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Early Gastric AdenocarcinomaPhase 4NCT00844675

Effects of Oral Rabeprazole on the Prevention of Ulcer Bleeding Following Endoscopic Mucosal Resection

A Phase 4 study testing rabeprazole in people with Early Gastric Adenocarcinoma and Adenocarcinoma, Tubular, run by The Catholic University of Korea at 1 site in South Korea.

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

The purpose of this study is: To examine if oral administration of Pariet (proton pump inhibitor, 20mg tablets, twice daily for 5 days) before Endoscopic mucosal resection(EMR) exhibits preventive effects of ulcer bleeding compared with placebo group (preoperative administration of placebo) To evaluate the effects on… Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
rabeprazole
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteSouth Korea
Study dates
Oct 2007to Mar 2012
Phase
Phase 4
Are there results?
None posted in the registry

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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients who have EMR planned as well as meet the criteria described below will be selected as study subjects
  • Patients in whom EMR is indicated:
  • Gastric adenoma
  • Early gastric adenocarcinoma
  • Moderately or well differentiated adenocarcinoma
  • Gastric cancer limited to only mucosa on endoscopic ultrasonography
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  • No invasion of lymph nodes or metastases (diagnosed by CT)
  • EMR to be performed for other diagnostic purposes
  • Women of child-bearing potential should avoid pregnancy
  • Subjects who consented to a EMR procedure in writing

Who cannot join

  • Patients who meet the criteria described below should be excluded from study subjects:
  • Younger than 18 years old
  • Patients with a history of upper gastrointestinal surgery or vagotomy
  • Patients with serious adverse reactions secondary to cardiac, renal, hepatic, or hematologic diseases (e.g. creatinine> 2.5 mg/dl, total bilirubin >3.0 mg/dl)
  • Patients with diseases that may have a great impact on the clinical study
  • Patients to whom the stimulation of gastrointestinal movement poses risks as in gastrointestinal bleeding, mechanical ileus and perforation
Show all 17Show fewer
  • Women who are pregnant or nursing
  • Patients who are being treated with adrenocorticoid steroids, nonsteroidal anti-inflammatory drugs including aspirin, or other ulcer inducers
  • Patients who are taking other antiulcer drugs (antacids, antihistamines, etc) that may affect the efficacy assessments of the study drug (but, except for patients not taking the drugs over 7 days)
  • Patients with severe psychiatric diseases
  • Patients who received other investigational drugs within 30 days prior to the start of this study or who are currently participating in other clinical study
  • Patients who did not consent to the clinical study
  • Patients who can not be examined
  • Patients with bleeding tendency
  • Patients with esophageal varices
  • Patients with esophageal ulcer, stricture, or obstruction
  • Patients who have pacemaker or implantable cardiac defibrillator in place

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Catholic University, Gangnam St. Mary's Hospital

    Seoul, Ban-po Dong 505, 137-040

Other trials in South Korea

About this study

Official title: Effects of Preoperative Administration of Oral Rabeprazole on the Prevention of Ulcer Bleeding Following Endoscopic Mucosal Resection(EMR): Prospective, Randomized, Placebo-controlled, Comparative Study

The purpose of this study is:

  • To examine if oral administration of Pariet (proton pump inhibitor, 20mg tablets, twice daily for 5 days) before Endoscopic mucosal resection(EMR) exhibits preventive effects of ulcer bleeding compared with placebo group (preoperative administration of placebo)
  • To evaluate the effects on the suppression of acid secretion of preoperative administration of an Proton pump inhibitor
Read the detailed description
  • Endoscopic mucosal resection (EMR) is less invasive than surgery and is known to be general treatment for early gastric cancer or gastric adenoma when patients' quality of life is taken into consideration. However, major complications such as bleeding and perforation remain to be problematic.1-5 The incidence of these complications is expected to rise as the size of lesions for which EMR is indicated has enlarged. Histamine 2 receptor antagonists (H2RA) and proton pump inhibitors (PPI) have been used for the bleeding,1-3 but the bleeding rate following EMR has been reported to be still high as 1.4% to 24%.1,4 Green et al and Berstad et al cited in their research that intragastric PH should be sustained above 5.4 to prevent bleeding, and PPIs should be administered instead of H2RAs to keep PH above 5.4. Being studied are administration modalities to enhance the therapeutic efficacy of PPIs or H2RAs.1-3 Several studies have already demonstrated that high-dose PPI therapy, for which a PPI was administered twice daily, effectively blocks acid secretion by increasing intragastric pH to neutral.3 Our study team also suggested in a previous study that high-dose PPI therapy was adequate to maintain intragastric pH above 6.
  • PPIs are known to induce the suppression of acid secretion because they destroy a proton pump, yet it takes 5 days to achieve their maximum effects.7,8 It's been suggested that the onset of PPIs is slow to prevent bleeding with administration of a PPI after EMR.4 Therefore, our investigators expect that 5-day administration of an oral PPI before EMR would increase intragastric pH to above 6 and would be at least equal to or superior to intravenous PPIs currently being used in terms of the suppression of acid secretion.
  • This is a prospective, randomized, comparative study to substantiate that oral administration of rabeprazole (Pariet tablets) 20mg twice daily before and after EMR (PO RBP group) will show similar effects on the prevention of bleeding compared with the conventional treatment with iv administration of pantoprazole after EMR but no special medication given before EMR (Placebo group). In addition, we are going to measure intragastric pH among part of study subjects and then to evaluate if the effect of acid suppression in the PO RBP group is superior to that in the placebo group.
Being tested
rabeprazole, placebo
Keywords
endoscopic mucosal resection, Proton Pump Inhibitor, gastrointestinal hemorrhage, rabeprazole
Medical subject headings
Adenocarcinoma, Gastrointestinal Hemorrhage

What participants receive

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

  • rabeprazoleDrug

    Also called Pariet(rabeprazole)

    The rabeprazole group will receive oral rabeprazole 20mg twice day (morning and evening) 30 minutes before meals from 5 days before EMR (D-5) to 1 day before EMR (D-1).

  • placeboDrug

    The placebo group will receive a placebo by mouth twice a day (morning and evening) 30 minutes before meals from 5 days before EMR (D-5) to 1 day before EMR (D-1).

Study groups in NCT00844675
Study groupRoleWhat they receive
rabeprazoleExperimentalrabeprazole
Receives: Drug: rabeprazole
placeboExperimentalplacebo
Receives: Drug: placebo

What is being measured

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

  1. Frequency of bleeding after EMR is performed

    Measured: 4weeks

Secondary outcomes (3)

  1. Number (No./cm2) of visible vessels on the fundus of ulcer on endoscopy performed within 24 hours after EMR

    Measured: day 1

  2. Percentage of a pH change with intragastric pH greater than 6 in 24 hours after EMR

    Measured: day 0

  3. Measurement of a change in the size of ulcer

    Measured: 4weeks

Timeline

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

  1. First posted16 Feb 2009 (estimated)
  2. Study startOct 2007
  3. Primary completionDec 2011
  4. Study completionMar 2012

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 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00844675
Sponsor's protocol ID
RAB-KOR-9035
Status last verified
Oct 2012
First submitted
13 Feb 2009
Last updated
18 Oct 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing rabeprazole in people with Early Gastric Adenocarcinoma and Adenocarcinoma, Tubular, run by The Catholic University of Korea at 1 site in South Korea.

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 10 inclusion and 17 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 18 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Frequency of bleeding after EMR is performed (time frame: 4weeks). 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 NCT00844675.

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 18 Oct 2012.

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