Status:
COMPLETED
The Efficacy and Safety of Ilaprazole/Doxycycline-based Bismuth-containing Quadruple Therapy on Hp Infected Duodenal Ulcers
Lead Sponsor:
The Third Xiangya Hospital of Central South University
Collaborating Sponsors:
Livzon Pharmaceutical Group Inc.
Yung Shin Pharm. Ind. Co., Ltd.
Conditions:
Duodenal Ulcer Due to Helicobacter Pylori
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
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 pr...
Eligibility Criteria
Inclusion
- Has endoscopic evidence of active duodenal ulcer(within a week before participate), accompanying or not accompanied with abdominal pain/abdominal discomfort, acid, heartburn, abdominal distention, belching and other corresponding symptoms.
- The diameter of the ulcer is 0.3 to 2.0cm, and the number is less than or equal 2.
- Has evidence(s) of Hp infection. (13C-UBT/14C-UBT/Pathological test)
- Has a history of antiacid medication, but has been stopped for more than 2 weeks.
- Has not used antibiotics and (or) bismuth agents in nearly four weeks.
- Understand and be willing to participate in this clinical trial.
Exclusion
- Has been taking ulcer medications, such as non-steroidal anti-inflammatory drugs, adrenal corticosteroids etc.
- Has allergic and idiosyncratic responses to the tested drugs and (or) control drugs.
- Has a diagnosis of duodenal carcinelcosis or a duodenal ulcer can not rule out the the possibility of malignancy (patients with gastrointestinal mucosal epithelial mild atypical hyperplasia are not ruled out) or compound ulcers.
- Has severe or progressive dysphagia, weight loss, gastrointestinal bleeding or other alarm symptoms.
- Has esophageal or gastric varices, Zollinger-Ellison syndrome, or serious complications such as pyloric obstruction, active bleeding in the endoscope; esophageal erosion or ulcers, other digestive serious diseases, Such as Crohn's disease, ulcerative colitis.
- Has a history of gastric acid suppression surgery, esophageal surgery, or digestive organ surgery, with the exception of simple suture of perforation.
- Is pregnant, breastfeeding or has a family planning during whole trail.
- Has serious cardiovascular, pulmonary, hepatic, renal, hematological or endocrine disease with uncontrolled condition.
- Has participated in other clinical trials within 3 months prior to the trial.
- Is required to use the prescribed anti-ulcer drug during the trial.
- Has a history of drug and (or) alcohol abuse.
- Has restriction on sodium, with metabolic alkalosis and (or) hypocalcemia.
- Has a long-term use of clopidogrel.
- Has other reasons for not to participating in clinical trials.
Key Trial Info
Start Date :
December 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 20 2019
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT03342456
Start Date
December 13 2017
End Date
September 20 2019
Last Update
March 2 2022
Active Locations (7)
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1
Xiangya Hospital of Central South University
Changsha, Hunan, China, 410008
2
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China, 410011
3
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China, 410013
4
The First Affiliated Hospital of University of South China
Hengyang, Hunan, China, 421001