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A Phase 2 Randomised Controlled Trial to Evaluate Efficacy and Safety of Anaprazole in Patients With Duodenal Ulcers.

Primary Purpose

Duodenal Ulcer,DU

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Anaprazole Sodium
Anaprazole Sodium
Rabeprazole sodium
Sponsored by
Sihuan Pharmaceutical Holdings Group Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Duodenal Ulcer,DU

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age ≥18 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 other gastrointestinal disease (e.g.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);
  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, 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. In the opinion of the investigator, the patients with other situation would not be suitable for participating this clinical trial.

Sites / Locations

  • The Fisrst Affiliated Hospital of NanChang University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Anaprazole Sodium 20mg QD

Anaprazole Sodium 40mg QD

Rabeprazole sodium 10mg QD

Arm Description

administered orally once every 30-60 minutes before breakfast for 4 weeks

administered orally once every 30-60 minutes before breakfast for 4 weeks

administered orally once every 30-60 minutes before breakfast for 4 weeks

Outcomes

Primary Outcome Measures

The endoscopic healing rate of duodenal ulcers at week 4.
The endoscopic ulcer healing rate is defined as the percentage of patients with endoscopic ulcer healed evaluated by investigators.

Secondary Outcome Measures

Full Information

First Posted
August 5, 2020
Last Updated
August 5, 2020
Sponsor
Sihuan Pharmaceutical Holdings Group Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04503629
Brief Title
A Phase 2 Randomised Controlled Trial to Evaluate Efficacy and Safety of Anaprazole in Patients With Duodenal Ulcers.
Official Title
A Phase 2,Double-blinded, Double Dummy, Positive Drug, Parallel, Randomised Controlled Multicenter Trial to Evaluate Efficacy and Safety of Anaprazole in Patients With Duodenal Ulcers.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
October 9, 2018 (Actual)
Primary Completion Date
May 17, 2019 (Actual)
Study Completion Date
May 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sihuan Pharmaceutical Holdings Group Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A phase 2,double-blinded, double dummy, parallel, positive drug, randomised controlled multicenter trial to evaluate efficacy and safety of 4 weeks treatment of Anaprazole 20mg QD, 40mg QD compared with rabeprazole 10mg QD in patients with duodenal ulcers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Duodenal Ulcer,DU

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anaprazole Sodium 20mg QD
Arm Type
Experimental
Arm Description
administered orally once every 30-60 minutes before breakfast for 4 weeks
Arm Title
Anaprazole Sodium 40mg QD
Arm Type
Experimental
Arm Description
administered orally once every 30-60 minutes before breakfast for 4 weeks
Arm Title
Rabeprazole sodium 10mg QD
Arm Type
Active Comparator
Arm Description
administered orally once every 30-60 minutes before breakfast for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Anaprazole Sodium
Intervention Description
Anaprazole Sodium 20mg
Intervention Type
Drug
Intervention Name(s)
Anaprazole Sodium
Intervention Description
Anaprazole Sodium 40mg
Intervention Type
Drug
Intervention Name(s)
Rabeprazole sodium
Intervention Description
Rabeprazole sodium 10mg
Primary Outcome Measure Information:
Title
The endoscopic healing rate of duodenal ulcers at week 4.
Description
The endoscopic ulcer healing rate is defined as the percentage of patients with endoscopic ulcer healed evaluated by investigators.
Time Frame
Treatment of 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥18 years, male and female Has endoscopic diagnosis of active duodenal ulcer(s) (A1 or A2 stage) within 7 days prior to randomization 1 or 2 ulcers, 3-15 mm in diameter. Signed informed concent form Exclusion Criteria: Has malignancy ulcer or malignancy ulcer not excluded, compouned ulcer, stress ulcer, esophageal erosion and ulcer, reflux esophagitis, Zollinger-Ellison syndrome. Has esophageal and gastric varices; With severe compliaction, such as pyloric obstruction, bleeding (Forrest I, IIa and IIb) or perforation, and etc; Has other gastrointestinal disease (e.g.gastric ulcer), or has history of inflammatory bowel disease (such as Crohn's disease or ulcerative colitis); Has undergone surgical resection or partly resection of esophageal, stomach or duodenum; 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; Has been treated with triple or quandruple Helicobacter pylori eradication therapy included PPIs within 28 days prior to randomization; 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; Laboratory tests performed in screning stage revealed Alanine aminotransferase (ALT) or aspartate aminotransferase (AST): > 1.5 upper limit of normal (ULN); Laboratory tests performed in screning stage revealed thyroid stimulating hormone (TSH); Woman in pregnancy or lactation period; 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; Have alcohol abuse or drug abuse 1 years prior to screening; Has hypersensitivity or allergy to investigatory drug, comparatory drug or related supplements; Has participated or been participating other clinical trials(non-interventional study is excluded); Has an uncotroled disease, such as has a history of significant central nervous system (CNS), cardiovascular, pulmonary, hepatic, renal, or mental or psychological disorders with drug treatment that,in the opinion of the investigator, would not be suitable for participating this clinical trial. In the opinion of the investigator, the patients with other situation would not be suitable for participating this clinical trial.
Facility Information:
Facility Name
The Fisrst Affiliated Hospital of NanChang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
34336894
Citation
Shu X, Zhu Z, Fu Y, Zhang Z, Wang J, Li X, He S, Fan H, Liu S, Zhang G, Tang J, Huang C, Du Q, Wang X, Xu B, Du Y, Chen Q, Wang B, Chen Y, Duan X, Xie Y, Huo L, Hou X, Lu N. Mucosal Healing Effectiveness and Safety of Anaprazole, a Novel PPI, vs. Rabeprazole in Patients With Duodenal Ulcers: A Randomized Double-Blinded Multicenter Phase II Clinical Trial. Front Med (Lausanne). 2021 Jul 14;8:690995. doi: 10.3389/fmed.2021.690995. eCollection 2021.
Results Reference
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A Phase 2 Randomised Controlled Trial to Evaluate Efficacy and Safety of Anaprazole in Patients With Duodenal Ulcers.

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