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| Name | Class |
|---|---|
| Livzon Pharmaceutical Group Inc. | INDUSTRY |
| Yung Shin Pharm. Ind. Co., Ltd. | INDUSTRY |
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Helicobacter pylori (Hp) infection is one of the important causes of gastrointestinal diseases, including gastritis, peptic ulcer, and malignancies, nd the eradication of Hp can effectively cure or prevent these diseases. Now, owing to the increasingly serious antibiotic resistance, Hp eradication rate is, however, becoming decreased. In order to improve the eradication rate of Hp, clinicians pay great attention to choose more effective treatment.
Ilaprazole Enteric-Coated Tablets is a new generation of proton pump inhibitor (PPI). Previous research found that Ilaprazole had a more prolonged half-life and higher suppression of gastric acid secretion. In addition, its metabolism is not significantly influenced by CYP2C19, compared to the available PPIs. Doxycycline is in the tetracycline antibiotic class, has a stronger antibacterial force than tetracycline and its antibacterial spectrum is basically the same as tetracycline and doxycycline, so far, it is not widely used. Preliminary observations showed that Ilaprazole/Doxycycline-based quadruple therapy was effective in treating Hp infection, with less adverse reactions and good compliance with patients.
In this study, a multi-center, randomized, parallel controlled trial will be conducted in 7 hospitals in Hunan Province, China, to observe the clinical efficacy and safety of the Bismuth-containing quadruple therapy with Ilaprazole, Doxycycline, Furazolidone and Bismuth Potassium Citrate in the treatment of Hp infected duodenal ulcer. It is expected to complete 200 effective cases, including 100 cases in the experimental group and 100 cases in the control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group 1 | Experimental | week1 to week2:Doxycycline Hyclate Enteric-Coated Capsules 0.1g,orally,twice daily,taken with meals, Ilaprazole Enteric-Coated Tablets 5mg,orally,twice daily, Furazolidone Tablets 0.1g,orally,twice daily,taken with meals, Bismuth Potassium Citrate Tablets 220mg,orally,twice daily week3 to week4:Ilaprazole Enteric-Coated Tablets 5mg,orally,once daily |
|
| group 2 | Active Comparator | Amoxicillin Capsules 1g,orally,twice daily,taken with meals, Ilaprazole Enteric-Coated Tablets 5mg,orally,twice daily, Furazolidone Tablets 0.1g,orally,twice daily,taken with meals, Bismuth Potassium Citrate Tablets 220mg,orally,twice daily. week3 to week4:Ilaprazole Enteric-Coated Tablets 5mg,orally,once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doxycycline Hyclate Enteric-Coated Capsules | Drug | group 1,0.1g*10 capsules/box, produced by Yung Shin Pharm.Ind.(Kunshan) Co.,Ltd. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The eradication rate of H. pylori infection | Evaluated by 13C-urea breath test (13C-UBT), 14C-urea breath test (14C-UBT), or Pathological examination. | Visit period 3 (After day 56) |
| Measure | Description | Time Frame |
|---|---|---|
| The healing rate of duodenal ulcer(s) | Duodenal ulcer healing rate is defined as the percentage of participants with complete healing of ulcer (according to Sakita-Fukutomi classification) under endoscope. | Visit period 2 (day 28±1) |
| Number of duodenal ulcer(s) |
| Measure | Description | Time Frame |
|---|---|---|
| Degree of pain | Evaluated by clinical symptoms scores
|
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| JINGSHU CHI | The Third Xiangya Hospital of Central South University | Principal Investigator |
| XIAOMING LIU | The Third Xiangya Hospital of Central South University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangya Hospital of Central South University | Changsha | Hunan | 410008 | China | ||
| The Second Xiangya Hospital of Central South University |
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| Amoxicillin Capsules | Drug | group 2,0.5g*24 capsules/box, produced by United Laboratories(Zhuhai) |
|
| Ilaprazole Enteric-Coated Tablets | Drug | group 1 and group 2,5mg*6 capsules/box, produced by Livzon Pharmaceutical Group Inc |
|
| Furazolidone Tablets | Drug | group 1 and group 2,0.1g*100 tablets/bottle,produced by Shanxi Yunpeng Pharmaceutical co.,Ltd. |
|
| Potassium Citrate Tablets | Drug | group 1 and group 2,110mg*40 tablets/bottle,produced by Livzon Pharmaceutical Group Inc |
|
Confirmed by endoscope. |
| Visit period 2 (day 28±1) |
| Maximum diameter of duodenal ulcer(s) | Confirmed by endoscope (cm). | Visit period 2 (day 28±1) |
| Surrounding inflammation and(or) erosion of duodenal ulcer(s) | Confirmed by endoscope. | Visit period 2 (day 28±1) |
| Incidence of bleeding | Confirmed by endoscope. | Visit period 2 (day 28±1) |
| Improvement of gastric symptoms | Improvement is defined as the total change from baseline symptoms scores of Symptom Rating Scale(Includidng 9 items: Pain in day, Pain in night, Burning in day, Burning in night, Acid reflux in day, Acid reflux in night, Nausea and vomiting, Belching, Abdominal distension. Depending on severity and frequency, scale ranges from 0-3 points.). | Screening period (day -3~0), Visit period 1 (day 14±1), Visit period 2 (day 28±1) |
| Screening period (day -3~0), Visit period 1 (day 14±1), Visit period 2 (day 28±1) |
| Degree of burning | Evaluated by clinical symptoms scores
| Screening period (day -3~0), Visit period 1 (day 14±1), Visit period 2 (day 28±1) |
| Degree of acid reflux | Evaluated by clinical symptoms scores
| Screening period (day -3~0), Visit period 1 (day 14±1), Visit period 2 (day 28±1) |
| Degree of nausea and vomiting | Evaluated by clinical symptoms scores Nausea and vomiting 0 point: No nausea. 1 point: Occasionally and briefly. 2 points: Frequent nausea, vomiting. 3 points: Continuous nausea, frequent vomiting. | Screening period (day -3~0), Visit period 1 (day 14±1), Visit period 2 (day 28±1) |
| Degree of belching | Evaluated by clinical symptoms scores Belching 0 point: No belching. 1 point: Occasionally. 2 points: Frequently. 3 points: Continuously, and affect normal activities. | Screening period (day -3~0), Visit period 1 (day 14±1), Visit period 2 (day 28±1) |
| Degree of abdominal distension | Evaluated by clinical symptoms scores Abdominal distension 0 point: No abdominal distension. 1 point: Occasionally. 2 points: Obvious abdominal distension. 3 points: Severe abdominal distension, and affect normal activities. | Screening period (day -3~0), Visit period 1 (day 14±1), Visit period 2 (day 28±1) |
| Symptom disappearance time | Visit period 1 (day 14±1), Visit period 2 (day 28±1) |
| Changsha |
| Hunan |
| 410011 |
| China |
| The Third Xiangya Hospital of Central South University | Changsha | Hunan | 410013 | China |
| The First Affiliated Hospital of University of South China | Hengyang | Hunan | 421001 | China |
| Loudi central hospital | Loudi | Hunan | 417000 | China |
| Shaoyang Central Hospital | Shaoyang | Hunan | 422000 | China |
| The Affiliated Hospital Of YongZhou Vocational Technical College | Yongzhou | Hunan | 425000 | China |
| ID | Term |
|---|---|
| D004381 | Duodenal Ulcer |
| ID | Term |
|---|---|
| D010437 | Peptic Ulcer |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| D000658 | Amoxicillin |
| D005664 | Furazolidone |
| D019357 | Potassium Citrate |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009581 | Nitrofurans |
| D009574 | Nitro Compounds |
| D023303 | Oxazolidinones |
| D010080 | Oxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D005663 | Furans |
| D019343 | Citric Acid |
| D002951 | Citrates |
| D014233 | Tricarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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