Helicobacter Pylori InfectionPhase 4NCT02894268
Doxycycline- and Furazolidone-containing Quadruple Regimen is Superior of Tailored Therapy
A Phase 4 study testing Doxycycline, Furazolidone and Esomeprazole in people with Helicobacter Pylori Infection, run by Sir Run Run Shaw Hospital at 1 site in China.
Trial summary
Doxycycline- and Furazolidone-containing Quadruple Regimen can be a successful rescue treatment for Helicobacter pylori Infection patients after Failure of several therapy. It is superior of tailored therapy as rescue treatment for helicobacter pylori Infection after failure of several therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Doxycycline, Furazolidone and Esomeprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Feb 2016to Dec 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A positive 13 C-urea breath test
- Formal H.pylori treatment more than two times
- Age >18 years
Who cannot join
- Bismuth compounds, acid inhibitor, or antibiotics during 4 weeks before the patient is enrolled
- Allergic to the medications
- Upper gastrointestinal surgery history
- Serious heart insufficiency, liver insufficiency, renal insufficiency and other serious medical problems
- Evidence of blood dyscrasia
- Pregnant and lactating women
- Can't express his complain correctly and can't cooperate with the researcher
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sir Run Run Shaw Hospital,Zhejiang University
Hangzhou, Zhejiang, 310000
Weiling Hu, Attending, +86153-9705-9751, ringwh@163.com
Weiling Hu, Atrending
About this study
Official title: Doxycycline- and Furazolidone-containing Quadruple Regimen is Superior of Tailored Therapy as Rescue Treatment for Helicobacter Pylori Infection After Failure of Several Therapy
Doxycycline- and Furazolidone-containing Quadruple Regimen can be a successful rescue treatment for Helicobacter pylori Infection patients after Failure of several therapy. It is superior of tailored therapy as rescue treatment for helicobacter pylori Infection after failure of several therapy.
Read the detailed description
This study is a prospective, multiple centers, randomized trial. Patients who had failed in previous H. pylori eradication treatment that more than two times will be enrolled in Sir Run Run Shaw Hospital.
Pretreatment H. pylori status will be defined by a positive 13 C-urea breath test (13 C-UBT). Patients who had received bismuth compounds, acid inhibitor, or antibiotics during 4 weeks before 13 C-UBT are excluded. Other exclusion criteria included upper gastrointestinal surgery, malignancy, and evidence of blood dyscrasia.
After the patient is enrolled the patient will sign the informed consent and receive gastroscopy. More than four biopsy will be given including two in antrum and two in gastric body. One pair of biopsy sample will be sent for the pathology and the other pair is used for H.pylori culture and antibiotics sensitivity. After we get the result of antibiotics sensitivity the patient will be divided randomly into two groups, Regimen A, Regimen B.
The Regimen A includes esomeprazole (E) 20 mg, doxycycline (D) 100mg, furazolidone (F) 100 mg, and colloidal bismuth subcitrate (B) 100 mg . All drugs are taken twice a day for 14 days. The Regimen B includes two antibiotics based on antibiotic sensitivity of helicobacter pylori culture, colloidal bismuth subcitrate (B) 100 mg, esomeprazole (E) 20 mg. The esomeprazole and bismuth are taken half an hour before a meal and antibiotics after the meal.
All patients are asked to quit smoking and drinking and forbid eating foods rich in tyramine (e.g., chicken, cheese, pickles, lentils, beans) and seafood during and in 1 week after the treatment.
Patients will be followed up at the 1st day, 14th day, and 4 weeks after the treatment, respectively, and all side effects will be collected.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Doxycycline, Furazolidone, Esomeprazole, Colloidal Bismuth Subcitrate, Sensitivity antibiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxycyclineDrug
Also called Vibramycin
Doxycycline 100g po bid
FurazolidoneDrug
Also called Giarlan
Furazolidone 100mg po bid
EsomeprazoleDrug
Also called Nexium
Esomeprazole 20mg po bid
Colloidal Bismuth SubcitrateDrug
Also called PIDI
Bismuth 20mg po bid
Sensitivity antibioticsDrug
Two antibiotics based on antibiotic sensitivity of H.pylori culture, including amoxicillin, clarithromycin, metronidazole, levofloxacin, tetracycline and furazolidone.
| Study group | Role | What they receive |
|---|---|---|
| Regimen A | Experimental | esomeprazole (E) 20 mg, doxycycline (D) 100mg, furazolidone (F) 100 mg, and colloidal bismuth subcitrate (B) 100 mg Receives: Drug: Doxycycline; Drug: Furazolidone; Drug: Esomeprazole; Drug: Colloidal Bismuth Subcitrate |
| Regimen B | Active comparator | two sensitivity antibiotics based on antibiotic sensitivity of helicobacter pylori culture, colloidal bismuth subcitrate (B) 100 mg, esomeprazole (E) 20 mg Receives: Drug: Esomeprazole; Drug: Colloidal Bismuth Subcitrate; Drug: Sensitivity antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
H. pylori eradication rate
Repeat 13-Urea breath test 42 days after H.pylori eradication
Measured: 42 days after start of therapy
Secondary outcomes (3)
Clinical response as measured by Number of participants whose symptoms disappear or improve after eradication treatment
Number of participants whose symptoms disappear or improve after eradication treatment.
Measured: 14 days and 42 days after H.pylori eradication
Side effects
Adverse Events That Are Related to Eradication Treatment
Measured: 14 days after start of therapy
Adherence rate
Number of patients who take at least 80% drugs
Measured: 14 days after start of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study startFeb 2016
- Primary completionOct 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- More trials run by Sir Run Run Shaw HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weiling Hu, MD,PhD, Sir Run Run Shaw Hospital
- Investigators
- Weiling Hu, Attending, Principal investigator, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02894268
- Sponsor's protocol ID
- 20160513-1
- Status last verified
- Sep 2018
- First submitted
- 25 Aug 2016
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Zhang Y, Gao W, Cheng H, Zhang X, Hu F. Tetracycline- and furazolidone-containing quadruple regimen as rescue treatment for Helicobacter pylori infection: a single center retrospective study. Helicobacter. 2014 Oct;19(5):382-6. doi: 10.1111/hel.12143. Epub 2014 May 21.
PubMed 24849129Ciccaglione AF, Cellini L, Grossi L, Manzoli L, Marzio L. A Triple and Quadruple Therapy with Doxycycline and Bismuth for First-Line Treatment of Helicobacter pylori Infection: A Pilot Study. Helicobacter. 2015 Oct;20(5):390-6. doi: 10.1111/hel.12209. Epub 2015 Mar 20.
PubMed 25801708
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Doxycycline- and Furazolidone-containing Quadruple Regimen is Superior of Tailored Therapy as Rescue Treatment for Helicobacter Pylori Infection After Failure of Several Therapy
- ClinicalTrials.gov ID
- NCT02894268
- Acronym / sponsor ID
- 20160513-1
- Conditions
- Helicobacter Pylori Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 9 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Doxycycline- and Furazolidone-containing Quadruple Regimen can be a successful rescue treatment for Helicobacter pylori Infection patients after Failure of several therapy. It is superior of tailored therapy as rescue treatment for helicobacter pylori Infection after failure of several therapy.
Detailed description
This study is a prospective, multiple centers, randomized trial. Patients who had failed in previous H. pylori eradication treatment that more than two times will be enrolled in Sir Run Run Shaw Hospital.
Pretreatment H. pylori status will be defined by a positive 13 C-urea breath test (13 C-UBT). Patients who had received bismuth compounds, acid inhibitor, or antibiotics during 4 weeks before 13 C-UBT are excluded. Other exclusion criteria included upper gastrointestinal surgery, malignancy, and evidence of blood dyscrasia.
After the patient is enrolled the patient will sign the informed consent and receive gastroscopy. More than four biopsy will be given including two in antrum and two in gastric body. One pair of biopsy sample will be sent for the pathology and the other pair is used for H.pylori culture and antibiotics sensitivity. After we get the result of antibiotics sensitivity the patient will be divided randomly into two groups, Regimen A, Regimen B.
The Regimen A includes esomeprazole (E) 20 mg, doxycycline (D) 100mg, furazolidone (F) 100 mg, and colloidal bismuth subcitrate (B) 100 mg . All drugs are taken twice a day for 14 days. The Regimen B includes two antibiotics based on antibiotic sensitivity of helicobacter pylori culture, colloidal bismuth subcitrate (B) 100 mg, esomeprazole (E) 20 mg. The esomeprazole and bismuth are taken half an hour before a meal and antibiotics after the meal.
All patients are asked to quit smoking and drinking and forbid eating foods rich in tyramine (e.g., chicken, cheese, pickles, lentils, beans) and seafood during and in 1 week after the treatment.
Patients will be followed up at the 1st day, 14th day, and 4 weeks after the treatment, respectively, and all side effects will be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regimen A | Experimental | Drug: Doxycycline, Drug: Furazolidone, Drug: Esomeprazole, Drug: Colloidal Bismuth Subcitrateesomeprazole (E) 20 mg, doxycycline (D) 100mg, furazolidone (F) 100 mg, and colloidal bismuth subcitrate (B) 100 mg |
| Regimen B | Active comparator | Drug: Esomeprazole, Drug: Colloidal Bismuth Subcitrate, Drug: Sensitivity antibioticstwo sensitivity antibiotics based on antibiotic sensitivity of helicobacter pylori culture, colloidal bismuth subcitrate (B) 100 mg, esomeprazole (E) 20 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A positive 13 C-urea breath test
- Formal H.pylori treatment more than two times
- Age >18 years
Key exclusion criteria (7 listed)
- Bismuth compounds, acid inhibitor, or antibiotics during 4 weeks before the patient is enrolled
- Allergic to the medications
- Upper gastrointestinal surgery history
- Serious heart insufficiency, liver insufficiency, renal insufficiency and other serious medical problems
- Evidence of blood dyscrasia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DoxycyclineAlso: VibramycinDoxycycline 100g po bid | Drug | Regimen A |
| FurazolidoneAlso: GiarlanFurazolidone 100mg po bid | Drug | Regimen A |
| EsomeprazoleAlso: NexiumEsomeprazole 20mg po bid | Drug | Regimen A, Regimen B |
| Colloidal Bismuth SubcitrateAlso: PIDIBismuth 20mg po bid | Drug | Regimen A, Regimen B |
| Sensitivity antibioticsTwo antibiotics based on antibiotic sensitivity of H.pylori culture, including amoxicillin, clarithromycin, metronidazole, levofloxacin, tetracycline and furazolidone. | Drug | Regimen B |
Primary outcome
H. pylori eradication rate
Time frame: 42 days after start of therapy
Repeat 13-Urea breath test 42 days after H.pylori eradication
3 secondary outcomes
Clinical response as measured by Number of participants whose symptoms disappear or improve after eradication treatment
Time frame: 14 days and 42 days after H.pylori eradication
Side effects
Time frame: 14 days after start of therapy
Adherence rate
Time frame: 14 days after start of therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
- Background: PubMed 24849129Zhang Y, Gao W, Cheng H, Zhang X, Hu F. Tetracycline- and furazolidone-containing quadruple regimen as rescue treatment for Helicobacter pylori infection: a single center retrospective study. Helicobacter. 2014 Oct;19(5):382-6. doi: 10.1111/hel.12143. Epub 2014 May 21.
- Results publication: PubMed 25801708Ciccaglione AF, Cellini L, Grossi L, Manzoli L, Marzio L. A Triple and Quadruple Therapy with Doxycycline and Bismuth for First-Line Treatment of Helicobacter pylori Infection: A Pilot Study. Helicobacter. 2015 Oct;20(5):390-6. doi: 10.1111/hel.12209. Epub 2015 Mar 20.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weiling Hu, Attending principal investigator
Sir Run Run Shaw Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Doxycycline, Furazolidone and Esomeprazole in people with Helicobacter Pylori Infection, run by Sir Run Run Shaw Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ning Dai, Chief (+86138-6745-7664, 2267454962@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
H. pylori eradication rate (time frame: 42 days after start of therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02894268, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2018.