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

Primary Purpose

Duodenal Ulcer,DU

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Anaprazole Sodium
Rabeprazole
Rabeprazole Placebo
Anaprazole Sodium Placebo
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 - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Anaprazole Sodium + Rabeprazole Placebo

    Rabeprazole +Anaprazole Sodium Placebo

    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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    December 30, 2019
    Last Updated
    December 30, 2019
    Sponsor
    Sihuan Pharmaceutical Holdings Group Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04215653
    Brief Title
    A Phase 3 Randomised Controlled Trial to Evaluate Efficacy and Safety of Anaprazole in Patients With Duodenal Ulcers.
    Official Title
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 20, 2020 (Anticipated)
    Primary Completion Date
    February 15, 2021 (Anticipated)
    Study Completion Date
    February 28, 2021 (Anticipated)

    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 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.

    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 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    448 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Anaprazole Sodium + Rabeprazole Placebo
    Arm Type
    Experimental
    Arm Description
    administered orally once every 30-60 minutes before breakfast for 4 weeks
    Arm Title
    Rabeprazole +Anaprazole Sodium Placebo
    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
    administered orally once every 30-60 minutes before breakfast for 4 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Rabeprazole
    Intervention Description
    administered orally once every 30-60 minutes before breakfast for 4 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Rabeprazole Placebo
    Intervention Description
    administered orally once every 30-60 minutes before breakfast for 4 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Anaprazole Sodium Placebo
    Intervention Description
    administered orally once every 30-60 minutes before breakfast for 4 weeks
    Primary Outcome Measure Information:
    Title
    The endoscopic healing rate of duodenal ulcers at week 4, evaluated by blinded independency central reading.
    Description
    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.
    Time Frame
    Treatment of 4 weeks
    Secondary Outcome Measure Information:
    Title
    The endoscopic healing rate of duodenal ulcers at week 4, evaluated by investigator reading.
    Description
    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.
    Time Frame
    Treatment of 4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 18-70 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 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) or free triiodothyronine (FT3) and free thyroxin ( FT4) : > upper limit of normal (ULN); 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, 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. 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; 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; In the opinion of the investigator, the patients with other situation would not be suitable for participating this clinical trial.

    12. IPD Sharing Statement

    Learn more about this trial

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

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