- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef 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
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 3
Contacten en locaties
Studie Locaties
-
-
Aichi-Prefecture
-
Aichi-Gun, Aichi-Prefecture, Japan, 480-1103
-
Nagoya, Aichi-Prefecture, Japan, 467-0001
-
Nagoya, Aichi-Prefecture, Japan, 466-0065
-
-
Fukuoka-Prefecture
-
Chikushino, Fukuoka-Prefecture, Japan, 818-0024
-
Chikushino, Fukuoka-Prefecture, Japan, 818-0067
-
Fukuoka, Fukuoka-Prefecture, Japan, 813-0003
-
Kita-kyushu, Fukuoka-Prefecture, Japan, 807-1262
-
-
Gunma-Prefecture
-
Maebashi, Gunma-Prefecture, Japan, 371-0034
-
-
Hiroshima-Prefecture
-
Hiroshima, Hiroshima-Prefecture, Japan, 734-0037
-
Hiroshima, Hiroshima-Prefecture, Japan, 730-0052
-
-
Hokkaido-Prefecture
-
Sapporo, Hokkaido-Prefecture, Japan, 003-0021
-
Sapporo, Hokkaido-Prefecture, Japan, 060-0061
-
Sapporo, Hokkaido-Prefecture, Japan, 060-0814
-
-
Kochi-Prefecture
-
Kochi, Kochi-Prefecture, Japan, 780-0901
-
-
Kyoto-Prefecture
-
Kyoto, Kyoto-Prefecture, Japan, 602-0000
-
Kyoto, Kyoto-Prefecture, Japan, 606-8397
-
-
Miyagi-Prefecture
-
Sandai, Miyagi-Prefecture, Japan, 980-0872
-
Sendai, Miyagi-Prefecture, Japan, 984-0075
-
-
Osaka-Prefecture
-
Moriguchi, Osaka-Prefecture, Japan, 570-0021
-
Osaka, Osaka-Prefecture, Japan, 530-0012
-
Osaka, Osaka-Prefecture, Japan, 545-0051
-
Osaka, Osaka-Prefecture, Japan, 536-0002
-
-
Saga-Prefecture
-
Saga, Saga-Prefecture, Japan, 849-0937
-
-
Saitama-Prefecture
-
Kawaguchi, Saitama-Prefecture, Japan, 332-0021
-
-
Shimane-Prefecture
-
Izumo, Shimane-Prefecture, Japan, 693-0021
-
Matsue, Shimane-Prefecture, Japan, 690-0886
-
-
Shizuoka-Prefecture
-
Hamamatsu, Shizuoka-Prefecture, Japan, 431-3125
-
-
Tokyo
-
Shinagawa-ku, Tokyo, Japan, 140-0011
-
Shinjuku-ku, Tokyo, Japan, 162-0052
-
-
Yamaguchi-Prefecture
-
Sanyoonoda, Yamaguchi-Prefecture, Japan, 756-0076
-
Sanyoonoda, Yamaguchi-Prefecture, Japan, 757-0002
-
Ube, Yamaguchi-Prefecture, Japan, 755-0046
-
Ube, Yamaguchi-Prefecture, Japan, 755-0004
-
Ube, Yamaguchi-Prefecture, Japan, 755-0067
-
Ube, Yamaguchi-Prefecture, Japan, 755-0077
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: 1
|
E3810 5mg: once daily orally for 4 weeks
E3810 10mg: once daily orally for 4 weeks
|
Experimenteel: 2
|
E3810 5mg: once daily orally for 4 weeks
E3810 10mg: once daily orally for 4 weeks
|
Placebo-vergelijker: 3
|
Placebo: once daily orally for 4 weeks
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Percentage of Participants With Complete Relief of Heartburn at Final Evaluation
Tijdsspanne: 4 weeks
|
"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
|
4 weeks
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie directeur: Nobuyuki Sugisaki, Eisai Co., Ltd - Development Clinical Research Department. Clinical Research Center
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het spijsverteringsstelsel
- Gastro-intestinale aandoeningen
- Maag Ziekten
- Gastro-enteritis
- Darmziekten
- Slokdarmmotiliteitsstoornissen
- Verslikkingsstoornissen
- Slokdarmaandoeningen
- Slokdarmontsteking
- Maagzweer
- Ziekten van de twaalfvingerige darm
- Gastro-oesofageale reflux
- Slokdarmontsteking, peptisch
- Moleculaire mechanismen van farmacologische werking
- Enzymremmers
- Gastro-intestinale middelen
- Middelen tegen zweren
- Protonpompremmers
- Rabeprazol
Andere studie-ID-nummers
- E3810-J081-461
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Niet-erosieve gastro-oesofageale refluxziekte
-
Dartmouth-Hitchcock Medical CenterIngetrokkenGastro-oesofageale refluxziekte PPI-non-responders
Klinische onderzoeken op E3810
-
Teresa Helsten, MDClovis Oncology, Inc.IngetrokkenGeavanceerde kankerVerenigde Staten
-
Eisai Co., Ltd.Voltooid
-
Eisai Co., Ltd.Voltooid
-
Eisai Co., Ltd.Voltooid
-
Eisai Co., Ltd.VoltooidMaag- of duodenumzweren veroorzaakt door een lage dosis aspirineJapan
-
Eisai Co., Ltd.VoltooidMaagzweren Zweren in de twaalfvingerige darm veroorzaakt door een lage dosis aspirineJapan
-
University of California, San FranciscoInsmed IncorporatedBeëindigd
-
Haihe Biopharma Co., Ltd.OnbekendKleincellige longkanker in een uitgebreid stadiumChina