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NCT Number: NCT03342456

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

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.

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Key information

Conditions

Duodenal Ulcer Due to Helicobacter Pylori Digestive System Diseases Duodenal Diseases Duodenal Ulcer Gastrointestinal Diseases Intestinal Diseases Peptic Ulcer Stomach Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Second Xiangya Hospital of Central South University, Changsha, Hunan, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Doxycycline Hyclate Enteric-Coated Capsules

Drug

group 1,0.1g*10 capsules/box, produced by Yung Shin Pharm.Ind.(Kunshan) Co.,Ltd.

Amoxicillin Capsules

Drug

group 2,0.5g*24 capsules/box, produced by United Laboratories（Zhuhai）

Ilaprazole Enteric-Coated Tablets

Drug

group 1 and group 2,5mg*6 capsules/box, produced by Livzon Pharmaceutical Group Inc

Furazolidone Tablets

Drug

group 1 and group 2,0.1g*100 tablets/bottle,produced by Shanxi Yunpeng Pharmaceutical co.,Ltd.

Potassium Citrate Tablets

Drug

group 1 and group 2,110mg*40 tablets/bottle,produced by Livzon Pharmaceutical Group Inc

Primary outcomes

  1. 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.

Secondary outcomes

  1. The healing rate of duodenal ulcer(s)

    Time frame: Visit period 2 (day 28±1)

    Duodenal ulcer healing rate is defined as the percentage of participants with complete healing of ulcer (according to Sakita-Fukutomi classification) under endoscope.

  2. Number of duodenal ulcer(s)

    Time frame: Visit period 2 (day 28±1)

    Confirmed by endoscope.

  3. Maximum diameter of duodenal ulcer(s)

    Time frame: Visit period 2 (day 28±1)

    Confirmed by endoscope (cm).

  4. Surrounding inflammation and(or) erosion of duodenal ulcer(s)

    Time frame: Visit period 2 (day 28±1)

    Confirmed by endoscope.

  5. Incidence of bleeding

    Time frame: Visit period 2 (day 28±1)

    Confirmed by endoscope.

  6. Improvement of gastric symptoms

    Time frame: Screening period (day -3~0), Visit period 1 (day 14±1), Visit period 2 (day 28±1)

    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.).

Other outcomes

  1. Degree of pain

    Time frame: Screening period (day -3~0), Visit period 1 (day 14±1), Visit period 2 (day 28±1)

    Evaluated by clinical symptoms scores

    • Pain in day 0 point: No pain. 1 point: Mild pain, do not affect daily life and work, do not have to take medicines. 2 points: Obvious pain,partly affect daily life and work, or have to take medicines. 3 points: Severe pain, must rest, taking medicine is ineffective
    • Pain in night 0 point: No pain. 1 point: Mild pain, do not affect daily life and work, do not have to take medicines. 2 points: Obvious pain,partly affect daily life and work, or have to take medicines. 3 points: Severe pain, must rest, taking medicine or eat is ineffective

  2. Degree of burning

    Time frame: Screening period (day -3~0), Visit period 1 (day 14±1), Visit period 2 (day 28±1)

    Evaluated by clinical symptoms scores

    • Burning in day 0 point: No burning. 1 point: Occasionally. 2 points: Frequently and duration prolonged. 3 points: Continuously, use antacid to alleviate briefly.
    • Burning in night 0 point: No burning. 1 point: Occasionally. 2 points: Frequently and duration prolonged. 3 points: Continuously, use antacid to alleviate briefly.

  3. Degree of acid reflux

    Time frame: Screening period (day -3~0), Visit period 1 (day 14±1), Visit period 2 (day 28±1)

    Evaluated by clinical symptoms scores

    • Acid reflux in day 0 point: No acid reflux. 1 point: Occasionally. 2 points: One to two times a day. 3 points: Several times a day.
    • Acid reflux in night 0 point: No acid reflux. 1 point: Occasionally. 2 points: One to two times a day. 3 points: Several times a day.

  4. Degree of nausea and vomiting

    Time frame: Screening period (day -3~0), Visit period 1 (day 14±1), Visit period 2 (day 28±1)

    Evaluated by clinical symptoms scores Nausea and vomiting 0 point: No nausea. 1 point: Occasionally and briefly. 2 points: Frequent nausea, vomiting. 3 points: Continuous nausea, frequent vomiting.

  5. Degree of belching

    Time frame: Screening period (day -3~0), Visit period 1 (day 14±1), Visit period 2 (day 28±1)

    Evaluated by clinical symptoms scores Belching 0 point: No belching. 1 point: Occasionally. 2 points: Frequently. 3 points: Continuously, and affect normal activities.

  6. Degree of abdominal distension

    Time frame: Screening period (day -3~0), Visit period 1 (day 14±1), Visit period 2 (day 28±1)

    Evaluated by clinical symptoms scores Abdominal distension 0 point: No abdominal distension. 1 point: Occasionally. 2 points: Obvious abdominal distension. 3 points: Severe abdominal distension, and affect normal activities.

  7. Symptom disappearance time

    Time frame: Visit period 1 (day 14±1), Visit period 2 (day 28±1)

Sponsors and collaborators

Lead sponsor

The Third Xiangya Hospital of Central South University

Other

Collaborators

  • Livzon Pharmaceutical Group Inc.
  • Yung Shin Pharm. Ind. Co., Ltd.

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 17, 2017
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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