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To evaluate the healing rate and safety of Lafutidine in erosive esophagitis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lafutidine | Experimental | Lafutidine 20mg/day |
|
| Famotidine | Active Comparator | Famotidine 40mg/day |
|
| Omeprazole | Other | Omeprazole 20mg/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lafutidine | Drug | Lafutidine 20mg/day |
| |
| Famotidine |
| Measure | Description | Time Frame |
|---|---|---|
| Recovery Rates of Reflux Esophagitis | Recovery rates of reflux esophagitis on the Esophago Gastro Duodenoscopy test after 8 week treatment-FAS | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The Proportion of Days Without 'Cardinal Symptom' | The proportion of days without 'Cardinal symptom' after 4 or 8 week treatment-FAS 'Cardinal symptom': Burning sesation in the chest, Acid reflux, Heartburn including chest pain | 4 or 8 week |
| The Proportion of Daytimes Without 'Cardinal Symptom' |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sang Woo Lee | Korea University Ansan Hospital | Study Chair |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lafutidine | Lafutidine 20mg/day Lafutidine 10mg bid, po |
| FG001 | Famotidine | Famotidine 40mg/day Famotidine 20mg bid, po |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Drug |
Famotidine 40mg/day |
|
| Omeprazole | Drug | Omeprazole 20mg/day |
|
The proportion of daytimes without 'Cardinal symptom' after 4 or 8 week treatment-FAS 'Cardinal symptom': Burning sensation in the chest, Acid reflux, Heartburn including chest pain |
| 4 or 8 week |
| The Proportion of Nighttimes Without 'Cardinal Symptom' | The proportion of Nighttimes without 'Cardinal symptom' after 4 or 8 treatment-FAS 'Cardinal symptom': Burning sensation in the chest, Acid reflux, Heartburn including chest pain | 4 or 8 week |
| FG002 | Omeprazole | Omeprazole 20mg/day Omeprazole 20mg qd(daily), po |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Because of a Duplicated subject in Active comparator, One was excluded.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Lafutidine | Lafutidine 20mg/day Lafutidine: Lafutidine 20mg/day |
| BG001 | Famotidine | Famotidine 40mg/day Famotidine: Famotidine 40mg/day |
| BG002 | Omeprazole | Omeprazole 20mg/day Omeprazole: Omeprazole 20mg/day |
| BG003 | 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 |
| |||||||||||||||
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| 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 | Recovery Rates of Reflux Esophagitis | Recovery rates of reflux esophagitis on the Esophago Gastro Duodenoscopy test after 8 week treatment-FAS | Posted | Count of Participants | Participants | 8 weeks |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Proportion of Days Without 'Cardinal Symptom' | The proportion of days without 'Cardinal symptom' after 4 or 8 week treatment-FAS 'Cardinal symptom': Burning sesation in the chest, Acid reflux, Heartburn including chest pain | Missing = Lafutidine(5) , Omeprazole(1) | Posted | Mean | Standard Deviation | proportion of days | 4 or 8 week |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Proportion of Daytimes Without 'Cardinal Symptom' | The proportion of daytimes without 'Cardinal symptom' after 4 or 8 week treatment-FAS 'Cardinal symptom': Burning sensation in the chest, Acid reflux, Heartburn including chest pain | Missing = Lafutidine(5) , Omeprazole(1) | Posted | Mean | Standard Deviation | proportion of days | 4 or 8 week |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Proportion of Nighttimes Without 'Cardinal Symptom' | The proportion of Nighttimes without 'Cardinal symptom' after 4 or 8 treatment-FAS 'Cardinal symptom': Burning sensation in the chest, Acid reflux, Heartburn including chest pain | Missing = Lafutidine(5) , Omeprazole(1) | Posted | Mean | Standard Deviation | proportion of days | 4 or 8 week |
|
|
4 week, 8 week and 9 week
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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 | Lafutidine | Lafutidine 20mg/day Lafutidine 10mg bid, po | 0 | 165 | 36 | 165 | ||
| EG001 | Famotidine | Famotidine 40mg/day Famotidine 20mg bid, po | 0 | 162 | 30 | 162 | ||
| EG002 | Omeprazole | Omeprazole 20mg/day Omeprazole 20mg qd(daily), po | 3 | 167 | 34 | 167 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | During the treatment period, he got biopsy at the Dermatology for skin lesion on the left inguinal area, which he had 2 years ago. The result was basal cell carcinoma, but the physician judged that causality of this event with the IP was unlikely. |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | He had musculoskeletal pain because of a car accident, during the treatment period. The physician confirmed that this shoulder pain was caused by muscle tears, which he originally had, and judged that causality of this event with IP was unlikely. |
| |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment | Pregnancy After 1 month of the treatment peroid, she dropped out of the trial. About 7 months later, she gave birth to a healthy baby boy. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal distension | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
| ||
| constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| enteritis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastric ulcer | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastritis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastritis erosive | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal discomfort | Gastrointestinal disorders | Systematic Assessment |
| ||
| Breath odour | Gastrointestinal disorders | Systematic Assessment |
| ||
| Duodenitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Eructation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Flatulence | Gastrointestinal disorders | Systematic Assessment |
| ||
| Food poisoning | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastritis haemorrhagic | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrooesophageal reflux disease | Gastrointestinal disorders | Systematic Assessment |
| ||
| Haemorrhoids | Gastrointestinal disorders | Systematic Assessment |
| ||
| Toothache | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| Acute pyelonephritis | Infections and infestations | Systematic Assessment |
| ||
| Bronchopneumonia | Infections and infestations | Systematic Assessment |
| ||
| Cystitis | Infections and infestations | Systematic Assessment |
| ||
| Enterocolitis infectious | Infections and infestations | Systematic Assessment |
| ||
| Laryngitis | Infections and infestations | Systematic Assessment |
| ||
| Rhinitis | Infections and infestations | Systematic Assessment |
| ||
| Tinea cruris | Infections and infestations | Systematic Assessment |
| ||
| Tonsillitis | Infections and infestations | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Somnolence | Nervous system disorders | Systematic Assessment |
| ||
| Burning sensation | Nervous system disorders | Systematic Assessment |
| ||
| Carotid artery stenosis | Nervous system disorders | Systematic Assessment |
| ||
| Migraine | Nervous system disorders | Systematic Assessment |
| ||
| Paraesthesia | Nervous system disorders | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dysphonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Productive cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Chest pain | General disorders | Systematic Assessment |
| ||
| Chest discomfort | General disorders | Systematic Assessment |
| ||
| Sensation of foreign body | General disorders | Systematic Assessment |
| ||
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Blood bilirubin increased | Investigations | Systematic Assessment |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pruritus generalised | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Urticaria | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Acne | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Dermatitis contact | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Contusion | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Periorbital haematoma | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Systematic Assessment |
| ||
| Conjunctivitis allergic | Eye disorders | Systematic Assessment |
| ||
| Dry eye | Eye disorders | Systematic Assessment |
| ||
| Non-alcoholic steatohepatitis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Mixed incontinence | Renal and urinary disorders | Systematic Assessment |
| ||
| Erectile dysfunction | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Essential hypertension | Vascular disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manager of Clinical Research | Boryung Pharmaceuticals | +82-2-708-8069 | rainbowleo@boryung.co.kr |
| ID | Term |
|---|---|
| C076948 | lafutidine |
| D015738 | Famotidine |
| D009853 | Omeprazole |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D011725 | Pyridines |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
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| 30 years ~ 39 years |
|
| 40 years ~ 49 years |
|
| 50 years ~ 59 years |
|
| 60 years ~ 69 years |
|
| 70 years ~ 74 years |
|
| Male |
|
|
|
|
|