A Phase 4 interventional study of Doxycycline Hyclate Enteric-Coated Capsules and Amoxicillin Capsules in Duodenal Ulcer Due to Helicobacter Pylori, sponsored by The Third Xiangya Hospital of Central South University. Completed at 7 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-03-02.
Sponsored by The Third Xiangya Hospital of Central South University · Phase 4, Interventional, and Treatment
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.
79 studies on the registry are indexed under Duodenal Ulcer; 5 are open to participants now.
This study's enrollment of 184 is below the median of 308 across 54 interventional studies indexed under Duodenal Ulcer.
Browse Duodenal Ulcer studies →The Third Xiangya Hospital of Central South University is the lead sponsor of 99 studies on the registry; 52 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Drug: Doxycycline Hyclate Enteric-Coated Capsules · Drug: Ilaprazole Enteric-Coated Tablets · Drug: Furazolidone Tablets · Drug: Potassium Citrate Tablets
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
Drug: Amoxicillin Capsules · Drug: Ilaprazole Enteric-Coated Tablets · Drug: Furazolidone Tablets · Drug: Potassium Citrate Tablets
group 1,0.1g\*10 capsules/box, produced by Yung Shin Pharm.Ind.(Kunshan) Co.,Ltd.
group 2,0.5g\*24 capsules/box, produced by United Laboratories（Zhuhai）
group 1 and group 2,5mg\*6 capsules/box, produced by Livzon Pharmaceutical Group Inc
group 1 and group 2,0.1g\*100 tablets/bottle,produced by Shanxi Yunpeng Pharmaceutical co.,Ltd.
group 1 and group 2,110mg\*40 tablets/bottle,produced by Livzon Pharmaceutical Group Inc
The eradication rate of H. pylori infection
Evaluated by 13C-urea breath test (13C-UBT), 14C-urea breath test (14C-UBT), or Pathological examination.
Time frame: Visit period 3 (After day 56)
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.
Time frame: Visit period 2 (day 28±1)
Number of duodenal ulcer(s)
Confirmed by endoscope.
Time frame: Visit period 2 (day 28±1)
Maximum diameter of duodenal ulcer(s)
Confirmed by endoscope (cm).
Time frame: Visit period 2 (day 28±1)
Surrounding inflammation and(or) erosion of duodenal ulcer(s)
Confirmed by endoscope.
Time frame: Visit period 2 (day 28±1)
Incidence of bleeding
Confirmed by endoscope.
Time frame: 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.).
Time frame: Screening period (day -3~0), Visit period 1 (day 14±1), Visit period 2 (day 28±1)
Degree of pain
Evaluated by clinical symptoms scores 1. Pain in day 0 point: No pain. 1 point: Mild pain, do not affect daily life and work, do not have to take medicines. 2 points: Obvious pain,partly affect daily life and work, or have to take medicines. 3 points: Severe pain, must rest, taking medicine is ineffective 2. Pain in night 0 point: No pain. 1 point: Mild pain, do not affect daily life and work, do not have to take medicines. 2 points: Obvious pain,partly affect daily life and work, or have to take medicines. 3 points: Severe pain, must rest, taking medicine or eat is ineffective
Time frame: 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 1. Burning in day 0 point: No burning. 1 point: Occasionally. 2 points: Frequently and duration prolonged. 3 points: Continuously, use antacid to alleviate briefly. 2. Burning in night 0 point: No burning. 1 point: Occasionally. 2 points: Frequently and duration prolonged. 3 points: Continuously, use antacid to alleviate briefly.
Time frame: 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 1. Acid reflux in day 0 point: No acid reflux. 1 point: Occasionally. 2 points: One to two times a day. 3 points: Several times a day. 2. Acid reflux in night 0 point: No acid reflux. 1 point: Occasionally. 2 points: One to two times a day. 3 points: Several times a day.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Screening period (day -3~0), Visit period 1 (day 14±1), Visit period 2 (day 28±1)
Symptom disappearance time
Time frame: Visit period 1 (day 14±1), Visit period 2 (day 28±1)
Plan to share: No
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Ran from Dec 2017 to primary completion in Jun 2019, 18 months.
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The Third Xiangya Hospital of Central South University