Helicobacter Pylori Eradication With Berberine Quadruple Therapy Versus Clarithromycin Quadruple Therapy

Dyspepsia Clinical Trial

Official title:

Helicobacter Pylori Eradication With Berberine Hydrochloride, Lansoprazole, Amoxicillin and Bismuth Versus Clarithromycin Bismuth, Lansoprazole and Amoxicillin: A Randomized, Open-label, Non-inferiority, Phase Ⅳ Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02633930
• Other study ID #: KY20151203-2
• Status: Completed
• Phase: Phase 4
• First received: December 15, 2015
• Last updated: January 15, 2017
• Start date: December 2015
• Est. completion date: August 2016

Study information

• Verified date: January 2017
• Source: Xijing Hospital of Digestive Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims at evaluating efficacy and safety of berberine-containing quadruple therapy(berberine, lansoprazole, bismuth and amoxicillin) versus clarithromycin-containing quadruple therapy (clarithromycin,lansoprazole, bismuth and amoxicillin) in H. pylori eradication. It is hypothesized that berberine-containing quadruple therapy is non-inferior to clarithromycin-containing quadruple therapy. Patients with confirmed H. pylori positive status will be randomized to one of the treatments described above. At week 2 and 6 follow-up visits, a urea breath test(UBT) will be performed to confirm eradication.

Description:

The study will include three phases: screening, treatment and follow-up. Screening: this phase will last a maximum of 28 days and subjects eligibility will be evaluated after informed consent signature. Endoscopy and Urea Breath test will be performed in addition to the baseline routine evaluations.

Treatment: Subjects are randomly assigned to treatment and will be treated for 14 days. A randomization visit will take place on Day 0 and an end-of-treatment visit will take place between day 12 and 14.

Follow-up: includes two visits. approximately 14 days of treatment and 28 days after the end of treatment. Eradication of H. Pylori will be confirmed through urea breath test(UBT).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 566
• Est. completion date: August 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Age between 18~70,both gender.

2. Patients with upper gastrointestinal symptoms and with documented H.pylori infection.

3. Patients are willing to receive eradication treatment.

4. Women are eligible if they are not pregnant or nursing, and if they are of childbearing potential they are required to use medically acceptable contraception for the duration of the study and 30 days thereafter.

Exclusion Criteria:

1. Patients are excluded if they have previously used antibiotics to eradicate adequately recorded infection with H. pylori.

2. Contraindications to study drugs.

3. Substantial organ impairment, severe or unstable cardiopulmonary or endocrine disease.

4. Constant use of anti-ulcer drugs ( including taking proton-pump. inhibitors(PPI) within 2 weeks before the [13C] urea breath test), antibiotics or bismuth complexes (more than 3 times /1 month before screening)

5. Pregnant or lactating women.

6. Underwent upper gastrointestinal Surgery.

7. Patients with Barrett esophageal or highly atypical hyperplasia, have symptom of dysphagia.

8. Evidence of bleeding or iron efficiency anemia.

9. A history of malignancy.

10. Drug or alcohol abuse history in the past 1 year.

11. Systemic use of corticosteroids, non steroidal anti-inflammatory drugs, anticoagulants, platelet aggregation inhibitors (except the use of aspirin for less than 100 mg/d).

12. Enrolled in other clinical trials in the past 3 months.

Related Conditions & MeSH terms

• Dyspepsia
• Gastritis
• Peptic Ulcer

Intervention

Drug:
• Berberine
: given for 14 days at a dose of berberine 100 mg 3 tablets TID, lansoprazole 30 mg BID, amoxicillin 500 mg 2 capsules BID, and colloidal bismuth tartrate capsule55 mg 4 capsules BID
• clarithromycin
Clarithromycin-containing quadruple therapy group 500 mg 1 tablet BID plus amoxicillin 500 mg 2 capsules BID, lansoprazole 30mg 1tablet BID, and colloidal bismuth tartrate capsule55 mg 4 capsules BID.
• Bismuth
Bismuth:given for 14 days at a dose of colloidal bismuth tartrate capsule 55 mg 4 capsules BID, lansoprazole30 mg BID, amoxicillin 500 mg 2 capsules BID, and clarithromycin 500 mg 1 tablet BID or given for 14 days at a dose of colloidal bismuth tartrate capsule 55 mg 4 capsules BID, lansoprazole30 mg BID, amoxicillin 500 mg 2 capsules BID, and berberine 100 mg 3 tablet TID
• Lansoprazole
Lansoprazole 30mg 1tablet BID plus amoxicillin 500 mg 2 capsules BID, clarithromycin 500 mg 1 tablet BID, and colloidal bismuth tartrate capsule 55 mg 4 capsules BID or berberine 100 mg 3 tablets TID given to berberine-containing quadruple therapy group or clarithromycin-containing quadruple therapy group
• amoxicillin
Amoxicillin 500 mg 2 capsules BID plus lansoprazole 30mg 1tablet BID, clarithromycin 500 mg 1 tablet BID, and colloidal bismuth tartrate capsule 55 mg 4 capsules BID or berberine 100 mg 3 tablets TID as a dose given for clarithromycin-containing quadruple therapy or berberine-containing quadruple therapy.

Locations

Country	Name	City	State
China	Xijing Hospital of Digestive Disease	Xi'an	Shanxi
China	Xijing Hospital of Digestive Diseases	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital of Digestive Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	helicobacter pylori eradication	The primary end point of this study is H.pylori eradication,established by negative [13C] urea breath test 28 days after the end of eradication.	28 days after treatment
Secondary	symptoms effective rates	Evaluation effective rate of symptoms 2 weeks of treatment and 4 weeks after the end of treatment.; Symptom effective rate =(total score before treatment - total score after treatment)/total score before treatment x 100%. Total score = frequency + severity.; Frequency score is calculated by all the frequency of heartburn, reflux, abdominal pain, and flatulence. Severity is accumulated by the degree of symptoms described above, which is divided to 4 degree as 0 presenting none, and 3 presenting most severe	14 days of treatment, and 28 days after treatment
Secondary	adverse events	Participants with Adverse Events as a Measure of Safety and Tolerability.The common side effects of the study include headache, dizziness, skin rash, other gastrointestinal disorders, pyrexia, cough and back pain.	14 days of treatment, and 28 days after treatment