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Symptomatic Gastroesophageal Reflux Disease (sGERD)Phase 3NCT00911534

Comparing the Efficacy, Safety, and Tolerability of Rabeprazole ER 50 mg With Placebo in Subjects With Symptomatic Gastroesophageal Reflux Disease (sGERD)

A Phase 3 study testing rabeprazole sodium in people with Symptomatic Gastroesophageal Reflux Disease (sGERD), run by Eisai Inc. at 98 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 compare the efficacy, safety and tolerability of rabeprazole extended release (ER) 50 mg with placebo in subjects with symptomatic gastroesophageal reflux disease (sGERD). Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
rabeprazole sodium
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
305 participants
Where
98 sitesUnited States
Study dates
Jan 2009to Oct 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 through 75 years will be included in the study. Females should be either of nonchildbearing potential or of childbearing potential. Females of childbearing potential must have negative serum and urine pregnancy tests prior to randomization. Female subjects of childbearing potential must agree to use medically acceptable methods of contraception starting at Visit 1 and throughout the entire study period and for 1 month after the last dose of study drug. Women using hormonal contraceptives must also be using an additional approved method of contraception starting at Visit 1 and throughout the entire study period and for 1 month after the last dose of study drug. Pregnant or lactating females are excluded. Subjects must have a history of heartburn, identified as their main complaint, for 6 months or longer.Subjects must have documentation of a minimum of 5 moderate to severe heartburn episodes, 3 of which occur during the daytime and 1 of which occurs during the nighttime, during the last 7 days before randomization. Subjects must be able to read, write, and understand the language of the symptom dairy.

Who cannot join

  • Subjects will be excluded from the study if they are found to have erosive esophagitis during esophagogastroduodenoscopy (EGD) at Screening, 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 acid hypersecretory conditions, or current gastric or duodenal ulcer. Subjects will be excluded if they are found to have current or a history of cancer, with the exception of fully excised skin basal cell carcinoma, inflammatory bowel disease, a history of esophageal, gastric and duodenal surgery, except simple closure of a perforated ulcer. Subjects will be excluded who require daily use of nonsteroidal anti-inflammatory drugs (NSAIDs), oral steroids (>=20 mg/day prednisone or equivalent), or aspirin (>325 mg/day). Female subjects will be excluded who are pregnant, lactating, or have a positive B-human gonadotropin test at Screening/Baseline. Subjects will be excluded who are known to be human immunodeficiency virus (HIV) positive, have participated in another investigational drug study within 30 days prior to screening or are expected to receive an investigational drug during this trial. Subjects who are unwilling to provide informed consent will be excluded.

Trial locations and contacts

98 sites in 1 country.

98 sites in 1 country

United States98 sites

  • Study site

    Altamonte Springs, Florida, 32701

  • Study site

    Anaheim, California, 92801

  • Study site

    Asheville, North Carolina, 28801

  • Study site

    Athens, Alabama, 35611

  • Study site

    Boone, North Carolina, 28607

  • Study site

    Bountiful, Utah, 84010

  • Study site

    Boynton Beach, Florida, 33437

  • Study site

    Bridgeport, Connecticut, 6606

  • Study site

    Butte, Montana, 59701

  • Study site

    Cape Coral, Florida, 33904

  • Study site

    Charleston, South Carolina, 29414

  • Study site

    Charlotte, North Carolina, 28209

  • Study site

    Charlottesville, Virginia, 22911

  • Study site

    Chaska, Minnesota, 55318

  • Study site

    Chesterfield, Michigan, 48047

  • Study site

    Chicago, Illinois, 60622

  • Study site

    Christiansburg, Virginia, 24073

  • Study site

    Cincinnati, Ohio, 45219

  • Study site

    Corsicana, Texas, 75110

  • Study site

    Decatur, Georgia, 30033

  • Study site

    Durham, North Carolina, 277'13

  • Study site

    Encinitas, California, 92024

  • Study site

    Evansville, Indiana, 47714

  • Study site

    Fayetteville, North Carolina, 28304

  • Study site

    Franklin, Tennessee, 37067

  • Study site

    Gallipolis, Ohio, 45631

  • Study site

    Great Neck, New York, 11021

  • Study site

    Great Neck, New York, 11023

  • Study site

    Greesnboro, North Carolina, 27265

  • Study site

    Haddon Heights, New Jersey, 8035

  • Study site

    Hagerstown, Maryland, 21742

  • Study site

    Hialeah, Florida, 33012

  • Study site

    High Point, North Carolina, 27262

  • Study site

    Hollywood, Maryland, 20636

  • Study site

    Houston, Texas, 77030

  • Study site

    Houston, Texas, 77090

  • Study site

    Huntsville, Alabama, 35801

  • Study site

    Irvine, California, 92618

  • Study site

    Jackson, Tennessee, 38301

  • Study site

    Jacksonville, North Carolina, 28546

  • Study site

    Johnson City, Tennessee, 37604

  • Study site

    Joshson City, Tennessee, 37601

  • Study site

    Kinston, North Carolina, 28501

  • Study site

    Lake Charles, Louisiana, 70601

  • Study site

    Lake Success, New York, 11042

  • Study site

    Lancaster, California, 93534

  • Study site

    Laredo, Texas, 78041

  • Study site

    Little Rock, Arkansas, 72205

  • Study site

    Los Angeles, California, 90301

  • Study site

    Madison, Wisconsin, 53715

  • Study site

    Mentor, Ohio, 44060

  • Study site

    Merced, California, 95340

  • Study site

    Metairie, Louisiana, 70006

  • Study site

    Mexico, Missouri, 65265

  • Study site

    Miami, Florida, 33133

  • Study site

    Miami, Florida, 33143

  • Study site

    Miami, Florida, 33144

  • Study site

    Milwaukee, Wisconsin, 53209

  • Study site

    Monroe, Wisconsin, 53566

  • Study site

    Nashville, Tennessee, 37203

  • Study site

    Nashville, Tennessee, 37211

  • Study site

    New Bern, North Carolina, 28562

  • Study site

    New Smyrna Beach, Florida, 32168

  • Study site

    Newnam, Georgia, 30263

  • Study site

    Norman, Oklahoma, 73071

  • Study site

    Ocean City, New Jersey, 7712

  • Study site

    Oceanside, California, 92056

  • Study site

    Odessa, Texas, 79761

  • Study site

    Ogden, Utah, 84405

  • Study site

    Oklahoma City, Oklahoma, 73112

  • Study site

    Orange, California, 92869

  • Study site

    Orlando, Florida, 32806

  • Study site

    Overland Park, Texas, 66215

  • Study site

    Pasadena, California, 91105

  • Study site

    Perrysburg, Ohio, 43551

  • Study site

    Pittsford, New York, 14534

  • Study site

    Raleigh, North Carolina, 27612

  • Study site

    Rochester, New York, 14609

  • Study site

    Rutherford College, North Carolina, 28671

  • Study site

    Sacramento, California, 95823

  • Study site

    San Antonio, Texas, 78229

  • Study site

    San Diego, California, 92103

  • Study site

    San Diego, California, 92117

  • Study site

    San Diego, California, 92123

  • Study site

    Shreveport, Louisiana, 71103

  • Study site

    Simpsonville, South Carolina, 29681

  • Study site

    Sugar Land, Texas, 77479

  • Study site

    Tampa, Florida, 33613

  • Study site

    Troy, Michigan, 48098

  • Study site

    Tucson, Arizona, 85712

  • Study site

    Vineland, New Jersey, 8360

  • Study site

    Voorhees Township, New Jersey, 8043

  • Study site

    Wellington, Florida, 33414

  • Study site

    West Valley City, Utah, 84120

  • Study site

    Wheat Ridge, Colorado, 80033

  • Study site

    Wichita, Kansas, 67203

  • Study site

    Wichita, Kansas, 67207

  • Study site

    Zephyrhills, Florida, 33542

Other trials in United States

About this study

Official title: A Multicenter Randomized Double-Blind Study to Compare the Efficacy, Safety, and Tolerability of Rabeprazole ER 50 mg With Placebo in Subjects With Symptomatic Gastroesophageal Reflux Disease (sGERD)

The purpose of this study is to compare the efficacy, safety and tolerability of rabeprazole extended release (ER) 50 mg with placebo in subjects with symptomatic gastroesophageal reflux disease (sGERD).

Being tested
rabeprazole sodium, Placebo
Keywords
Gastroesophageal Reflux Disease, GERD
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 rabeprazole sodium extended release

    One rabeprazole extended release (ER) 50 mg capsule daily; rescue medication will be provided to subjects to take as needed.

  • PlaceboDrug

    One rabeprazole placebo capsule daily; rescue medication will be provided to subjects to take as needed.

Study groups in NCT00911534
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: rabeprazole sodium
2Placebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. Mean Percentage of Diary-Recorded Heartburn-Free Days at Week 4

    Participants completed a daily symptom diary. A heartburn-free day was defined as participant report of 'No Heartburn' from nighttime and daytime of the diary for the same day.

    Measured: Week 4

Secondary outcomes (1)

  1. Change From Baseline in Average Daily Severity Score of Gastroesophageal Reflux Disease (GERD)-Related Symptoms at Week 4

    Participants collected GERD-associated symptoms of daytime heartburn, nighttime heartburn and regurgitation in daily symptom diary. Daytime episodes were defined as those that occurred after arising in the morning until retiring in the evening, and nighttime episodes were defined as those that occurred during the night while sleeping or trying to sleep. The severity score was calculated was based on a 5-point Likert scale ranging from 0 (no symptom) to 4 (very severe symptom); higher scores indicated greater disease activity.

    Measured: Baseline and 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 posted2 Jun 2009 (estimated)
  2. Study startJan 2009
  3. Primary completionJul 2009
  4. Study completionOct 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
305 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00911534
Sponsor's protocol ID
E3810-A001-307
Status last verified
Nov 2015
First submitted
29 May 2009
Last updated
2 Feb 2016

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing rabeprazole sodium in people with Symptomatic Gastroesophageal Reflux Disease (sGERD), run by Eisai Inc. at 98 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 1 inclusion and 1 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 2 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 98 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. Some participants in this study may receive a placebo. 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 2 Feb 2016). 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?

Mean Percentage of Diary-Recorded Heartburn-Free Days at Week 4 (time frame: Week 4). 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 NCT00911534.

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 2 Feb 2016.

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