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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-070399 | Other Identifier | Japic |
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The purpose of this study is to examine the safety and efficacy of rebamipide by once daily intracolonial administration at 0 (placebo), 60, 150, or 300 mg for 6 weeks in patients with active ulcerative colitis, who are being treated with oral aminosalicylic acid (ASA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | 0mg rebamipide |
|
| 2 | Experimental | 60mg rebamipide |
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| 3 | Experimental | 150mg rebamipide |
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| 4 | Experimental | 300mg rebamipide |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rebamipide | Drug | 0, 60, 150, 300mg of rebamipide per day for 6 weeks into colon |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Improvement Rate (Number of Subjects Showing Clinical Improvement/Number of Subjects Evaluated x 100) | Definition of clinical improvement: a decrease of Disease Activity Index [DAI] score for "rectal bleeding" to either 0 or 1 point and a decrease of ≥1 point in the DAI score for "findings on endoscopy" from the baseline | Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Remission (Number of Subjects Showing Remission/Number of Subjects Evaluated x 100) | Definition of remission: a decrease of the total DAI scores for "rectal bleeding" and "findings on endoscopy" to 0 points | Week 6 |
| Mean Change From Baseline in Total DAI Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katsuhisa Saito | Division of New Product Evaluation and Development | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chubu Region | Japan | |||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Rebamipide 60 mg | Once daily intracolonial administration at a dose of 60 mg for 6 weeks |
| FG001 | Rebamipide 150 mg | Once daily intracolonial administration at a dose of 150 mg for 6 weeks |
| FG002 | Rebamipide 300 mg | Once daily intracolonial administration at a dose of 300 mg for 6 weeks |
| FG003 | Placebo | Once daily intracolonial administration of placebo for 6 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Full Analysis Set: subjects who received at least one dose of the study drug and for whom postdose efficacy data were obtained
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| ID | Title | Description |
|---|---|---|
| BG000 | Rebamipide 60 mg | Once daily intracolonial administration at a dose of 60 mg for 6 weeks |
| BG001 | Rebamipide 150 mg | Once daily intracolonial administration at a dose of 150 mg for 6 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Clinical Improvement Rate (Number of Subjects Showing Clinical Improvement/Number of Subjects Evaluated x 100) | Definition of clinical improvement: a decrease of Disease Activity Index [DAI] score for "rectal bleeding" to either 0 or 1 point and a decrease of ≥1 point in the DAI score for "findings on endoscopy" from the baseline | Full Analysis Set: subjects who received at least one dose of the study drug and for whom postdose efficacy data were obtained | Posted | Number | 95% Confidence Interval | percentage of participants | Week 6 |
|
Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks
Safety Set comprised subjects who received the study drug at least once.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rebamipide 60 mg | Once daily intracolonial administration at a dose of 60 mg for 6 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis ulcerative | Gastrointestinal disorders | MedDRA Ver.11.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Otsuka Pharmaceutical Co., LTD. | +81-3-6361-7366 | CL_OPCJ_RDA_Team@otsuka.jp |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C052785 | rebamipide |
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DAI measures disease activity through assessment of 4 items/subscales: stool frequency, rectal bleeding, findings on endoscopy, and physician's global assessment. Each item of the score is assessed on a 4-point scale from 0 to 3; the total score ranges from 0 to 12 with a higher score representing greater severity. A negative change in mean score indicates improvement. |
| Baseline and Week 6 |
| Percentage of Subjects Showing Improvement in Each DAI Subscore | DAI measures disease activity through assessment of 4 items/subscales: stool frequency, rectal bleeding, findings on endoscopy, and physician's global assessment. Each item of the score is assessed on a 4-point scale from 0 to 3 with a higher score representing greater severity. A negative change from baseline indicates improvement. | Baseline and week 6 |
| Mean Change From Baseline in Total Endoscopic Index (EI) Score | The index consisted of 4 subscales: granulation scattering reflected light, vascular pattern, vulnerability of mucosa, and mucosal damage. Each subscale was scored on a scale of 0 to 4 and the total score (the sum of all 4 subscores) ranges from 0 to 12, higher scores indicate more severe disease. | Baseline and Week 6 |
| Chugoku Region |
| Japan |
| Hokkaido Region | Japan |
| Kinki Region | Japan |
| Kyushu Region | Japan |
| Lack of Efficacy |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| BG002 | Rebamipide 300 mg | Once daily intracolonial administration at a dose of 300 mg for 6 weeks |
| BG003 | Placebo | Once daily intracolonial administration of placebo for 6 weeks |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Once daily intracolonial administration at a dose of 150 mg for 6 weeks
| OG002 | Rebamipide 300 mg | Once daily intracolonial administration at a dose of 300 mg for 6 weeks |
| OG003 | Placebo | Once daily intracolonial administration of placebo for 6 weeks |
|
|
| Secondary | Clinical Remission (Number of Subjects Showing Remission/Number of Subjects Evaluated x 100) | Definition of remission: a decrease of the total DAI scores for "rectal bleeding" and "findings on endoscopy" to 0 points | Full Analysis Set: subjects who received at least one dose of the study drug and for whom postdose efficacy data were obtained | Posted | Number | 95% Confidence Interval | percentage of participants | Week 6 |
|
|
|
| Secondary | Mean Change From Baseline in Total DAI Score | DAI measures disease activity through assessment of 4 items/subscales: stool frequency, rectal bleeding, findings on endoscopy, and physician's global assessment. Each item of the score is assessed on a 4-point scale from 0 to 3; the total score ranges from 0 to 12 with a higher score representing greater severity. A negative change in mean score indicates improvement. | Full Analysis Set: subjects who received at least one dose of the study drug and for whom postdose efficacy data were obtained | Posted | Mean | Standard Deviation | score on a scale | Baseline and Week 6 |
|
|
|
| Secondary | Percentage of Subjects Showing Improvement in Each DAI Subscore | DAI measures disease activity through assessment of 4 items/subscales: stool frequency, rectal bleeding, findings on endoscopy, and physician's global assessment. Each item of the score is assessed on a 4-point scale from 0 to 3 with a higher score representing greater severity. A negative change from baseline indicates improvement. | Full Analysis Set: subjects who received at least one dose of the study drug and for whom postdose efficacy data were obtained | Posted | Number | percentage of participants | Baseline and week 6 |
|
|
|
| Secondary | Mean Change From Baseline in Total Endoscopic Index (EI) Score | The index consisted of 4 subscales: granulation scattering reflected light, vascular pattern, vulnerability of mucosa, and mucosal damage. Each subscale was scored on a scale of 0 to 4 and the total score (the sum of all 4 subscores) ranges from 0 to 12, higher scores indicate more severe disease. | Full Analysis Set: subjects who received at least one dose of the study drug and for whom postdose efficacy data were obtained | Posted | Mean | Standard Deviation | score on a scale | Baseline and Week 6 |
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 22 |
| 35 |
| EG001 | Rebamipide 150 mg | Once daily intracolonial administration at a dose of 150 mg for 6 weeks | 0 | 29 | 2 | 29 | 20 | 29 |
| EG002 | Rebamipide 300 mg | Once daily intracolonial administration at a dose of 300 mg for 6 weeks | 0 | 29 | 0 | 29 | 18 | 29 |
| EG003 | Placebo | Once daily intracolonial administration of placebo for 6 weeks | 0 | 31 | 1 | 31 | 22 | 31 |
| Necrotising fasciitis | Infections and infestations | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Vertigo positional | Ear and labyrinth disorders | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Asthenopia | Eye disorders | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Cheilitis | Gastrointestinal disorders | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Colitis ulcerative | Gastrointestinal disorders | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Rectal haemorrhage | Gastrointestinal disorders | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Stomach discomfort | Gastrointestinal disorders | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Anal haemorrhage | Gastrointestinal disorders | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Rectal tenesmus | Gastrointestinal disorders | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Gastrointestinal motility disorder | Gastrointestinal disorders | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Gastrointestinal inflammation | Gastrointestinal disorders | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Feeling hot | General disorders | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Malaise | General disorders | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Hepatic function abnormal | Hepatobiliary disorders | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Food allergy | Immune system disorders | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Seasonal allergy | Immune system disorders | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Furuncle | Infections and infestations | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Herpes simplex | Infections and infestations | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Hordeolum | Infections and infestations | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Enteritis infectious | Infections and infestations | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Basophil count increased | Investigations | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Blood albumin decreased | Investigations | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Blood cholesterol increased | Investigations | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Blood lactate dehydrogenase increased | Investigations | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Blood potassium decreased | Investigations | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Blood potassium increased | Investigations | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Blood triglycerides increased | Investigations | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Blood urea decreased | Investigations | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Blood uric acid increased | Investigations | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Eosinophil count decreased | Investigations | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Eosinophil count increased | Investigations | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Glucose urine present | Investigations | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Haematocrit decreased | Investigations | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Blood urine present | Investigations | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Haemoglobin decreased | Investigations | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Liver function test abnormal | Investigations | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Lymphocyte count abnormal | Investigations | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Lymphocyte count decreased | Investigations | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Monocyte count increased | Investigations | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Neutrophil count increased | Investigations | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Red blood cell count decreased | Investigations | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Red blood cell count increased | Investigations | MedDRA Ver.11.0 | Non-systematic Assessment |
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| White blood cell count decreased | Investigations | MedDRA Ver.11.0 | Non-systematic Assessment |
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| White blood cell count increased | Investigations | MedDRA Ver.11.0 | Non-systematic Assessment |
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| White blood cells urine positive | Investigations | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Platelet count increased | Investigations | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Protein urine present | Investigations | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Urine ketone body present | Investigations | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Blood alkaline phosphatase increased | Investigations | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Sacroiliitis | Musculoskeletal and connective tissue disorders | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Pharyngeal erythema | Respiratory, thoracic and mediastinal disorders | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Eczema asteatotic | Skin and subcutaneous tissue disorders | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Night sweats | Skin and subcutaneous tissue disorders | MedDRA Ver.11.0 | Non-systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA Ver.11.0 | Non-systematic Assessment |
|
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| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
|
| Rectal bleeding |
|
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| Findings on endoscopy |
|
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| Physician's global assessment |
|
|