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) - Not applicable

• Register: EUCTR
• Last refreshed on: 29 May 2012
• Main ID: EUCTR2007-006046-17-BG
• Date of registration: 15/10/2008
• Prospective Registration: No
• Primary sponsor: Eisai Limited
• Public 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) - Not applicable
• Scientific 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) - Not applicable
• Date of first enrolment: 06/10/2008
• Target sample size: 1060
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-006046-17
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: yes Other: no

Countries of recruitment

Bulgaria, Estonia, France, Germany, Hungary, Latvia, Lithuania

Key inclusion & exclusion criteria

Inclusion criteria:
•Male or female, ages 18 to 75 years.
•History of GERD symptoms (such as acid regurgitation, dyspepsia, chest or epigastric pain) 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 LA grades C or D based on EGD taken within 14 days prior to enrollment
•Subjects who are H. Pylori negative based on Urea Breath Test (UBT)
•Females should be either of nonchildbearing potential (defined as having undergone surgical sterilization, or postmenopausal [age 50 and amenorrheic for 12 months]) or of childbearing potential. For females of childbearing potential, they must have a negative serum ß-human chorionic gonadotropin (ß-hCG) at Visit 1 and negative urine pregnancy test prior to randomization at Visit 3. Female subjects of childbearing potential must agree to use medically acceptable methods of contraception (e.g., abstinence, or a double-barrier method [e.g., condom + spermicide, condom + diaphragm with spermicide], or intrauterine device, or have a vasectomized partner) starting at Visit 1 and throughout the entire study period and for 1 month after the last dose of study drug. Those women using hormonal contraceptives must also be using an additional approved method of contraception (as described previously) starting at Visit 1 and continuing throughout the entire study period and for 1 month after the last dose of study drug. Pregnant and/or lactating females are excluded.
•Subjects must be able to read, write, and understand the language of the symptom diary.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
•Subjects who are known to be HIV-positive
•Subjects who experience drastic weight loss (>10% total weight) during the 2-month period prior to screening
•Use of prescription or non-prescription PPIs or histamine (H2) receptor antagonists within 2 weeks before the screening EGD.
•Use of antimicrobials, PPIs or bismuth preparations within 2 weeks before the UBT for H. pylori screening
•Use of antacids during the study, except for study-supplied antacid
•Current or a history of oesophageal motility disorders (achalasia, scleroderma, or oesophageal spasm)
•Current or a history of Barrett's esophagus current oesophageal strictures. Oesophagitis (known or suspected to be due to aetiology other than GERD such as infection, medications).
•Current or a history of Zollinger-Ellison syndrome and other acid hyper-secretory 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 oesophageal, gastric and duodenal- surgery except simple suturing of an ulcer
•Subjects with clinically relevant abnormal laboratory tests at the screening visit, including liver enzymes greater than 2 times the upper limit of normal
•Evidence of significant hepatic, renal, respiratory, endocrine, haematologic, neurologic, psychiatric, or cardiovascular system abnormalities, unless the sponsor and investigator agreed that the nature and severity of any abnormality is unlikely to interfere with the conduct of the study, the interpretation of study results, or the health of the subject during the study
•Females who are pregnant or lactating
•Any condition that would make the subject, in the opinion of the investigator or sponsor, unsuitable for the study
•Subjects who have participated in another investigational drug study within 30 days prior to screening or were expected to receive an investigational drug during this trial
•Subjects with a history of allergy or sensitivity to any component of Aciphex®, Nexium®, or antacid
•Active alcohol and substance abuse
•Subjects who were unable or unwilling to give informed consent.
•Subjects who were unable or unwilling to complete a daily diary.
•Subjects who were unable or unwilling to return for all required study visits.
•Subjects who are unable or unwilling to abide by requirements of the study or violate the restrictions of the study as related to prohibited medications (defined in Section 10.6.3)
•Subjects with difficulty in swallowing the study medication
•Subjects who require daily use of non-steroidal anti-inflammatory drugs (NSAIDs), oral steroids (=20 mg/day prednisone or equivalent), or aspirin (>325 mg/day).




Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Erosive gastro-oesophageal reflux disease
MedDRA version: 9.1 Level: PT Classification code 10017885 Term: Gastrooesophageal reflux disease

Intervention(s)

Product Name: Nexium Capsule 40mg
Pharmaceutical Form: Capsule*
INN or Proposed INN: Nexium
CAS Number: 95382-33-5
Other descriptive name: esomeprazole magnesium
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40mg-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use

Product Name: Rabeprazole extended release
Product Code: E3810
Pharmaceutical Form: Capsule*
INN or Proposed INN: Rabeprazole
CAS Number: 117976-89-3
Current Sponsor code: E3810
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use

Primary Outcome(s)

Secondary Objective: To evaluate safety of RAB ER 50 mg associated with 4 to 8 weeks of treatment among subjects with eGERD, endoscopically confirmed to be Los Angeles (LA) grades C and D at baseline.

Primary end point(s): Primary efficacy endpoint #1: the percentage of subjects who achieve endoscopically confirmed healing by 4 weeks after initiation of treatment with RAB ER 50 mg versus ESO 40 mg among subjects with eGERD and with LA grades C and D at baseline.

Superiority will be claimed if the 2-sided p-value is less than 0.05.

If the criteria for superiority are met at week 4, primary endpoint #2 will subsequently be tested.

Primary efficacy endpoint #2: the percentage of subjects who achieve endoscopically confirmed healing by 8 weeks after initiation of treatment with RAB ER 50 mg versus ESO 40 mg among subjects with eGERD and with LA grades C and D at baseline.

Main Objective: To compare efficacy (i.e. healing and symptom relief) of Rabeprazole (RAB) Extended-Release (ER) 50 mg versus Esomeprazole (ESO) 40 mg after 4-8 weeks of treatment among subjects with erosive GERD (eGERD), endoscopically confirmed to be Los Angeles (LA) grades C and D at baseline.

Secondary ID(s)

E3810-G000-302

2007-006046-17-LV