Refractory Reflux EsophagitisPhase 3NCT01669811

Compare D961H 20 mg Bid and 20 mg qd in Patients With Refractory Reflux Esophagitis (Inflammation of Lower Esophagus)

A Phase 3 study testing Esomeprazole (D961H) twice daily and Esomeprazole (D961H) once daily in people with Refractory Reflux Esophagitis, run by AstraZeneca at 63 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 a phase 3 multicentre, randomised, double-blind, parallel-group, comparative study to evaluate the efficacy of esomeprazole (D961H) 20 mg twice daily and esomeprazole (D961H) 20 mg once daily in patients (in the form of esomeprazole magnesium salt) with refractory reflux esophagitis after 8 weeks of standard… Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Refractory Reflux Esophagitis
What is being tested?: Esomeprazole (D961H) twice daily and Esomeprazole (D961H) once daily
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,398 participants
Where: 63 sitesJapan
Study dates: Aug 2012to May 2014
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 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Provision of informed consent prior to any study specific procedures.
Patients with RE classified into LA classification Grade A, B, C or D by Endoscopy despite of at least 8-week treatment using standard doses of PPIs.
Patients must fulfill at least one of the following criteria such as (i) RE with LA grade C/D at Endoscopy on visit 1 and/or history of RE with LA grade C/D, (ii) RE was diagnosed more than 1 year before visit 1.
Patients who are able to complete the Patient Diary

Who cannot join

Male or female aged less than 20 years at the time of informed consent.
Patients with current evidence of the gastrointestinal diseases/conditions such as esophageal stricture to interfere with the evaluation of the study etc
Gastric or duodenal ulcer verified by Endoscopy within 12 weeks before randomisation.
Previous esophageal, gastric or duodenal surgery except simple closure of perforated ulcer, simple endoscopic treatment with simple operation etc
Current or historical evidence (within 12 weeks prior to randomisation) of the diseases/conditions as judged to interfere with the evaluation of the study.

Trial locations and contacts

63 sites in 1 country.

City, postcode or hospital

63 sites in 1 country

Japan63 sites

Research Site
Abiko-shi
Research Site
Adachi-ku
Research Site
Annaka-shi
Research Site
Asahikawa-shi
Research Site
Asakura-shi
Research Site
Beppu-shi
Research Site
Bunkyō City
Research Site
Chūōku
Research Site
Fujiidera-shi
Research Site
Fukuoka
Research Site
Fukushima
Research Site
Gifu
Research Site
Hamamatsu
Research Site
Hirakata-shi
Research Site
Hitachi-shi
Research Site
Ibara-shi
Research Site
Ichiki-Kushikino-shi
Research Site
Ishikari-shi
Research Site
Iwata-shi
Research Site
Izumo-shi
Research Site
Kagoshima
Research Site
Kamakura-shi
Research Site
Kanazawa
Research Site
Karatsu-shi
Research Site
Kawasaki-shi
Research Site
Kirishima-shi
Research Site
Kita-ku
Research Site
Kobe
Research Site
Kochi
Research Site
Koga-shi
Research Site
Koriyama-shi
Research Site
Kumagaya-shi
Research Site
Kumamoto
Research Site
Kyoto
Research Site
Machida-shi
Research Site
Matsumoto-shi
Research Site
Meguro-ku
Research Site
Moriguchi-shi
Research Site
Nishinomiya-shi
Research Site
Ogori-shi
Research Site
Ōita
Research Site
Okayama
Research Site
Osaka
Research Site
Ōta-ku
Research Site
Otawara-shi
Research Site
Saga
Research Site
Saitama-shi
Research Site
Sakaide-shi
Research Site
Sakushu
Research Site
Sapporo
Research Site
Sendai
Research Site
Shibuya-ku
Research Site
Shinagawa-ku
Research Site
Shinjuku-ku
Research Site
Takasaki-shi
Research Site
Takatsuki-shi
Research Site
Toshima-ku
Research Site
Toyama
Research Site
Uji-shi
Research Site
Wakayama
Research Site
Yanagawa-shi
Research Site
Yokohama
Research Site
Yufu-shi

Other trials in Japan

About this study

Official title: A Multicentre, Randomised, Double-blind, Parallel-group, Comparative Study to Compare the Efficacy and Safety of D961H 20 mg Twice Daily Oral Administration and D961H 20 mg Once Daily Oral Administration in Patients With Refractory Reflux Esophagitis

Read the detailed description

A multicentre, randomised, double-blind, parallel-group, comparative study to compare the efficacy and safety of D961H 20 mg twice daily oral administration and D961H 20 mg once daily oral administration in patients with refractory reflux esophagitis

Conditions: Refractory Reflux Esophagitis
Being tested: Esomeprazole (D961H) twice daily, Esomeprazole (D961H) once daily
Keywords: Refractory Reflux Esophagitis,, Japanese,, Nexium,, twice daily,, oral administration
Medical subject headings: Esophagitis, Peptic

What participants receive

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

Esomeprazole (D961H) twice dailyDrug
One capsule of esomeprazole 20 mg (in the form of esomeprazole magnesium salt) will be administered in the morning and in the evening
Esomeprazole (D961H) once dailyDrug
One capsule of esomeprazole 20 mg (in the form of esomeprazole magnesium salt) will be administered in the morning and one corresponding placebo capsule in the evening

Study groups in NCT01669811
Study group	Role	What they receive
D961H 20mg twice daily	Experimental	Double-blinded Receives: Drug: Esomeprazole (D961H) twice daily
D961H 20mg once daily	Active comparator	Double-blinded Receives: Drug: Esomeprazole (D961H) once daily

What is being measured

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

Percentage of Participants With Healing of RE Who Were Graded "O" at Week 8 Out of Participants Who Were Graded "A" to "D" at Baseline According to Los Angeles Classification
Percentage of participants with healing of reflux esophagitis (RE) who were graded "O" (No RE) at Week 8 out of participants who were graded "A" (least severe) to "D" (most severe) at baseline according to Los Angeles classification
Measured: 8 Weeks

Secondary outcomes (6)

Percentage of Participants With Healing of RE Who Were Graded "O" at Week 4 Out of Participants Who Were Graded "A" to "D" at Baseline According to Los Angeles Classification
Percentage of participants with healing of reflux esophagitis (RE) who were graded "O" (No RE) at Week 4 out of participants who were graded "A" (least severe) to "D" (most severe) at baseline according to Los Angeles classification
Measured: 4 Weeks
Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Heartburn at Week 4
Cumulative percentage of participants who had sustained resolution (defined as at least 7-day consecutive symptom free) of gastroesophageal reflux disease (GERD) symptom -heartburn at Week 4 (on Day 29) based on the Kaplan-Meier method.
Measured: 4 Weeks
Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Acid Regurgitation at Week 4
Cumulative percentage of participants who had sustained resolution (defined as at least 7-day consecutive symptom free) of gastroesophageal reflux disease (GERD) symptom -acid regurgitation at Week 4 (on Day 29) based on the Kaplan-Meier method.
Measured: 4 Weeks
Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Abdominal Pain at Week 4
Cumulative percentage of participants who had sustained resolution (defined as at least 7-day consecutive symptom free) of gastroesophageal reflux disease (GERD) symptom -abdominal pain at Week 4 (on Day 29) based on the Kaplan-Meier method.
Measured: 4 Weeks
Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Difficulty of Swallowing at Week 4
Cumulative percentage of participants who had sustained resolution (defined as at least 7-day consecutive symptom free) of gastroesophageal reflux disease (GERD) symptom -difficulty of swallowing at Week 4 (on Day 29) based on the Kaplan-Meier method.
Measured: 4 Weeks
Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Sleep Disturbance at Week 4
Cumulative percentage of participants who had sustained resolution (defined as at least 7-day consecutive symptom free) of gastroesophageal reflux disease (GERD) symptom -sleep disturbance at Week 4 (on Day 29) based on the Kaplan-Meier method.
Measured: 4 Weeks

Timeline

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

Aug 2012May 2014

First posted21 Aug 2012 (estimated)
Study startAug 2012
Primary completionMay 2014
Study completionMay 2014

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 Refractory 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,398 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01669811
Sponsor's protocol ID: D961UC00002
Status last verified: Aug 2015
First submitted: 17 Aug 2012
Last updated: 27 Aug 2015
Results posted: Yes, on ClinicalTrials.gov

Study at a glance

From the registry record, last updated by the sponsor on 27 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicentre, Randomised, Double-blind, Parallel-group, Comparative Study to Compare the Efficacy and Safety of D961H 20 mg Twice Daily Oral Administration and D961H 20 mg Once Daily Oral Administration in Patients With Refractory Reflux Esophagitis
ClinicalTrials.gov ID: NCT01669811
Acronym / sponsor ID: D961UC00002
Conditions: Refractory Reflux Esophagitis
Keywords: Refractory Reflux Esophagitis,, Japanese,, Nexium,, twice daily,, oral administration
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,398 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Aug 2012
Primary completion: May 2014 (actual)
Study completion: May 2014 (actual)
First posted: 21 Aug 2012 (estimated)
Results: Posted 14 Aug 2015

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
D961H 20mg twice daily	Experimental	Drug: Esomeprazole (D961H) twice dailyDouble-blinded
D961H 20mg once daily	Active comparator	Drug: Esomeprazole (D961H) once dailyDouble-blinded

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Provision of informed consent prior to any study specific procedures.
Patients with RE classified into LA classification Grade A, B, C or D by Endoscopy despite of at least 8-week treatment using standard doses of PPIs.
Patients must fulfill at least one of the following criteria such as (i) RE with LA grade C/D at Endoscopy on visit 1 and/or history of RE with LA grade C/D, (ii) RE was diagnosed more than 1 year before visit 1.
Patients who are able to complete the Patient Diary

Key exclusion criteria (5 listed)

Male or female aged less than 20 years at the time of informed consent.
Patients with current evidence of the gastrointestinal diseases/conditions such as esophageal stricture to interfere with the evaluation of the study etc
Gastric or duodenal ulcer verified by Endoscopy within 12 weeks before randomisation.
Previous esophageal, gastric or duodenal surgery except simple closure of perforated ulcer, simple endoscopic treatment with simple operation etc
Current or historical evidence (within 12 weeks prior to randomisation) of the diseases/conditions as judged to interfere with the evaluation of the study.

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
Esomeprazole (D961H) twice dailyOne capsule of esomeprazole 20 mg (in the form of esomeprazole magnesium salt) will be administered in the morning and in the evening	Drug	D961H 20mg twice daily
Esomeprazole (D961H) once dailyOne capsule of esomeprazole 20 mg (in the form of esomeprazole magnesium salt) will be administered in the morning and one corresponding placebo capsule in the evening	Drug	D961H 20mg once daily

Primary outcome

Percentage of Participants With Healing of RE Who Were Graded "O" at Week 8 Out of Participants Who Were Graded "A" to "D" at Baseline According to Los Angeles Classification
Time frame: 8 Weeks
Percentage of participants with healing of reflux esophagitis (RE) who were graded "O" (No RE) at Week 8 out of participants who were graded "A" (least severe) to "D" (most severe) at baseline according to Los Angeles classification

6 secondary outcomes

Percentage of Participants With Healing of RE Who Were Graded "O" at Week 4 Out of Participants Who Were Graded "A" to "D" at Baseline According to Los Angeles Classification
Time frame: 4 Weeks
Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Heartburn at Week 4
Time frame: 4 Weeks
Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Acid Regurgitation at Week 4
Time frame: 4 Weeks
Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Abdominal Pain at Week 4
Time frame: 4 Weeks
Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Difficulty of Swallowing at Week 4
Time frame: 4 Weeks
Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Sleep Disturbance at Week 4
Time frame: 4 Weeks

Results and safety

Results posted to the registry on 14 Aug 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
D961H 20 mg BID	145	142
D961H 20 mg QD + Placebo	142	131

Primary outcome: Percentage of Participants With Healing of RE Who Were Graded "O" at Week 8 Out of Participants Who Were Graded "A" to "D" at Baseline According to Los Angeles Classification

Time frame: 8 Weeks. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	D961H 20mg Bid n = 145	D961H 20mg QD + Placebo n = 140
Value	92.4 (86.9 to 95.7)	68.6 (60.5 to 75.7)

D961H 20mg Bid vs D961H 20mg QD + Placebo: Difference in proportions: 23.8 (95% CI 14.9 to 32.6), p <0.0001, Chi-squared

Population analysed: Included all of the randomised participants who were definitely diagnosed to have refractory RE before the randomisation and who had at least one dose of investigational product

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
D961H 20 mg BID	1 of 145 (0.7%)	8 of 145 (5.5%)	Not reported
D961H 20 mg QD + Placebo	3 of 142 (2.1%)	9 of 142 (6.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
D961UC00002\_SynopsisLink provided by the sponsor.

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.

Tore Lind, MSD study director

AstraZeneca, Moelndal, Sweden

Lan Chen study director

AstraZeneca, Osaka, Japan

Yoshikazu Kinoshita, PROFESSOR OF MEDICINE principal investigator

Dept of Gastroenterology and Hepatology, Shimane, Japan

63 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 Esomeprazole (D961H) twice daily and Esomeprazole (D961H) once daily in people with Refractory Reflux Esophagitis, run by AstraZeneca at 63 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 27 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 63 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 14 Aug 2015). 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?

Percentage of Participants With Healing of RE Who Were Graded "O" at Week 8 Out of Participants Who Were Graded "A" to "D" at Baseline According to Los Angeles Classification (time frame: 8 Weeks). 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 NCT01669811.

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 27 Aug 2015.