Duodenal Ulcer Due to Helicobacter PyloriPhase 4NCT03342456

The Efficacy and Safety of Ilaprazole/Doxycycline-based Bismuth-containing Quadruple Therapy on Hp Infected Duodenal Ulcers

A Phase 4 study testing Doxycycline Hyclate Enteric-Coated Capsules, Amoxicillin Capsules and Ilaprazole Enteric-Coated Tablets in people with Duodenal Ulcer Due to Helicobacter Pylori, run by The Third Xiangya Hospital of Central South University at 7 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Duodenal Ulcer Due to Helicobacter Pylori
What is being tested?: Doxycycline Hyclate Enteric-Coated Capsules, Amoxicillin Capsules and Ilaprazole Enteric-Coated Tablets
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 184 participants
Where: 7 sitesChina
Study dates: 13 Dec 2017to 20 Sep 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 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

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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.

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

China7 sites

Xiangya Hospital of Central South University
Changsha, Hunan, 410008
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013
The First Affiliated Hospital of University of South China
Hengyang, Hunan, 421001
Loudi central hospital
Loudi, Hunan, 417000
Shaoyang Central Hospital
Shaoyang, Hunan, 422000
The Affiliated Hospital Of YongZhou Vocational Technical College
Yongzhou, Hunan, 425000

Other trials in China

About this study

Official title: The Efficacy and Safety of Ilaprazole/Doxycycline-based Bismuth-containing Quadruple Therapy on Hp Infected Duodenal Ulcers: A Randomized, Parallel-controlled Multi-center Study

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.

Conditions: Duodenal Ulcer Due to Helicobacter Pylori
Being tested: Doxycycline Hyclate Enteric-Coated Capsules, Amoxicillin Capsules, Ilaprazole Enteric-Coated Tablets, Furazolidone Tablets, Potassium Citrate Tablets
Keywords: Helicobacter pylori eradication, Duodenal Ulcer, Ilaprazole/Doxycycline-based Bismuth-containing quadruple therapy
Medical subject headings: Duodenal Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Doxycycline Hyclate Enteric-Coated CapsulesDrug
group 1,0.1g*10 capsules/box, produced by Yung Shin Pharm.Ind.(Kunshan) Co.,Ltd.
Amoxicillin CapsulesDrug
group 2,0.5g*24 capsules/box, produced by United Laboratories（Zhuhai）
Ilaprazole Enteric-Coated TabletsDrug
group 1 and group 2,5mg*6 capsules/box, produced by Livzon Pharmaceutical Group Inc
Furazolidone TabletsDrug
group 1 and group 2,0.1g*100 tablets/bottle,produced by Shanxi Yunpeng Pharmaceutical co.,Ltd.
Potassium Citrate TabletsDrug
group 1 and group 2,110mg*40 tablets/bottle,produced by Livzon Pharmaceutical Group Inc

Study groups in NCT03342456
Study group	Role	What they receive
group 1	Experimental	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 Receives: Drug: Doxycycline Hyclate Enteric-Coated Capsules; Drug: Ilaprazole Enteric-Coated Tablets; Drug: Furazolidone Tablets; Drug: Potassium Citrate Tablets
group 2	Active comparator	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 Receives: Drug: Amoxicillin Capsules; Drug: Ilaprazole Enteric-Coated Tablets; Drug: Furazolidone Tablets; Drug: Potassium Citrate Tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

The eradication rate of H. pylori infection
Evaluated by 13C-urea breath test (13C-UBT), 14C-urea breath test (14C-UBT), or Pathological examination.
Measured: Visit period 3 (After day 56)

Secondary outcomes (6)

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.
Measured: Visit period 2 (day 28±1)
Number of duodenal ulcer(s)
Confirmed by endoscope.
Measured: Visit period 2 (day 28±1)
Maximum diameter of duodenal ulcer(s)
Confirmed by endoscope (cm).
Measured: Visit period 2 (day 28±1)
Surrounding inflammation and(or) erosion of duodenal ulcer(s)
Confirmed by endoscope.
Measured: Visit period 2 (day 28±1)
Incidence of bleeding
Confirmed by endoscope.
Measured: 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.).
Measured: Screening period (day -3~0), Visit period 1 (day 14±1), Visit period 2 (day 28±1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Dec 201720 Sep 2019

First posted17 Nov 2017
Study start13 Dec 2017
Primary completion20 Jun 2019
Study completion20 Sep 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Duodenal Ulcer Due to Helicobacter PyloriStudies of the same condition, open and under way.
More trials run by The Third Xiangya Hospital of Central South UniversityThe 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: 184 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03342456
Sponsor's protocol ID: xucanxia2000
Status last verified: Feb 2022
First submitted: 30 Oct 2017
Last updated: 2 Mar 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Efficacy and Safety of Ilaprazole/Doxycycline-based Bismuth-containing Quadruple Therapy on Hp Infected Duodenal Ulcers: A Randomized, Parallel-controlled Multi-center Study
ClinicalTrials.gov ID: NCT03342456
Acronym / sponsor ID: xucanxia2000
Conditions: Duodenal Ulcer Due to Helicobacter Pylori
Keywords: Helicobacter pylori eradication, Duodenal Ulcer, Ilaprazole/Doxycycline-based Bismuth-containing quadruple therapy
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 184 participants (actual)
Lead sponsor: The Third Xiangya Hospital of Central South UniversityUniversity, hospital or other
Collaborators: Livzon Pharmaceutical Group Inc., Yung Shin Pharm. Ind. Co., Ltd.
Study start: 13 Dec 2017 (actual)
Primary completion: 20 Jun 2019 (actual)
Study completion: 20 Sep 2019 (actual)
First posted: 17 Nov 2017 (actual)
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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
group 1	Experimental	Drug: Doxycycline Hyclate Enteric-Coated Capsules, Drug: Ilaprazole Enteric-Coated Tablets, Drug: Furazolidone Tablets, Drug: Potassium Citrate Tabletsweek1 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
group 2	Active comparator	Drug: Amoxicillin Capsules, Drug: Ilaprazole Enteric-Coated Tablets, Drug: Furazolidone Tablets, Drug: Potassium Citrate TabletsAmoxicillin 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

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (14 listed)

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.

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
Doxycycline Hyclate Enteric-Coated Capsulesgroup 1,0.1g*10 capsules/box, produced by Yung Shin Pharm.Ind.(Kunshan) Co.,Ltd.	Drug	group 1
Amoxicillin Capsulesgroup 2,0.5g*24 capsules/box, produced by United Laboratories（Zhuhai）	Drug	group 2
Ilaprazole Enteric-Coated Tabletsgroup 1 and group 2,5mg*6 capsules/box, produced by Livzon Pharmaceutical Group Inc	Drug	group 1, group 2
Furazolidone Tabletsgroup 1 and group 2,0.1g*100 tablets/bottle,produced by Shanxi Yunpeng Pharmaceutical co.,Ltd.	Drug	group 1, group 2
Potassium Citrate Tabletsgroup 1 and group 2,110mg*40 tablets/bottle,produced by Livzon Pharmaceutical Group Inc	Drug	group 1, group 2

Primary outcome

The eradication rate of H. pylori infection
Time frame: Visit period 3 (After day 56)
Evaluated by 13C-urea breath test (13C-UBT), 14C-urea breath test (14C-UBT), or Pathological examination.

6 secondary outcomes

The healing rate of duodenal ulcer(s)
Time frame: Visit period 2 (day 28±1)
Number of duodenal ulcer(s)
Time frame: Visit period 2 (day 28±1)
Maximum diameter of duodenal ulcer(s)
Time frame: Visit period 2 (day 28±1)
Surrounding inflammation and(or) erosion of duodenal ulcer(s)
Time frame: Visit period 2 (day 28±1)
Incidence of bleeding
Time frame: Visit period 2 (day 28±1)
Improvement of gastric symptoms
Time frame: Screening period (day -3~0), Visit period 1 (day 14±1), Visit period 2 (day 28±1)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
Individual participant dataSharing planned: No

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.

JINGSHU CHI principal investigator

The Third Xiangya Hospital of Central South University

XIAOMING LIU principal investigator

The Third Xiangya Hospital of Central South University

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 14 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: finished, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The eradication rate of H. pylori infection (time frame: Visit period 3 (After day 56)). 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 NCT03342456.

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 2 Mar 2022.