Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01667718
Other study ID # rjkls2012011
Secondary ID
Status Completed
Phase Phase 4
First received June 5, 2012
Last updated December 12, 2012
Start date May 2012
Est. completion date October 2012

Study information

Verified date December 2012
Source Shanghai Jiao Tong University School of Medicine
Contact n/a
Is FDA regulated No
Health authority Renji Hospital, Shanghai Jiaotong University, School of Medicine:China
Study type Interventional

Clinical Trial Summary

To examine and compare the efficacy of 2 week Levofloxacin-containing therapies with and without Bismuth for H.pylori treatment.


Description:

The success rate of the standard triple therapy for H. pylori infection is decreasing recently.Fluoroquinolone has been proposed to replace clarithromycin as an alternative in the treatment. However prevalence of H.pylori resistance to Levofloxacin has increased rapidly in our area. The purpose of this study is to observe the efficacy of 14 day Levofloxacin triple therapy-based, bismuth-containing quadruple therapy for H.pylori treatment.


Recruitment information / eligibility

Status Completed
Enrollment 161
Est. completion date October 2012
Est. primary completion date October 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- patients who presented with upper gastrointestinal symptoms and endoscopically proven H.pylori-positive functional dyspepsia and scarred peptic ulcer

Exclusion Criteria:

- patients with peptic ulcer, previous H.pylori eradication therapy, previous gastric surgery, pregnancy, lactation, major systemic diseases, receipt of anti-secretory therapy, antibiotics or bismuth in the preceding 4 weeks, or allergy to any one of the medications

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Bismuth
Bismuth 220mg b.i.d for 2 weeks
Lansoprazole
Lansoprazole 30 mg b.i.d.for 2 weeks
Levo?oxacin
Levo?oxacin 0.5 q.d. for 2 weeks
Amoxicillin
Amoxicillin 1 g b.i.d. for 2 weeks

Locations

Country Name City State
China Shanghai Jiao-Tong University School of Medicine Renji Hospital Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary eradication rate of Helicobacter pylori 2 months Yes
See also
  Status Clinical Trial Phase
Completed NCT04656730 - Effect of STW5 (Iberogast ®) and STW5-II (Iberogast N®) on Transit and Tolerance of Intestinal Gas Phase 4
Completed NCT04464369 - Functional Dyspepsia: Validation of the Leuven Postprandial Distress Scale (LPDS) in a Placebo-controlled Trial Phase 4
Completed NCT01671670 - Acupuncture for Patients With Function Dyspepsia Phase 2/Phase 3
Completed NCT00987805 - Efficacy of Banhasasim-tang on Functional Dyspepsia Phase 4
Completed NCT00761358 - To Verify the Efficacy of Z-338 in Subjects With Functional Dyspepsia Phase 3
Completed NCT00693407 - Study of Endogenous Inhibitory Modulation During Gastric and Somatic Stimulation N/A
Recruiting NCT01240096 - Mirtazapine Versus Placebo in Functional Dyspepsia Phase 4
Recruiting NCT04540549 - Effects of Exercise on Functional Dyspepsia Based on Rome IV N/A
Recruiting NCT03652571 - Nortriptyline for the Treatment of Functional Dyspepsia Phase 3
Recruiting NCT06068114 - Gastric Pathophysiology in Diabetes
Recruiting NCT03825692 - International Clinical Study of Zhizhu Kuanzhong Capsule Phase 4
Not yet recruiting NCT04548011 - Acupuncture of Different Treatment Frequency on Improving Quality of Life in Patients With Functional Dyspepsia N/A
Terminated NCT02567578 - A Trial to Evaluate the Efficacy and Safety of YH12852 in Patients With Functional Dyspepsia Phase 2
Completed NCT03007433 - Assessment of GI Function to a Large Test Meal by Non-invasive Imaging N/A
Active, not recruiting NCT00990405 - Clinical Study to Evaluate the Efficacy and the Safety of Eradication Therapy for Helicobacter Pylori in Functional Dyspepsia Phase 4
Completed NCT00404534 - Helicobacter Eradication Relief of Dyspeptic Symptoms Phase 3
Completed NCT03043625 - Visceral Manipulation Treatment to Patients With Non-specific Neck Pain With Functional Dyspepsia N/A
Completed NCT03225248 - Efficacy and Safety of UI05MSP015CT in Functional Dyspepsia Phase 3
Recruiting NCT05587127 - Exposure-Based CBT for Avoidant/Restrictive Food Intake in Functional Dyspepsia N/A
Recruiting NCT01021475 - Does Visceral Manipulation Works in Treating Functional Dyspepsia? Phase 1