Days of Repeated Dose
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose
Time to Reach Maximum Plasma Concentration (Tmax) of Esomeprazole After at Least 5 Days of Repeated Dose
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose
Elimination Half-life (t1/2) of Esomeprazole After at Least 5 Days of Repeated Dose
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose
Apparent Total Clearance (CL/F) of Esomeprazole After at Least 5 Days of Repeated Dose
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose
Apparent Volume of Distribution (Vz/F) of Esomeprazole After at Least 5 Days of Repeated Dose
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose

Results and safety

Results posted to the registry on 19 Jan 2017, 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	10	9
Group 2	10	10
Group 3	10	9
Group 4	10	9
Group 5	10	10

Primary outcome: Disappearance of Heartburn at Week 8 by Patient Diaries

Time frame: 8 weeks. Number. Unit: Participants

Measure	Group 1 n = 2	Group 2 n = 3	Group 3 n = 1	Group 4 n = 1	Group 5 n = 4
Value	2	0	0	1	3

Population analysed: Participants who had heartburn at pre-dose in patient diary and obtained available diary data at Week 8.

Primary outcome: Disappearance of Epigastric Pain at Week 8 by Patient Diaries

Time frame: 8 weeks. Number. Unit: Participants

Measure	Group 1 n = 2	Group 2 n = 6	Group 3 n = 5	Group 4 n = 4	Group 5 n = 7
Value	2	3	5	1	3

Population analysed: Participants who had epigastric pain at pre-dose in patient diary and obtained available diary data at Week 8.

Primary outcome: Disappearance of Upper Abdominal Discomfort at Week 8 by Patient Diaries

Time frame: 8 weeks. Number. Unit: Participants

Measure	Group 1 n = 3	Group 2 n = 6	Group 3 n = 4	Group 4 n = 4	Group 5 n = 6
Value	3	2	4	2	2

Population analysed: Participants who had upper abdominal discomfort at pre-dose in patient diary and obtained available diary data at Week 8.

Primary outcome: Disappearance of Regurgitation at Week 8 by Patient Diaries

Time frame: 8 weeks. Number. Unit: Participants

Measure	Group 1 n = 4	Group 2 n = 3	Group 3 n = 5	Group 4 n = 3	Group 5 n = 4
Value	3	2	3	2	4

Population analysed: Participants who had regurgitation at pre-dose in patient diary and obtained available diary data at Week 8.

7 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 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1	2 of 10 (20%)	8 of 10 (80%)	Not reported
Group 2	0 of 10 (0%)	8 of 10 (80%)	Not reported
Group 3	0 of 10 (0%)	5 of 10 (50%)	Not reported
Group 4	0 of 10 (0%)	5 of 10 (50%)	Not reported
Group 5	1 of 10 (10%)	6 of 10 (60%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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.

The record lists no contact. Use the official record to reach the sponsor.

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 sachet 10 mg, D961H capsule 10mg and D961H capsule 20 mg in people with Gastric Ulcer (GU) and Duodenal Ulcer (DU), 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 3 inclusion and 6 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 19 Jan 2017. 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 19 Jan 2017). 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?

Disappearance of Heartburn at Week 8 by Patient Diaries (time frame: 8 weeks). The study lists 16 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 NCT02153398.

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 19 Jan 2017.