A Phase 3 Randomised Controlled Trial to Evaluate Efficacy and Safety of Anaprazole in Patients With Duodenal Ulcers.

Last updated: December 30, 2019
Sponsor: Sihuan Pharmaceutical Holdings Group Ltd.
Overall Status: Active - Not Recruiting

Phase

3

Condition

Colic

Stomach Discomfort

Treatment

N/A

Clinical Study ID

NCT04215653
3571-DU-3001
  • Ages 18-70
  • All Genders

Study Summary

A phase 3,double-blinded, double dummy, parallel, non-inferiority, randomised controlled multicenter trial to evaluate efficacy and safety of 4 weeks treatment of Anaprazole 20mg QD compared with rabeprazole 10mg QD in patients with duodenal ulcers.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 18-70 years, male and female

  2. Has endoscopic diagnosis of active duodenal ulcer(s) (A1 or A2 stage) within 7 daysprior to randomization

  3. 1 or 2 ulcers, 3-15 mm in diameter.

  4. Signed informed concent form

Exclusion

Exclusion Criteria:

  1. Has malignancy ulcer or malignancy ulcer not excluded, compouned ulcer, stress ulcer,esophageal erosion and ulcer, reflux esophagitis, Zollinger-Ellison syndrome.

  2. Has esophageal and gastric varices;

  3. With severe compliaction, such as pyloric obstruction, bleeding (Forrest I, IIa andIIb) or perforation, and etc;

  4. Has gastric ulcer, or has history of inflammatory bowel disease (such as Crohn'sdisease or ulcerative colitis);

  5. Has undergone surgical resection or partly resection of esophageal, stomach orduodenum;

  6. Has used Proton Pump Inhibitors(PPIs) within 5 days prior to randomization, orcontinuous more than 3 days of use of Proton Pump Inhibitors within 2 weeks prior torandomization;

  7. Has been treated with triple or quandruple Helicobacter pylori eradication therapyincluded PPIs within 28 days prior to randomization;

  8. Current use the drugs (such as systemic glucocorticoids, non steroid anti-inflammatorydrugs, or anticoagulation drugs) which may induce ulcer or ulceric bleeding orcontinuous more than 3 days of use the drugs (such as systemic glucocorticoids, nonsteroid anti-inflammatory drugs, or anticoagulation drugs) within 28 days prior torandomization;

  9. Laboratory tests performed in screning stage revealed Alanine aminotransferase (ALT)or aspartate aminotransferase (AST): > 1.5 upper limit of normal (ULN);

  10. Laboratory tests performed in screning stage revealed thyroid stimulating hormone (TSH) or free triiodothyronine (FT3) and free thyroxin ( FT4) : > upper limit ofnormal (ULN);

  11. Woman in pregnancy or lactation period;

  12. Plan for pregancy or not willing to contracept with reliable contraception methodduring study period and within 90 days after the final time of investigational drugadministratio;

  13. Have alcohol abuse or drug abuse 1 years prior to screening;

  14. Has hypersensitivity or allergy to investigatory drug, comparatory drug or relatedsupplements;

  15. Has participated or been participating other clinical trials(non-interventional studyis excluded);

  16. Has an uncotroled disease, such as has a history of significant central nervous system (CNS), cardiovascular, pulmonary, hepatic, renal, gastrointestinal, or mental orpsychological disorders with drug treatment that,in the opinion of the investigator,would not be suitable for participating this clinical trial.

  17. Has a history of malignancy or was treated or not treated for malignancy within 5years before randomization (the participant may be included in the study if he/she hascured cutaneous basal cell carcinoma), no matter if there is evidence for localrelapse or metastasis;

  18. Laboratory tests performed in screning stage revealed estimated Glomerular filtrationrate(eGFR) <80 mL/min/1.73 m2 calculated by Modification of Diet in RenalDisease(MDRD) equation;

  19. In the opinion of the investigator, the patients with other situation would not besuitable for participating this clinical trial.

Study Design

Total Participants: 448
Study Start date:
January 20, 2020
Estimated Completion Date:
February 28, 2021