Gastroesophageal Reflux Disease (GERD)Phase 3NCT00658528
Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Moderate to Severe Erosive Gastroesophageal Reflux Disease (GERD)
A Phase 3 study testing Rabeprazole sodium and Esomeprazole in people with Gastroesophageal Reflux Disease (GERD), run by Eisai Inc. at 88 sites in 13 countries.
Trial summary
The purpose of this study is to determine the safety and efficacy of Rabeprazole extended release (ER) 50 mg versus Esomeprazole 40 mg for healing and symptomatic relief among subjects with erosive gastroesophageal reflux disease (GERD). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastroesophageal Reflux Disease (GERD)
- What is being tested?
- Rabeprazole sodium and Esomeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,061 participants
- Where
- 88 sitesin 13 countries
- Study dates
- Feb 2008to Jan 2010
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, ages 18 to 75 years.
- History of GERD symptoms for at least 3 months immediately before screening.
- Heartburn for at least 2 days a week for at least 1 month before screening.
- Esophageal erosions of Los Angeles (LA) grades C or D based on EGD taken within 14 days prior to enrollment.
- Subjects who are H. pylori negative based on a screening test.
- Females should be either of non-childbearing potential or of childbearing potential. Females of childbearing potential must have negative pregnancy tests prior to randomization. Female subjects of childbearing potential must agree to use medically acceptable methods of contraception.
- Subjects must be able to read, write, and understand the language of the symptom diary.
Who cannot join
- Current or a history of esophageal motility disorders.
- Current or a history of Barrett's esophagus. Current esophageal strictures or esophagitis (known or suspected to be due to etiology other than GERD such as infection or medications).
- Current or a history of Zollinger-Ellison syndrome and other acid hypersecretory conditions, or current gastric or duodenal ulcer.
- Current or a history of cancer, with the exception of fully excised skin basal cell carcinoma.
- Inflammatory bowel disease.
- Unstable diabetes mellitus.
- History of esophageal, gastric and duodenal surgery except simple suturing of an ulcer.
- Subjects who require daily use of nonsteroidal anti-inflammatory drugs (NSAIDs), oral steroids (->;= 20 mg/day prednisone or equivalent), or aspirin (->; 325 mg/day).
Trial locations and contacts
88 sites in 13 countries.
88 sites in 13 countries
India20 sites
Study site
Ahmedabad, Gujarat, 380006
Study site
Bhopal, Madhya Pradesh, 462038
Study site
Chhatrapati Sambhajinagar, Maharashtra, 431005
Study site
Jaipur, Rajasthan, 302001
Study site
Jaipur, Rajasthan, 302004
Study site
Lucknow, Uttar Pradesh, 226003
Study site
Ludhiana, Punjab, 141008
Study site
Manipal, Karnataka, 576104
Study site
Mumbai, Maharashtra, 400 022
Study site
Mumbai, Maharashtra, 400012
Study site
Mumbai, Maharashtra, 400016
Study site
Mumbai, Maharashtra, 400020
Study site
Nagpur, Maharashtra, 440012
Study site
New Delhi, National Capital Territory of Delhi, 110 060
Study site
New Delhi, National Capital Territory of Delhi, 110002
Study site
New Delhi, National Capital Territory of Delhi, 110017
Study site
Pune, Maharashtra, 411001
Study site
Pune, Maharashtra, 411004
Study site
Pune, Maharashtra, PUNE-411013
Study site
Thane, Maharashtra, 400001
Canada13 sites
Study site
Guelph, Ontario, N1H 3R3
Study site
Hamilton, Ontario, L8N 3Z5
Study site
Montreal, Quebec, H1T 2M4
Study site
Montreal, Quebec, H3A 1A1
Study site
Newmarket, Ontario, L3Y 5G8
Study site
Pointe-Claire, Quebec, H9R 3J1
Study site
Québec, Quebec, G1L 3L5
Study site
Québec, Quebec, G1R 2J6
Study site
Saint John, New Brunswick, E2K 1J5
Study site
Saskatoon, Saskatchewan, S7K 1J5
Study site
St. John's, Newfoundland and Labrador, A1A 3R5
Study site
Toronto, Ontario, M6H 3M1
Study site
Windsor, Ontario, N8W 1E6
Germany11 sites
Study site
Berlin, State of Berlin, 10967
Study site
Berlin, State of Berlin, 13509
Study site
Dietzenbach, Hesse, 63128
Study site
Dortmund, North Rhine-Westphalia, 44137
Study site
Hamburg, Free and Hanseatic City of Hamburg, 22143
Study site
Lienen/Kattenve Nne, North Rhine-Westphalia, 49536
Study site
Mannheim, Baden-Wurttemberg, 68167
Study site
Marburg, Hesse, 35033
Study site
Munich, Bavaria, 81669
Study site
Münster, North Rhine-Westphalia, 48159
Study site
Wiesbaden, Hesse, 65185
Argentina9 sites
Study site
Capital Federal, CBA, C1425DND
Study site
Isidro Casanova, La Matanza, BUE, 1765
Study site
Mendoza, MEN, 5500
Study site
Ramos Mejía, BUE, 1221
Study site
Rosario, SFE, S2000BLG
Study site
Rosario, SFE, S2000CRF
Study site
Rosario, SFE, S2000CVB
Study site
San Isidro, BUE, B1642BHH
Study site
San Juan, SJN, 5447
Hungary9 sites
Study site
Budapest, Hungary, 1036
Study site
Dunaújváros, Hungary, 2400
Study site
Kisbér, Hungary, 2870
Study site
Miskolc, Hungary, 3530
Study site
Nagykanizsa, Hungary, 8800
Study site
Nyíregyháza, Hungary, 4400
Study site
Szentes, Hungary, 6600
Study site
Veszprém, Hungary, 8200
Study site
Zalaegerszeg, Hungary, 8900
Bulgaria7 sites
Study site
Plovdiv, Bulgaria, 4000
Study site
Sofia, Bulgaria, 1233
Study site
Sofia, Bulgaria, 1407
Study site
Sofia, Bulgaria, 1431
Study site
Sofia, Bulgaria, 1709
Study site
Stara Zagora, Bulgaria, 6000
Study site
Varna, Bulgaria, 9010
Australia6 sites
Study site
Box Hill, Victoria, 3128
Study site
Carina Heights, Queensland, 4152
Study site
Five Dock, New South Wales, 2046
Study site
Frankston, Victoria, 3199
Study site
Kippa-Ring, Queensland, 4021
Study site
Malvern, Victoria, 3144
France5 sites
Study site
Dieppe, France, 76200
Study site
La Chaussée-Saint-Victor, France, 41260
Study site
Lyon, France, 69437
Study site
Marseille 13, France, 13009
Study site
Nice, France, 6100
Croatia2 sites
Study site
Rijeka, Croatia, 51 000
Study site
Zagreb, Croatia, 10 000
About this study
Official title: A Randomized Double-Blind Parallel Study of Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Moderate to Severe Erosive Gastroesophageal Reflux Disease (GERD)
The purpose of this study is to determine the safety and efficacy of Rabeprazole extended release (ER) 50 mg versus Esomeprazole 40 mg for healing and symptomatic relief among subjects with erosive gastroesophageal reflux disease (GERD).
Read the detailed description
This is a multicenter, randomized, double-blind, double-dummy, parallel-group study. Subjects who meet all the inclusion/exclusion criteria will be randomly assigned to 1 of 2 treatment groups, Rabeprazole ER 50 mg or Esomeprazole 40 mg for the treatment of moderate to severe erosive GERD.
- Conditions
- Gastroesophageal Reflux Disease (GERD)
- Being tested
- Rabeprazole sodium, Esomeprazole
- Keywords
- GERD, erosive GERD, erosive esophagitis
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rabeprazole sodiumDrug
Also called Aciphex
Rabeprazole ER 50 mg capsule, taken orally, once daily for 4-8 weeks.
EsomeprazoleDrug
Esomeprazole 40 mg capsule, taken orally, once daily for 4-8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Rabeprazole sodium |
| 2 | Active comparator | Not described Receives: Drug: Esomeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Erosive Gastroesophageal Reflux Disease (eGERD) Who Achieved Endoscopically-confirmed Healing by 8 Weeks
Healing at week 4 or 8 were based on improvement of eGERD of the Los Angeles (LA) classification of esophagitis Grade C or D from Baseline. Classifications include:
Not Present: No breaks (erosions) in the esophageal mucosa (however, edema, erythema, or friability may be present).
Grade A: One or more mucosal breaks not more than 5 mm in maximum length. Grade B: One or more mucosal breaks more than 5 mm in maximum length, but not continuous between the tops of 2 mucosal folds.
Grade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference.
Gread D: Mucosal breaks involving at least 75% of the esophageal circumference.
Measured: Baseline and Week 8
Percentage of Participants With eGERD Who Achieved Endoscopically-confirmed Healing by 4 Weeks
Healing at week 4 or 8 were based on improvement of eGERD of the LA classification of esophagitis Grade C or D from Baseline. Classifications include:
Not Present: No breaks (erosions) in the esophageal mucosa (however, edema, erythema, or friability may be present).
Grade A: One or more mucosal breaks not more than 5 mm in maximum length. Grade B: One or more mucosal breaks more than 5 mm in maximum length, but not continuous between the tops of 2 mucosal folds.
Grade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference.
Grade D: Mucosal breaks involving at least 75% of the esophageal circumference.
Measured: Baseline and Week 4
Secondary outcomes (1)
Percentage of Participants Who Achieved Diary-recorded Sustained Resolution of Heartburn by Week 4
During the first 4 weeks of the Double-blind Phase, participants were to record heartburn in a daily diary. Participant daily symptoms for the assessment of hearburn was based on a commonly used 4-point Likert scale of none, mild, moderate and severe. A participant was considered achieving sustained resolution of heartburn if the participant had maintained at least 7 consecutive heartburn-free days.
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2008 (estimated)
- Study startFeb 2008
- Primary completionSep 2009
- Study completionJan 2010
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Reflux Disease (GERD)Studies of the same condition, open and under way.
- More trials run by Eisai Inc.The 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,061 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yufang Lu, MD, PhD, Study director, Eisai Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00658528
- Sponsor's protocol ID
- E3810-G000-301
- Other IDs
- 2007-005570-32
- Status last verified
- Nov 2015
- First submitted
- 9 Apr 2008
- Last updated
- 21 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Laine L, Katz PO, Johnson DA, Ibegbu I, Goldstein MJ, Chou C, Rossiter G, Lu Y. Randomised clinical trial: a novel rabeprazole extended release 50 mg formulation vs. esomeprazole 40 mg in healing of moderate-to-severe erosive oesophagitis - the results of two double-blind studies. Aliment Pharmacol Ther. 2011 Jan;33(2):203-12. doi: 10.1111/j.1365-2036.2010.04516.x. Epub 2010 Nov 30.
PubMed 21114792
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-Blind Parallel Study of Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Moderate to Severe Erosive Gastroesophageal Reflux Disease (GERD)
- ClinicalTrials.gov ID
- NCT00658528
- Acronym / sponsor ID
- E3810-G000-301
- Conditions
- Gastroesophageal Reflux Disease (GERD)
- Keywords
- GERD, erosive GERD, erosive esophagitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,061 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 15 Apr 2008 (estimated)
- Results
- Posted 23 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety and efficacy of Rabeprazole extended release (ER) 50 mg versus Esomeprazole 40 mg for healing and symptomatic relief among subjects with erosive gastroesophageal reflux disease (GERD).
Detailed description
This is a multicenter, randomized, double-blind, double-dummy, parallel-group study. Subjects who meet all the inclusion/exclusion criteria will be randomly assigned to 1 of 2 treatment groups, Rabeprazole ER 50 mg or Esomeprazole 40 mg for the treatment of moderate to severe erosive GERD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Rabeprazole sodium |
| 2 | Active comparator | Drug: Esomeprazole |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female, ages 18 to 75 years.
- History of GERD symptoms for at least 3 months immediately before screening.
- Heartburn for at least 2 days a week for at least 1 month before screening.
- Esophageal erosions of Los Angeles (LA) grades C or D based on EGD taken within 14 days prior to enrollment.
- Subjects who are H. pylori negative based on a screening test.
Key exclusion criteria (8 listed)
- Current or a history of esophageal motility disorders.
- Current or a history of Barrett's esophagus. Current esophageal strictures or esophagitis (known or suspected to be due to etiology other than GERD such as infection or medications).
- Current or a history of Zollinger-Ellison syndrome and other acid hypersecretory conditions, or current gastric or duodenal ulcer.
- Current or a history of cancer, with the exception of fully excised skin basal cell carcinoma.
- Inflammatory bowel disease.
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 |
|---|---|---|
| Rabeprazole sodiumAlso: AciphexRabeprazole ER 50 mg capsule, taken orally, once daily for 4-8 weeks. | Drug | 1 |
| EsomeprazoleEsomeprazole 40 mg capsule, taken orally, once daily for 4-8 weeks. | Drug | 2 |
Primary outcome
Percentage of Participants With Erosive Gastroesophageal Reflux Disease (eGERD) Who Achieved Endoscopically-confirmed Healing by 8 Weeks
Time frame: Baseline and Week 8
Healing at week 4 or 8 were based on improvement of eGERD of the Los Angeles (LA) classification of esophagitis Grade C or D from Baseline. Classifications include: Not Present: No breaks (erosions) in the esophageal mucosa (however, edema, erythema, or friability may be present). Grade A: One or more mucosal breaks not more than 5 mm in maximum length. Grade B: One or more mucosal breaks more than 5 mm in maximum length, but not continuous between the tops of 2 mucosal folds. Grade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference. Gread D: Mucosal breaks involving at least 75% of the esophageal circumference.
Percentage of Participants With eGERD Who Achieved Endoscopically-confirmed Healing by 4 Weeks
Time frame: Baseline and Week 4
Healing at week 4 or 8 were based on improvement of eGERD of the LA classification of esophagitis Grade C or D from Baseline. Classifications include: Not Present: No breaks (erosions) in the esophageal mucosa (however, edema, erythema, or friability may be present). Grade A: One or more mucosal breaks not more than 5 mm in maximum length. Grade B: One or more mucosal breaks more than 5 mm in maximum length, but not continuous between the tops of 2 mucosal folds. Grade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference. Grade D: Mucosal breaks involving at least 75% of the esophageal circumference.
1 secondary outcome
Percentage of Participants Who Achieved Diary-recorded Sustained Resolution of Heartburn by Week 4
Time frame: Week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21114792Laine L, Katz PO, Johnson DA, Ibegbu I, Goldstein MJ, Chou C, Rossiter G, Lu Y. Randomised clinical trial: a novel rabeprazole extended release 50 mg formulation vs. esomeprazole 40 mg in healing of moderate-to-severe erosive oesophagitis - the results of two double-blind studies. Aliment Pharmacol Ther. 2011 Jan;33(2):203-12. doi: 10.1111/j.1365-2036.2010.04516.x. Epub 2010 Nov 30.
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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.
Yufang Lu, MD, PhD study director
Eisai Inc.
88 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rabeprazole sodium and Esomeprazole in people with Gastroesophageal Reflux Disease (GERD), run by Eisai Inc. at 88 sites in 13 countries.
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 7 inclusion and 8 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 21 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 88 sites in India, Canada, Germany, Argentina, Hungary and 8 more countries. 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 23 Jun 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 Erosive Gastroesophageal Reflux Disease (eGERD) Who Achieved Endoscopically-confirmed Healing by 8 Weeks (time frame: Baseline and Week 8). The study lists 2 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 NCT00658528, which also lists 1 linked publication.
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 21 Dec 2015.