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Gastroesophageal Reflux Disease (GERD)Phase 3NCT00658632

Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Mild to Moderate 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 85 sites in United States.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study is to investigate the efficacy and safety of Rabeprazole (RAB) Extended-Release (ER) 50 mg versus Esomeprazole (ESO) 40 mg in subjects with erosive gastroesophageal reflux disease (eGERD). 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
1,397 participants
Where
85 sitesUnited States
Study dates
Feb 2008to Sep 2009
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 gastroesophageal reflux disease (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 A or B 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

85 sites in 1 country.

85 sites in 1 country

United States85 sites

  • Study site

    Albuquerque, New Mexico, 87106

  • Study site

    Anaheim, California, 92801

  • Study site

    Anderson, South Carolina, 29621

  • Study site

    Annapolis, Maryland, 21401

  • Study site

    Baton Rouge, Louisiana, 70809

  • Study site

    Bay Shore, New York, 11706

  • Study site

    Beaumont, Texas, 77701

  • Study site

    Bellevue, Washington, 98004

  • Study site

    Boone, North Carolina, 28607

  • Study site

    Boynton Beach, Florida, 33426

  • Study site

    Bristol, Connecticut, 6010

  • Study site

    Bryan, Texas, 77802

  • Study site

    Chapel Hill, North Carolina, 27599

  • Study site

    Charleston, South Carolina, 29414

  • Study site

    Charlotte, North Carolina, 28209

  • Study site

    Chesapeake, Virginia, 23320

  • Study site

    Chula Vista, California, 91910

  • Study site

    Clive, Iowa, 50325

  • Study site

    Columbia, South Carolina, 29203

  • Study site

    Dallas, Texas, 75231

  • Study site

    Dayton, Ohio, 45415

  • Study site

    Fargo, North Dakota, 58104

  • Study site

    Fort Worth, Texas, 76104

  • Study site

    Franklin, Tennessee, 37067

  • Study site

    Fullerton, California, 92835

  • Study site

    Germantown, Tennessee, 38138

  • Study site

    Hagerstown, Maryland, 21742

  • Study site

    Hartford, Connecticut, 6102

  • Study site

    Hartsdale, New York, 10530

  • Study site

    Hialeah, Florida, 33010

  • Study site

    Hollywood, Florida, 33021

  • Study site

    Houston, Texas, 77079

  • Study site

    Huntsville, Alabama, 35801

  • Study site

    Irvine, California, 92618

  • Study site

    Jackson, Tennessee, 38301

  • Study site

    Jacksonville, Florida, 32256

  • Study site

    Jacksonville, North Carolina, 28546

  • Study site

    Johnson City, Tennessee, 37604

  • Study site

    Jupiter, Florida, 33458

  • Study site

    Kansas City, Kansas, 66160

  • Study site

    Kingsport, Tennessee, 37660

  • Study site

    Laguna Hills, California, 92653

  • Study site

    Largo, Florida, 33777

  • Study site

    Lauderdale Lakes, Florida, 33319

  • Study site

    Little Rock, Arkansas, 72205

  • Study site

    Louisville, Kentucky, 40202

  • Study site

    Louisville, Kentucky, 40291

  • Study site

    Madison, Wisconsin, 53715

  • Study site

    Mexico, Missouri, 65265

  • Study site

    Milwaukee, Wisconsin, 53209

  • Study site

    Milwaukee, Wisconsin, 53215

  • Study site

    Mineola, New York, 11501

  • Study site

    Mission Hills, California, 91345

  • Study site

    Naples, Florida, 34102

  • Study site

    Nashville, Tennessee, 37203

  • Study site

    Nashville, Tennessee, 37211

  • Study site

    New Bern, North Carolina, 28562

  • Study site

    New York, New York, 10021

  • Study site

    Newnan, Georgia, 30263

  • Study site

    Orlando, Florida, 32806

  • Study site

    Pittsford, New York, 14534

  • Study site

    Portland, Oregon, 97210

  • Study site

    Portland, Oregon, 97220

  • Study site

    Portland, Oregon, 97225

  • Study site

    Pueblo, Colorado, 81008

  • Study site

    Redwood City, California, 94062

  • Study site

    Rockford, Illinois, 61107

  • Study site

    San Antonio, Texas, 78229

  • Study site

    San Diego, California, 92123

  • Study site

    San Louis Obispo, California, 93405

  • Study site

    Sherwood, Arkansas, 72120

  • Study site

    Slidell, Louisiana, 70458

  • Study site

    Spokane, Washington, 92204-2318

  • Study site

    Spokane, Washington, 99216

  • Study site

    Tampa, Florida, 33607

  • Study site

    Tampa, Florida, 33613

  • Study site

    Tampa, Florida, 33618

  • Study site

    Topeka, Kansas, 66606

  • Study site

    Tucson, Arizona, 85712

  • Study site

    Tucson, Arizona, 85741

  • Study site

    Vineland, New Jersey, 8360

  • Study site

    Washington, Missouri, 63090

  • Study site

    West Covina, California, 91790

  • Study site

    Wheat Ridge, Colorado, 80033

  • Study site

    Wilmington, North Carolina, 28401

Other trials in United States

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 Mild to Moderate Erosive Gastroesophageal Reflux Disease (GERD)

The purpose of this study is to investigate the efficacy and safety of Rabeprazole (RAB) Extended-Release (ER) 50 mg versus Esomeprazole (ESO) 40 mg in subjects with erosive gastroesophageal reflux disease (eGERD).

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 Extended-Release (RAB ER) 50 mg or Esomeprazole (ESO) 40 mg for the treatment of mild to moderate erosive 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, once daily for 4-8 weeks.

  • EsomeprazoleDrug

    Esomeprazole 40 mg capsule, once daily for 4-8 weeks.

Study groups in NCT00658632
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: Rabeprazole sodium
2Active comparatorNot described
Receives: Drug: Esomeprazole

What is being measured

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

  1. 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 A or B 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 5mm in maximum length. Grade B: One or more mucosal breaks more than 5mm 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

  2. 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 A or B 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 5mm in maximum length. Grade B: One or more mucosal breaks more than 5mm 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 4

Secondary outcomes (1)

  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 heartburn 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.

  1. First posted15 Apr 2008 (estimated)
  2. Study startFeb 2008
  3. Primary completionApr 2009
  4. Study completionSep 2009

Resources

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
1,397 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00658632
Sponsor's protocol ID
E3810-G000-303
Status last verified
Mar 2016
First submitted
9 Apr 2008
Last updated
4 May 2016

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 85 sites in United States.

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 4 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 85 sites in United States. 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 NCT00658632.

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 May 2016.

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