- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00165646
A Comparative Study on the Efficacy and Safety of E3810 in Patients With Non-erosive Gastroesophageal Reflux Disease
A Double-Blind, Placebo-Controlled, Comparative Study on the Efficacy and Safety of E3810 in Patients With Non-erosive Gastroesophageal Reflux Disease
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 3
Kontakte und Standorte
Studienorte
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Aichi-Prefecture
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Aichi-Gun, Aichi-Prefecture, Japan, 480-1103
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Nagoya, Aichi-Prefecture, Japan, 467-0001
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Nagoya, Aichi-Prefecture, Japan, 466-0065
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Fukuoka-Prefecture
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Chikushino, Fukuoka-Prefecture, Japan, 818-0024
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Chikushino, Fukuoka-Prefecture, Japan, 818-0067
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Fukuoka, Fukuoka-Prefecture, Japan, 813-0003
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Kita-kyushu, Fukuoka-Prefecture, Japan, 807-1262
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Gunma-Prefecture
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Maebashi, Gunma-Prefecture, Japan, 371-0034
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Hiroshima-Prefecture
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Hiroshima, Hiroshima-Prefecture, Japan, 734-0037
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Hiroshima, Hiroshima-Prefecture, Japan, 730-0052
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Hokkaido-Prefecture
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Sapporo, Hokkaido-Prefecture, Japan, 003-0021
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Sapporo, Hokkaido-Prefecture, Japan, 060-0061
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Sapporo, Hokkaido-Prefecture, Japan, 060-0814
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Kochi-Prefecture
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Kochi, Kochi-Prefecture, Japan, 780-0901
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Kyoto-Prefecture
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Kyoto, Kyoto-Prefecture, Japan, 602-0000
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Kyoto, Kyoto-Prefecture, Japan, 606-8397
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Miyagi-Prefecture
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Sandai, Miyagi-Prefecture, Japan, 980-0872
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Sendai, Miyagi-Prefecture, Japan, 984-0075
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Osaka-Prefecture
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Moriguchi, Osaka-Prefecture, Japan, 570-0021
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Osaka, Osaka-Prefecture, Japan, 530-0012
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Osaka, Osaka-Prefecture, Japan, 545-0051
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Osaka, Osaka-Prefecture, Japan, 536-0002
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Saga-Prefecture
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Saga, Saga-Prefecture, Japan, 849-0937
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Saitama-Prefecture
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Kawaguchi, Saitama-Prefecture, Japan, 332-0021
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Shimane-Prefecture
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Izumo, Shimane-Prefecture, Japan, 693-0021
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Matsue, Shimane-Prefecture, Japan, 690-0886
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Shizuoka-Prefecture
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Hamamatsu, Shizuoka-Prefecture, Japan, 431-3125
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Tokyo
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Shinagawa-ku, Tokyo, Japan, 140-0011
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Shinjuku-ku, Tokyo, Japan, 162-0052
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Yamaguchi-Prefecture
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Sanyoonoda, Yamaguchi-Prefecture, Japan, 756-0076
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Sanyoonoda, Yamaguchi-Prefecture, Japan, 757-0002
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Ube, Yamaguchi-Prefecture, Japan, 755-0046
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Ube, Yamaguchi-Prefecture, Japan, 755-0004
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Ube, Yamaguchi-Prefecture, Japan, 755-0067
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Ube, Yamaguchi-Prefecture, Japan, 755-0077
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
The patients to be included will be outpatients who meet all of the following criteria. No specific gender is asked.
<For the observation period>
- Patients who have "heartburn" 2 days a week or more for consecutive weeks during 3 weeks prior to pre-observation screening. If a day of screening and a day of starting observation (date of registration) are different, heartburn must continuously be present during the in-between period.
- Patients who meet both 1) and 2) below; 1) The symptom is a burning sensation arising from the stomach or the lower chest.
2) The symptom tends to appear frequently or is aggravated after eating, when bending a body forward, and/or when pressing on the abdomen.
(3) Patients categorized in "grade M" (discoloring type: minimal change) according to the Los Angeles System (2nd Modification) for Classification of Reflux Esophagitis.
(4) Patients who are 20 years old or older at the time of obtaining consent. (5) Patients who are informed of the objective and details of the study and give written consent for study entry.
<For the treatment period>
- Patients who have "heartburn" on 2 days a week or more in 7 days immediately before the treatment period (during the observation period).
- Patients with "heartburn diary" that is completely filled out for 7 days until the treatment period (during the observation period). If the observation period is 8 days or longer, those with heartburn diary of which entries are fulfilled 80% or more during the observation period.
- Patients with 80% or better drug compliance for antacids during the observation period.
Exclusion Criteria:
Patients who meet any of the following criteria will be excluded from the study.
- Patients who cannot keep adequate entries of heartburn diary by themselves.
- Patients who strongly complain "feeling of heavy stomach" and/or "abdominal bloating."
- Patients who have a complication or history of psychiatric or psychosomatic disease (e.g., manic-depressive psychosis, obsessive-compulsive neurosis, or others) or those who are on an antidepressant or anti-anxiety agent (accepted if only for a hypnotic treatment).
- Patients who have undergone Helicobacter pylori eradication therapy, and less than 6 months have elapsed from the end of H. pylori eradication therapy to the beginning of the observation period. : The same day 6 months earlier, and the day at the end of 6 months earlier if it is at the end of month.
- Patients with open gastric or duodenal ulcer.
- Patients with acute gastritis.
- Patients with a history of any surgical intervention that affect peptic secretion (e.g., upper gastrointestinal tract resection and/or vagotomy).
- Patients with Barrett's esophagus, esophageal stenosis, or pyloric stenosis.
- Patients with scleroderma.
- Patients with a history or complication of angina pectoris.
- Patients who work at night (working for a night-shift).
- Patients who received proton pump inhibitors (PPIs) within 3 weeks prior to pre-observation screening
- Patients who need NSAIDs (except topical preparations), steroids (except topical preparations), and/or aspirin treatment every day
- Patients receiving dialysis therapy
- Patients with a serious complication such as cardiovascular disease (e.g., myocardial infarction), hematological disorder (e.g., aplastic anemia), renal disease (e.g., acute or chronic renal failure), hepatic disease (e.g., cirrhosis), or malignant tumor.
- Patients with known hypersensitivity to antacids or PPIs.
- Patients who are pregnant or those with childbearing potential, or those who wish to become pregnant or are lactating during the study period.
- Patients receiving another investigational drug or those who received another investigational drug within 6 months prior to pre-observation screening : Registration is allowed on the same day of 6 months earlier, and the day at the end of 6 months earlier if it is at the end of month.
- Patients who are judged to be ineligible for the study entry by the investigator or subinvestigator.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: 1
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E3810 5mg: once daily orally for 4 weeks
E3810 10mg: once daily orally for 4 weeks
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Experimental: 2
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E3810 5mg: once daily orally for 4 weeks
E3810 10mg: once daily orally for 4 weeks
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Placebo-Komparator: 3
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Placebo: once daily orally for 4 weeks
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Percentage of Participants With Complete Relief of Heartburn at Final Evaluation
Zeitfenster: 4 weeks
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"Heartburn diary" will be given to each subject and ask him/her to keep the diary every day throughout the study period.
The subject will be requested to record the occurrence of heartburn during the daytime and the nighttime in the diary.
Primary End Point is the rate of complete disappearance of heartburn.
The rate of heartburn do not occur in the past week will be calculated based on the diary.
Participants were evaluated at week 4 about episodes of heartburn in the last 7 days
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4 weeks
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: Nobuyuki Sugisaki, Eisai Co., Ltd - Development Clinical Research Department. Clinical Research Center
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Verdauungssystems
- Magen-Darm-Erkrankungen
- Magenerkrankungen
- Gastroenteritis
- Darmerkrankungen
- Motilitätsstörungen des Ösophagus
- Schluckstörungen
- Erkrankungen der Speiseröhre
- Ösophagitis
- Magengeschwür
- Zwölffingerdarmerkrankungen
- Gastroösophagealer Reflux
- Ösophagitis, Magenschleimhautentzündung
- Molekulare Mechanismen der pharmakologischen Wirkung
- Enzym-Inhibitoren
- Magen-Darm-Mittel
- Mittel gegen Geschwüre
- Protonenpumpenhemmer
- Rabeprazol
Andere Studien-ID-Nummern
- E3810-J081-461
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Nicht-erosive gastroösophageale Refluxkrankheit
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Dartmouth-Hitchcock Medical CenterZurückgezogenGastroösophageale Refluxkrankheit PPI Non-Responder
Klinische Studien zur E3810
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Teresa Helsten, MDClovis Oncology, Inc.ZurückgezogenFortgeschrittener KrebsVereinigte Staaten
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Eisai Co., Ltd.Abgeschlossen
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Eisai Co., Ltd.Abgeschlossen
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Eisai Co., Ltd.Abgeschlossen
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Eisai Co., Ltd.Abgeschlossen
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Eisai Inc.Abgeschlossen
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Eisai Co., Ltd.AbgeschlossenMagen- oder Zwölffingerdarmgeschwüre, die durch niedrig dosiertes Aspirin verursacht werdenJapan
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Eisai Co., Ltd.AbgeschlossenMagengeschwüre Zwölffingerdarmgeschwüre, die durch niedrig dosiertes Aspirin verursacht werdenJapan
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University of California, San FranciscoInsmed IncorporatedBeendet
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Haihe Biopharma Co., Ltd.UnbekanntKleinzelliger Lungenkrebs im ausgedehnten StadiumChina