Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the efficacy and safety of rabeprazole compared to placebo in Japanese subjects with Functional Dyspepsia.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rabeprazole 10 mg | Experimental |
| |
| Rabeprazole 20 mg | Experimental |
| |
| Rabeprazole 40 mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rabeprazole | Drug | Rabeprazole 10 mg tablet taken orally once daily after breakfast for 8 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Complete Dyspepsia Symptom Relief | The rate of complete dyspepsia symptom relief according to the Dyspepsia Symptom Questionnaire (DSQ) was defined as a score of 1 for all four major dyspeptic symptoms at week 8 and according to the diary defined as all four dyspepsia symptoms recorded absent during the 7 days prior to week 8. Values presented as percentage of participants. | Up to 8 Weeks (including 7 days prior) |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Satisfactory Symptom Relief | The rate of satisfactory symptom relief according to the DSQ defined as scores of <= 2 for all four major dyspepsia symptoms at week 8 and the diary recordings defined as a frequency of <= 1 day for all four major dyspepsia symptoms during the 7 days before week 8. Lastly, treatment success according to the participants' impression questionnaire where participants answered "yes" or "no" when asked if given the choice, whether they would want to continue to take the study drug after clinical trial completion. Values presented as percentage of participants. |
Not provided
Inclusion criteria:
-Participants diagnosed as Functional Dyspepsia according to Rome III criteria.
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yoshiumi Okubo | Eisai Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagoya | Aichi-ken | Japan | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23957383 | Derived | Iwakiri R, Tominaga K, Furuta K, Inamori M, Furuta T, Masuyama H, Kanke K, Nagahara A, Haruma K, Kinoshita Y, Higuchi K, Takahashi S, Kusano M, Iwakiri K, Kato M, Hongo M, Hiraishi H, Watanabe S, Miwa H, Naito Y, Fujimoto K, Arakawa T. Randomised clinical trial: rabeprazole improves symptoms in patients with functional dyspepsia in Japan. Aliment Pharmacol Ther. 2013 Oct;38(7):729-40. doi: 10.1111/apt.12444. Epub 2013 Aug 20. |
Not provided
Not provided
Participants were initially enrolled into a 1- or 2-week run-in period (single-blinded administration of placebo). Participants who did not respond to placebo were randomized to an 8-week treatment period (double-blinded administration) of rabeprazole 10 mg, 20 mg, 40 mg, or placebo, once daily after breakfast.
This study was recruited at 66 centers in Japan during the period of 21-April-2010 to 12-Aug-2011.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Rabeprazole 10 mg | Rabeprazole 10 mg tablet taken orally once daily after breakfast for 8 weeks. |
| FG001 | Rabeprazole 20 mg | Rabeprazole 20 mg tablet taken orally once daily after breakfast for 8 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Rabeprazole | Drug | Rabeprazole 20 mg tablet taken orally once daily after breakfast for 8 weeks. |
|
|
| Rabeprazole | Drug | Rabeprazole 40 mg tablet taken orally once daily after breakfast for 8 weeks. |
|
|
| Placebo | Drug | Rabeprazole Placebo tablet taken orally once daily after breakfast for 8 weeks. |
|
|
| Up to 8 Weeks (including 7 days prior) |
| Akita |
| Akita |
| Japan |
| Chikushino-shi | Fukuoka | Japan |
| Fukuoka | Fukuoka | Japan |
| Kitakyushu | Fukuoka | Japan |
| Gifu | Gifu | Japan |
| Maebashi | Gunma | Japan |
| Hiroshima | Hiroshima | Japan |
| Sapporo | Hokkaido | Japan |
| Kobe | Hyōgo | Japan |
| Nishinomiya | Hyōgo | Japan |
| Tsuchiura | Ibaraki | Japan |
| Takamatsu | Kagawa-ken | Japan |
| Kagoshima | Kagoshima-ken | Japan |
| Yokohama | Kanagawa | Japan |
| Kochi | Kochi | Japan |
| Kumamoto | Kumamoto | Japan |
| Kyoto | Kyoto | Japan |
| Sendai | Miyagi | Japan |
| Miyazaki | Miyazaki | Japan |
| Ōita | Oita Prefecture | Japan |
| Yufu | Oita Prefecture | Japan |
| Nakagami | Okinawa | Japan |
| Hirakata | Osaka | Japan |
| Moriguchi | Osaka | Japan |
| Osaka | Osaka | Japan |
| Suita | Osaka | Japan |
| Takatsuki | Osaka | Japan |
| Karatsu | Saga-ken | Japan |
| Saga | Saga-ken | Japan |
| Saitama | Saitama | Japan |
| Kusatsu | Shiga | Japan |
| Izumo | Shimane | Japan |
| Fujieda | Shizuoka | Japan |
| Hamamatsu | Shizuoka | Japan |
| Shizuoka | Shizuoka | Japan |
| Ōtawara | Tochigi | Japan |
| Shimotsuga | Tochigi | Japan |
| Bunkyo | Tokyo | Japan |
| Mitaka | Tokyo | Japan |
| Nakano City | Tokyo | Japan |
| Ōta-ku | Tokyo | Japan |
| Setagaya City | Tokyo | Japan |
| Shibuya City | Tokyo | Japan |
| Shinagawa | Tokyo | Japan |
| Yamagata | Yamagata | Japan |
| FG002 | Rabeprazole 40 mg | Rabeprazole 40 mg tablet taken orally once daily after breakfast for 8 weeks. |
| FG003 | Placebo | Rabeprazole Placebo tablet taken orally once daily after breakfast for 8 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Per Protocol Set (PPS): was defined as those participants who complied with the study protocol. N= 338 participants were enrolled at study start. However, a total of 307 participants were included in PPS for efficacy evaluation.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Rabeprazole 10 mg | Rabeprazole 10 mg tablet taken orally once daily after breakfast for 8 weeks. |
| BG001 | Rabeprazole 20 mg | Rabeprazole 20 mg tablet taken orally once daily after breakfast for 8 weeks. |
| BG002 | Rabeprazole 40 mg | Rabeprazole 40 mg tablet taken orally once daily after breakfast for 8 weeks. |
| BG003 | Placebo | Rabeprazole Placebo tablet taken orally once daily after breakfast for 8 weeks. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rate of Complete Dyspepsia Symptom Relief | The rate of complete dyspepsia symptom relief according to the Dyspepsia Symptom Questionnaire (DSQ) was defined as a score of 1 for all four major dyspeptic symptoms at week 8 and according to the diary defined as all four dyspepsia symptoms recorded absent during the 7 days prior to week 8. Values presented as percentage of participants. | Per Protocol Set (PPS) population defined as those participants who complied with the study protocol. | Posted | Number | Percentage of Participants | Up to 8 Weeks (including 7 days prior) |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Rate of Satisfactory Symptom Relief | The rate of satisfactory symptom relief according to the DSQ defined as scores of <= 2 for all four major dyspepsia symptoms at week 8 and the diary recordings defined as a frequency of <= 1 day for all four major dyspepsia symptoms during the 7 days before week 8. Lastly, treatment success according to the participants' impression questionnaire where participants answered "yes" or "no" when asked if given the choice, whether they would want to continue to take the study drug after clinical trial completion. Values presented as percentage of participants. | Per Protocol Set (PPS) Population: defined as those participants who complied with the study protocol. | Posted | Number | Percentage of participants | Up to 8 Weeks (including 7 days prior) |
|
Up to 8 weeks
Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rabeprazole 10 mg | Rabeprazole 10 mg tablet taken orally once daily after breakfast for 8 weeks. | 0 | 85 | 28 | 85 | ||
| EG001 | Rabeprazole 20 mg | Rabeprazole 20 mg tablet taken orally once daily after breakfast for 8 weeks. | 1 | 85 | 20 | 85 | ||
| EG002 | Rabeprazole 40 mg | Rabeprazole 40 mg tablet taken orally once daily after breakfast for 8 weeks. | 1 | 83 | 31 | 83 | ||
| EG003 | Placebo | Rabeprazole Placebo tablet taken orally once daily after breakfast for 8 weeks. | 1 | 85 | 22 | 85 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Distension | Gastrointestinal disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders |
| |||
| Enterocolitis | Gastrointestinal disorders |
| |||
| Periodontitis | Gastrointestinal disorders |
| |||
| Stomatitis | Gastrointestinal disorders |
| |||
| Gastroenteritis | Infections and infestations |
| |||
| Gastroenteritis Viral | Infections and infestations |
| |||
| Nasopharyngitis | Infections and infestations |
| |||
| Pharyngitis | Infections and infestations |
| |||
| Aspartate Aminotransferase Increased | Investigations |
| |||
| Blood Triglycerides Increased | Investigations |
| |||
| Back Pain | Musculoskeletal and connective tissue disorders |
| |||
| Headache | Nervous system disorders |
| |||
| Upper Respiratory Tract Inflammation | Respiratory, thoracic and mediastinal disorders |
| |||
| Eczema | Skin and subcutaneous tissue disorders |
| |||
| Urticaria | Skin and subcutaneous tissue disorders |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yoshiumi Okubo, Study Director | Eisai Inc. | +81-3-3817-3908 | y4-okubo@hhc.eisai.co.jp |
| ID | Term |
|---|---|
| D004415 | Dyspepsia |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D064750 | Rabeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
| Male |
|
| Diary Recordings (n= 77, n= 76, n=74, n=80) |
|
| OG003 |
| Placebo |
Rabeprazole Placebo tablet taken orally once daily after breakfast for 8 weeks. |
|
|