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

A Phase 3,Double-blinded, Double Dummy, Positive Drug, Parallel, Randomised Controlled Multicenter Trial to Evaluate Efficacy and Safety of Anaprazole Compared With Rabeprazole in Patients With Duodenal Ulcers.

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.

Study Overview

• Status: Unknown
• Conditions: Duodenal Ulcer，DU
• Intervention / Treatment: Drug: Anaprazole Sodium; Drug: Rabeprazole Placebo; Drug: Rabeprazole; Drug: Anaprazole Sodium Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 448
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 days prior to randomization
3. 1 or 2 ulcers, 3-15 mm in diameter.
4. Signed informed concent form

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 and IIb) or perforation, and etc；
4. Has gastric ulcer, or has history of inflammatory bowel disease (such as Crohn's disease or ulcerative colitis)；
5. Has undergone surgical resection or partly resection of esophageal, stomach or duodenum；
6. Has used Proton Pump Inhibitors(PPIs) within 5 days prior to randomization, or continuous more than 3 days of use of Proton Pump Inhibitors within 2 weeks prior to randomization；
7. Has been treated with triple or quandruple Helicobacter pylori eradication therapy included PPIs within 28 days prior to randomization；
8. Current use the drugs (such as systemic glucocorticoids, non steroid anti-inflammatory drugs, or anticoagulation drugs) which may induce ulcer or ulceric bleeding or continuous more than 3 days of use the drugs (such as systemic glucocorticoids, non steroid anti-inflammatory drugs, or anticoagulation drugs) within 28 days prior to randomization；
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 of normal (ULN)；
11. Woman in pregnancy or lactation period；
12. Plan for pregancy or not willing to contracept with reliable contraception method during study period and within 90 days after the final time of investigational drug administratio；
13. Have alcohol abuse or drug abuse 1 years prior to screening；
14. Has hypersensitivity or allergy to investigatory drug, comparatory drug or related supplements；
15. Has participated or been participating other clinical trials(non-interventional study is excluded)；
16. Has an uncotroled disease, such as has a history of significant central nervous system (CNS), cardiovascular, pulmonary, hepatic, renal, gastrointestinal, or mental or psychological 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 5 years before randomization (the participant may be included in the study if he/she has cured cutaneous basal cell carcinoma), no matter if there is evidence for local relapse or metastasis；
18. Laboratory tests performed in screning stage revealed estimated Glomerular filtration rate（eGFR） <80 mL/min/1.73 m2 calculated by Modification of Diet in Renal Disease(MDRD) equation；
19. In the opinion of the investigator, the patients with other situation would not be suitable for participating this clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Anaprazole Sodium + Rabeprazole Placebo; administered orally once every 30-60 minutes before breakfast for 4 weeks	Drug: Anaprazole Sodium; administered orally once every 30-60 minutes before breakfast for 4 weeks; Drug: Rabeprazole Placebo; administered orally once every 30-60 minutes before breakfast for 4 weeks
Active Comparator: Rabeprazole +Anaprazole Sodium Placebo; administered orally once every 30-60 minutes before breakfast for 4 weeks	Drug: Rabeprazole; administered orally once every 30-60 minutes before breakfast for 4 weeks; Drug: Anaprazole Sodium Placebo; administered orally once every 30-60 minutes before breakfast for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The endoscopic healing rate of duodenal ulcers at week 4, evaluated by blinded independency central reading.	The endoscopic ulcer healing rate is defined as the percentage of patients healed (complete healing and significant response) in whom the endoscopic response of duodenal ulcers at week 4 has been evaluated by blinded independency central reading.	Treatment of 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The endoscopic healing rate of duodenal ulcers at week 4, evaluated by investigator reading.	The endoscopic ulcer healing rate is defined as the percentage of patients healed (complete healing and significant response) in whom the endoscopic response of duodenal ulcers at week 4 has been evaluated by investigators.	Treatment of 4 weeks

Collaborators and Investigators

• Sponsor: Sihuan Pharmaceutical Holdings Group Ltd.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 20, 2020
• Primary Completion (Anticipated): February 15, 2021
• Study Completion (Anticipated): February 28, 2021

Study Registration Dates

• First Submitted: December 30, 2019
• First Submitted That Met QC Criteria: December 30, 2019
• First Posted (Actual): January 2, 2020

Study Record Updates

• Last Update Posted (Actual): January 2, 2020
• Last Update Submitted That Met QC Criteria: December 30, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Stomach Diseases; Intestinal Diseases; Peptic Ulcer; Duodenal Diseases; Ulcer; Duodenal Ulcer; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Rabeprazole
• Other Study ID Numbers: 3571-DU-3001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No