Reflux EsophagitisPhase 3NCT00633932

Reflux Esophagitis Phase III Study (Initial Treatment)

A Phase 3 study testing Esomeprazole and Omeprazole in people with Reflux Esophagitis, run by AstraZeneca at 41 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 study is to evaluate the efficacy of esomeprazole 20 mg once daily and 40 mg once daily for 8 weeks on healing of Reflux Esophagitis in patients with reflux esophagitis in comparison with omeprazole 20 mg once daily by assessment of presence/absence of Reflux Esophagitis at Week 8 according to the Los Angeles… Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Reflux Esophagitis
What is being tested?: Esomeprazole and Omeprazole
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 602 participants
Where: 41 sitesJapan
Study dates: Dec 2007to Dec 2008
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

Endoscopically verified Reflux Esophagitis classified into Los Angeles classification Grade A, B, C or D within 1 week before randomisation

Who cannot join

Gastric or duodenal ulcer verified by EGD within 12 weeks before randomisation.
Use of any PPI from 14 days before EGD performed at the screening visit to the day of randomisation.

Trial locations and contacts

41 sites in 1 country.

City, postcode or hospital

41 sites in 1 country

Japan41 sites

Research Site
Adachi City, Tokyo
Research Site
Akita, Akita
Research Site
Fujiidera, Osaka
Research Site
Fujisawa, Kanagawa
Research Site
Fukuoka, Fukuoka
Research Site
Gifu, Gifu
Research Site
Hachiōji, Tokyo
Research Site
Hitachi, Ibaraki
Research Site
Kashiwa, Chiba
Research Site
Kawasaki, Kanagawa
Research Site
Kisarazu, Chiba
Research Site
Kiso, Nagano
Research Site
Kiyose, Tokyo
Research Site
Kōriyama, Fukishima
Research Site
Kurume, Fukuoka
Research Site
Kyoto, Kyoto
Research Site
Maebashi, Gunma
Research Site
Matsumoto, Nagano
Research Site
Mito, Ibaraki
Research Site
Nihonmatsu, Fukishima
Research Site
Nishishirakawa, Fukishima
Research Site
Nukaya, Fukuoka
Research Site
Ohtawara, Tochigi
Research Site
Ōita, Oita Prefecture
Research Site
Sagamihara, Kanagawa
Research Site
Sakaidechō, Kagawa-ken
Research Site
Sapporo, Hokkaido
Research Site
Setagaya City, Tokyo
Research Site
Shibata, Myagi
Research Site
Shimonoseki, Yamaguchi
Research Site
Shinagawa, Tokyo
Research Site
Shirakawa, Fukushima
Research Site
Shizuoka, Shizuoka
Research Site
Sugawa, Fukushima
Research Site
Takamatsu, Kagawa-ken
Research Site
Toshima-ku, Tokayo
Research Site
Tottori-shi, Tottori
Research Site
Toyonaka, Osaka
Research Site
Tsukuba, Ibaraki
Research Site
Yasunaka, Gunma
Research Site
Yokohama, Kanagawa

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 Esomeprazole 20 mg and 40 mg Once Daily Oral Administration With Omeprazole 20 mg Once Daily Oral Administration in Patients With Reflux Esophagitis

Conditions: Reflux Esophagitis
Being tested: Esomeprazole, Omeprazole
Keywords: Reflux Esophagitis
Medical subject headings: Esophagitis, Peptic

What participants receive

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

EsomeprazoleDrug
Also called Nexium
20mg once daily
EsomeprazoleDrug
Also called Nexium
40 mg once daily
OmeprazoleDrug
Also called Prilosec
20mg once daily

Study groups in NCT00633932
Study group	Role	What they receive
1	Experimental	Esomeprazole 20mg Receives: Drug: Esomeprazole
2	Experimental	Esomeprazole 40mg Receives: Drug: Esomeprazole
3	Active comparator	Omeprazole 20mg Receives: Drug: Omeprazole

What is being measured

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

Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded "O" at Week 8 Out of Patients Who Were Graded "A, B, C or D" at Baseline According to Los Angeles Classification".
Los Angeles classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C, Grade D). The subjects who were definitely diagnosed to have RE classified into LA classification Grade A, B, C or D based on the EGD on Visit 1 were randomised. A subject classified into LA classification Grade O was considered no reflux esophagitis. The definitions of each grade are: Grade A (Mucosal break < 5 mm in length), Grade B (Mucosal break > 5mm), Grade C (Mucosal break continuous between > 2 mucosal folds) and Grade D (Mucosal break >75% of esophageal circumference).
Measured: 8 weeks

Secondary outcomes (1)

Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded "O" at Week 4 Out of Patients Who Were Graded "A, B, C or D" at Baseline According to Los Angeles Classification
Los Angeles classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). The subjects who were definitely diagnosed to have RE classified into LA classification Grade A, B, C or D based on the EGD on Visit 1 were randomised. A subject classified into LA classification Grade O was considered no reflux esophagitis. The definitions of each grade are: Grade A (Mucosal break < 5 mm in length), Grade B (Mucosal break > 5mm), Grade C (Mucosal break continuous between > 2 mucosal folds) and Grade D (Mucosal break >75% of esophageal circumference).
Measured: 4 weeks

Timeline

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

Dec 2007Dec 2008

First posted12 Mar 2008 (estimated)
Study startDec 2007
Study completionDec 2008

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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 602 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00633932
Sponsor's protocol ID: D961HC00002
Status last verified: Dec 2010
First submitted: 4 Mar 2008
Last updated: 20 Dec 2010
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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

Recruiting
SPADE Clinical Trial.
Early Gastric Cancer, Adenocarcinoma of the Stomach
Not yet recruitingPhase 4
PPI Dosing Per CYP2C19 Genotype
Gastroesophageal Reflux Disease With Esophagitis
Active, not recruitingPhase 3
Domperidone in Treating Patients With Gastrointestinal Disorders
Digestive System Disorder, Dyspepsia
RecruitingObservational study
Preoperative Predictors of Symptom Improvement After Laparoscopic Fundoplication
Gastroesophageal Reflux Disease, Hiatal Hernia
RecruitingObservational study
A Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring
Erosive Esophagitis, Heartburn

All Reflux Esophagitis trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Dec 2010. 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 Esomeprazole 20 mg and 40 mg Once Daily Oral Administration With Omeprazole 20 mg Once Daily Oral Administration in Patients With Reflux Esophagitis
ClinicalTrials.gov ID: NCT00633932
Acronym / sponsor ID: D961HC00002
Conditions: Reflux Esophagitis
Keywords: Reflux Esophagitis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 602 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Dec 2007
Study completion: Dec 2008 (actual)
First posted: 12 Mar 2008 (estimated)
Results: Posted 8 Apr 2010

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: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
1	Experimental	Drug: EsomeprazoleEsomeprazole 20mg
2	Experimental	Drug: EsomeprazoleEsomeprazole 40mg
3	Active comparator	Drug: OmeprazoleOmeprazole 20mg

Who may qualify

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

Key inclusion criteria (1 listed)

Endoscopically verified Reflux Esophagitis classified into Los Angeles classification Grade A, B, C or D within 1 week before randomisation

Key exclusion criteria (2 listed)

Gastric or duodenal ulcer verified by EGD within 12 weeks before randomisation.
Use of any PPI from 14 days before EGD performed at the screening visit to the day of randomisation.

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
EsomeprazoleAlso: Nexium20mg once daily	Drug	1
EsomeprazoleAlso: Nexium40 mg once daily	Drug	2
OmeprazoleAlso: Prilosec20mg once daily	Drug	3

Primary outcome

Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded "O" at Week 8 Out of Patients Who Were Graded "A, B, C or D" at Baseline According to Los Angeles Classification".
Time frame: 8 weeks
Los Angeles classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C, Grade D). The subjects who were definitely diagnosed to have RE classified into LA classification Grade A, B, C or D based on the EGD on Visit 1 were randomised. A subject classified into LA classification Grade O was considered no reflux esophagitis. The definitions of each grade are: Grade A (Mucosal break < 5 mm in length), Grade B (Mucosal break > 5mm), Grade C (Mucosal break continuous between > 2 mucosal folds) and Grade D (Mucosal break >75% of esophageal circumference).

1 secondary outcome

Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded "O" at Week 4 Out of Patients Who Were Graded "A, B, C or D" at Baseline According to Los Angeles Classification
Time frame: 4 weeks

Results and safety

Results posted to the registry on 8 Apr 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Experimental: Esomeprazole 40mg	191	179
Experimental: Esomeprazole 20mg	190	176
Comparator: Omeprazole 20mg	191	180

Primary outcome: Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded "O" at Week 8 Out of Patients Who Were Graded "A, B, C or D" at Baseline According to Los Angeles Classification".

Time frame: 8 weeks. Number. Unit: participants

Measure	Experimental: Esomeprazole 40mg n = 190	Experimental: Esomeprazole 20mg n = 189	Comparator: Omeprazole 20mg n = 190
Value	171	165	166

Population analysed: One participant for each treatment group did not take any investigational product. These 3 participants were excluded (1 for each treatment group) from all the efficacy and safety analyses.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Experimental: Esomeprazole 40mg	0 of 190 (0%)	12 of 190 (6.3%)	Not reported
Experimental: Esomeprazole 20mg	1 of 189 (0.5%)	9 of 189 (4.8%)	Not reported
Comparator: Omeprazole 20mg	1 of 190 (0.5%)	16 of 190 (8.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Reflux Esophagitis

Recruiting
SPADE Clinical Trial.
Early Gastric Cancer, Adenocarcinoma of the Stomach
Not yet recruitingPhase 4
PPI Dosing Per CYP2C19 Genotype
Gastroesophageal Reflux Disease With Esophagitis
Active, not recruitingPhase 3
Domperidone in Treating Patients With Gastrointestinal Disorders
Digestive System Disorder, Dyspepsia
RecruitingObservational study
Preoperative Predictors of Symptom Improvement After Laparoscopic Fundoplication
Gastroesophageal Reflux Disease, Hiatal Hernia
RecruitingObservational study
A Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring
Erosive Esophagitis, Heartburn

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.

Maotsugu Oyama, MD, PhD study director

AstraZeneca

41 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 and Omeprazole in people with Reflux Esophagitis, run by AstraZeneca at 41 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 1 inclusion and 2 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 20 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 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 8 Apr 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded "O" at Week 8 Out of Patients Who Were Graded "A, B, C or 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 NCT00633932.

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 20 Dec 2010.