Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05577468
Other study ID # NC822101
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date October 30, 2022
Est. completion date September 30, 2023

Study information

Verified date January 2024
Source Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is a multicenter, randomized, double-blind, double-dummy, phase III study to evaluate the efficacy and safety of tegoprazan versus esomeprazole-containing bismuth quadruple therapy in patients infected with Helicobacter pylori in China. Screening phase: After signing the informed consent form, subjects will be determined for Helicobacter pylori infection by 13^C-urea breath test (UBT),histological testing and bacterial culture during the screening period. Subjects who meet all screening criteria will be randomized in a 1:1 ratio to receive the tegoprazan-containing bismuth quadruple therapy (hereinafter referred to as the tegoprazan group) or esomeprazole-containing bismuth quadruple therapy (hereinafter referred to as the esomeprazole group). Treatment phase: Subjects will receive relevant study medication starting on Day 1 of the treatment period for 14 days. Follow-up phase: Within 29+7 days after the last study drug treatment, subjects will return to the study site for efficacy and safety assessments. 13^C-UBT detection will be performed in this follow-up visit to determine the Hp infection status of the subjects after treatment.


Recruitment information / eligibility

Status Completed
Enrollment 561
Est. completion date September 30, 2023
Est. primary completion date September 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - 1) Subjects who volunteer to sign the written informed consent form approved by the Ethics Committee and agree to participate in this study prior to the initiation of any study procedures. 2) Subjects who are able to understand and follow the protocol requirements and agree to participate in all the study visits. 3) Males or females =18 years old and =70 years old. 4) In the screening stage, subjects are confirmed Hp infection by 13^C-urea breath test , histology test and bacterial culture, and then the investigators judge that Hp eradication treatment is required. 5) Subjects who agree to use appropriate medical method for contraception during the course of the study (not including women in medically sterile state) Exclusion Criteria: - 1) Subjects received Hp eradication treatment previously. 2) Subjects who have participated in other clinical studies within 4 weeks before screening, except for the following two situations: - The study which the subject is participating or participated in is a non-interventional study (e.g. observational study or questionnaire survey); Subject had signed the informed consent form in that study, but withdrew from that study prior to the start of any treatment. - Subjects who have participated in the [NC821604] study and have demonstrated ulcer healing may participate in this study. 3) Subjects who participated in the planning and execution of this study. 4) Women who are pregnant or breastfeeding. 5) Subjects with known allergy to tegoprazan, esomeprazole, penicillins or other ß-lactams, macrolide antibiotics or bismuth (including any related excipients). If a skin sensitivity test (skin test) is required, it should be carried out at Visit 1 according to routine medical practice. 6) Subjects with a history of drug (including but not limited to opioids) abuse or alcohol abuse within 1 year before the screening visit. 7) Subjects with Zollinger-Ellison syndrome. 8) Subjects who have previously undergone surgery or operations that may affect gastric acid secretion or drug absorption, 9) Subjects with "warning" symptoms such as painful swallowing, severe dysphagia, bleeding, weight loss, anemia, or blood in the stool that may indicate malignant lesions of the gastrointestinal tract, unless the possibility of malignant lesions is ruled out by endoscopy. 10) Subjects with a history of malignant tumor within 5 years before screening 11) Subjects who cannot undergo upper gastrointestinal endoscopy. 12) Subjects whose upper gastrointestinal endoscopy demonstrates acute upper gastrointestinal bleeding, active gastric ulcer or duodenal ulcer, acute gastric mucosal injury or duodenal mucosal injury. 13) Subjects with uncontrolled and unstable hepatic, renal, cardiovascular, respiratory, gastrointestinal, endocrine, hematologic, central nervous system or mental diseases as judged by investigators, in which participation in the study may affect the interpretation of their safety or research results. 14) Subjects who plan to be hospitalized for surgical treatment during the study. 15) Subjects who have taken H2 receptor antagonists or PPI within 14 days before the 13C-urea breath test during the screening period, or those who have taken antibacterial drugs, bismuth and certain Chinese medicines with antibacterial effects within 28 days before the 13C-urea breath test during the screening period. 16) Subjects who need to use the prohibited drugs listed in the protocol. 17) Subjects with any of the following laboratory test abnormalities at screening: - AST > upper limit of normal (ULN); - ALT > ULN; - Total bilirubin > 1.2 × ULN; - Creatinine > 1.5 × ULN; 18) Subjects with clinically significant electrocardiogram (ECG) abnormalities at the screening as judged by investigators. 19) Human immunodeficiency virus (HIV) antibody positive, hepatitis B virus (HBV) surface antigen positive or hepatitis C virus (HCV) antibody positive confirmed by tests. 20) Judged by the investigator, there are other conditions compromising the subject's eligibility for this study.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Tegoprazan
tegoprazan-containing bismuth quadruple therapy or Esomeprazole-containing bismuth quadruple therapy; Route of administration: oral;

Locations

Country Name City State
China Peking University Third Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of All Participants With Successful Helicobacter Pylori (H.Pylori) Eradication Percentage of all patients with Hp eradication determined by a 13^C-urea breath test after study treatment. Day 29+7 days following the completion of treatment(duration of treatment was 2 weeks)
Secondary Percentage of Participants With Successful Helicobacter Pylori (H.Pylori) Eradication in Participants With a Clarithromycin-resistant Strain of H Pylori at Baseline Day 29+7 days following the completion of treatment( duration of treatment was 2 weeks)
Secondary Percentage of Participants With Successful Helicobacter Pylori (H.Pylori) Eradication in Participants With a Clarithromycin-sensitive Strain of H Pylori at Baseline Day 29+7 days following the completion of treatment(duration of treatment was 2 weeks)
Secondary Percentage of Participants With Successful Helicobacter Pylori (H.Pylori) Eradication in Participants With a Amoxicillin-resistant Strain of H Pylori at Baseline Day 29+7 days following the completion of treatment(duration of treatment was 2 weeks)
Secondary Percentage of Participants With Successful Helicobacter Pylori (H.Pylori) Eradication in Participants With a Amoxicillin-sensitive Strain of H Pylori at Baseline Day 29+7 days following the completion of treatment(duration of treatment was 2 weeks)
See also
  Status Clinical Trial Phase
Recruiting NCT05061732 - Helicobacter Pylori Eradication and Follow-up Phase 4
Completed NCT03779074 - Comparing the Efficacy of Hybrid, High-dose Dual and Bismuth Quadruple Therapies Phase 3
Completed NCT06076681 - A Study to Evaluate Preliminary Helicobacter Pylori Eradication After Multiple Doses of TNP-2198 Capsules Combined With Rabeprazole Sodium Enteric-coated Tablets, or Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules Phase 1/Phase 2
Recruiting NCT05329636 - Auto Fecal Microbial Transplant Post Helicobacter Pylori Antibiotic Therapy Phase 1/Phase 2
Recruiting NCT05065138 - Comparison of Helicobacter Pylori Eradication Effect Before and After Training of Gastroenterologists N/A
Completed NCT05049902 - Bismuth-containing Quadruple Therapy for Helicobacter Pylori Eradication Phase 4
Not yet recruiting NCT06200779 - Tailored vs. Empirical Helicobacter Pylori Infection Treatment Phase 4
Not yet recruiting NCT06037122 - Efficacy of Low-dose Vonoprazan for Helicobacter Pylori Eradication
Completed NCT04617613 - Comparing Different Regimens for Eradication of Helicobacter Pylori in Kuwait Phase 4
Completed NCT02873247 - Standardize Communication With General Practitioner & Patient for Improved Eradication of Helicobacter Pylori
Completed NCT02557932 - Comparison of 7-day PPI-based Standard Triple Therapy and 10-day Bismuth Quadruple Therapy for H. Pylori Eradication Phase 3
Withdrawn NCT02552641 - Food Effect on the Eradication Rate of H. Pylori With Triple Therapy With Esomeprazole Phase 4
Recruiting NCT02249546 - Efficacy of Acetylcysteine-containing Triple Therapy in the First Line of Helicobacter Pylori Infection Phase 4
Completed NCT01933659 - Anti-H. Pylori Effect of Deep See Water Phase 3
Unknown status NCT01464060 - 14-day Quadruple Hybrid vs. Concomitant Therapies for Helicobacter Pylori Eradication Phase 4
Completed NCT00841490 - Oral H. Pylori Prevalence in Intellectually & Developmentally Disabled Adults N/A
Recruiting NCT05549115 - Susceptibility-Guided Sequential Therapy for Helicobacter Pylori Infection N/A
Recruiting NCT05728424 - One vs Two Weeks Treatment for H.Pylori Eradication A RANDOMIZED NON-INFERIORITY PLACEBO CONTROLLED TRIAL Phase 3
Recruiting NCT05997433 - Efficacy of 7-day Versus 14-day Bismuth Quadruple Therapy for the Eradication of Helicobacter Pylori(SHARE2302) N/A
Completed NCT04708405 - The Relationship Between Helicobacter Pylori Infection and Inflammatory Bowel Diseases: A Real-life Observation