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NCT00165841 · ClinicalTrials.gov registry record · Phase 2

Maintenance Intermittent Therapy for Symptomatic GERD Patients

A Phase 2 study of Gastroesophageal Reflux Disease, sponsored by Eisai.

Completed
Registry status
Phase 2
Development phase
200
Enrollment target
1
Study location

NCT00165841: Completed Phase 2 study of Gastroesophageal Reflux Disease, sponsored by Eisai.

NCT00165841 is a Phase 2 study of Gastroesophageal Reflux Disease that has completed, run by Eisai. The registered enrollment target is 200 participants, below the 348-participant average among 25 other Gastroesophageal Reflux Disease trials with a reported enrollment target (43% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00165841, a Phase 2 study of Gastroesophageal Reflux Disease, has completed, sponsored by Eisai.

COMPLETED
Registry status
Phase 2
Development phase
200 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study to determine the efficacy of 20 mg of rabeprazole given as a maintenance intermittent therapy following acute treatment for Symptomatic Gastroesophageal Reflux Disease (s-GERD).

Primary Outcome

The percentage of heartburn-free days during the 6-month Maintenance Treatment Phase in patients treated with rabeprazole 20 mg compared to patients who received placebo in the ITT Population. Heartburn-free day was defined as no heartburn in both the daytime and nighttime period on a given day. Note a total 388 subjects were enrolled at the beginning of Acute Phase and 200 subjects were enrolled into the double-blind 6-month maintenance treatment phase.

Interventions

  • DRUG Rabeprazole 20 mg

Study Locations (1)

California

  • Quality Care Medical Center Inc. - Vista

Trial Details

FieldValue
Enrollment Target 200 participants
Start Date 2004-10
Est. Completion 2008-06
Phase Phase 2
Eisai

287 total trials

What the finished NCT00165841 record still lists

NCT00165841 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 348-participant average among 25 other Gastroesophageal Reflux Disease trials with a reported enrollment target (43% lower).

The record links to 1 condition, with Gastroesophageal Reflux Disease appearing as the primary indexed condition, and to 1 intervention - of which Rabeprazole 20 mg is the first listed.

NCT00165841 reports a single indexed study location in California.

Frequently Asked Questions

What is clinical trial NCT00165841 about?

NCT00165841 is a clinical study titled "Maintenance Intermittent Therapy for Symptomatic GERD Patients". The purpose of this study to determine the efficacy of 20 mg of rabeprazole given as a maintenance intermittent therapy following acute treatment for Symptomatic Gastroesophageal Reflux Disease (s-GERD).

What is the current status of trial NCT00165841?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 200 participants. The study started on 2004-10. Estimated completion is 2008-06.

What conditions does trial NCT00165841 study?

This clinical trial studies the following conditions: Gastroesophageal Reflux Disease.

What interventions are being tested in trial NCT00165841?

The interventions under investigation include: Rabeprazole 20 mg (DRUG).

Who is sponsoring clinical trial NCT00165841?

This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00165841 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Gastroesophageal Reflux Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00165841's enrollment target sits among peer trials

200 7th of 25 higher than 18 of 25 other Gastroesophageal Reflux Disease trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Gastroesophageal Reflux Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00165841, the US trial registry maintained by the National Library of Medicine. NCT00165841 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.